BUSTIE B.B. reporting from the BIG APPLE on STOCK ANALYSTS saying DUMB THINGS AMPLIGEN $'s

[lartista]

PLEASE GIVE ME YOUR SUPPORT!!!! Place the video everywhere you see slams against AMPLIGEN. Adam has written me directly and he is trying to push down the price of Ampligen to hurt the company financially!

ADAM FEUERSTEIN's (from www.thestreet.com) writtten quotes:
"Ampligen is a toxic placebo. You deserve something that's effective, not a hoax and a scam from Hemispherx."
"Ampligen has been available for many years. Demand is nil."
"The demand for Ampligen is nil because the clinical studies failed. The drug has no meaningful clinical benefit. The data are clear on that. Why do you want to take a toxic placebo?"
"Drugs are not approved on anecdotal evidence. How much do you know about the history of Hemispherx and Ampligen? Do some research, you'll reach the same conclusion as I have."
"your assumptions are incorrect. Mark knew nothing about today's article. My hedge fund manager source is short, as i properly disclosed in today's column. He believes the Thermodox still will fail when results are released in January. Whether or not his views are made public today is immaterial to his position."
"What is false?" (look in the mirror by Francesca Owens)
"You want a treatment that doesn't work, wasting money and resources that should be better spent on developing an effective therapy. FDA doesn't approve drugs on anecdotal evidence or because a patient makes a YouTube video." (I call this dis-ing our YouTube support groups for chronic illness) (also so he wasn't paying attention because I listed numerous drugs and explained one doe not work for all!)
" I saw your YouTube video. Not convinced. Sorry for your illness. Ampligen isn't
your cure. " (dah! ME/CFS is incurable Adam, Have you done any reading?)
"oy. so much you don't understand." (THAT THE KETTLE CALLING THE POT BLACK! I say by Francesca Owens)

• Category​
  
  Education
• License​
  
  Standard YouTube License

 

[Esther12]

I'm confused by this... that's a bit of an understatement.

I'm not confident about the value of ampligen either, and understand why investors would be sceptical about the claims coming from Hermispherx.

The morality of shorting a small pharmaceutical company is pretty complicated though. I'm not sure what I think about that. Ummm... I'm going back to bed.

 

[justinreilly]

He says in his latest article that if Ampligen were effective, then more ME patients would be taking it. He didn't mention the $30K price tag and that only a handful of doctors in the world offer the treatment, only one of which, I believe, is in a major city.

 

[justinreilly]

I will say though that He isn't the only one who thinks that hemispherex has done a lousy job handling the FDA approval process.

 

[justinreilly]

Im glad Wall Streets most trusted news source, Busty BB, is on the case. Wearing two ties, now that's professionalism.

 

[AFCFS]

From Ampligen in the Pink By Tom Windler:

The drug has had a checkered past. The FDA put the drug on hold in 1991 during the Phase II trials due to concerns of hepatic toxicity, severe abdominal pain and irregular heartbeat. The manufacturer, who called themselves HEM Pharmaceuticals, solved that problem by hiring a PR firm! Indeed, the next year, the FDA allowed Phase II/III to proceed and they were allowed to charge for a "cost-recovery" price. In 1998, they were again cited by the FDA. This time they were slapped for illegally promoting Ampligen as safe and effective for CFS and for other illnesses.

Hemispherx has made friends in Congress, finding the money they gained from desperate patients and other means could buy influence. Representative James Greenwood (R-PA) and Representative Joe Barton (R-TX) have been staunch allies. Hemispherx also hired those most polictically active in the field to be on their various boards such as Anthony Komaroff, M.D., a member of the CFSAC, Staci Stephens, a member of the CFSAC, and Charles Lapp, M.D., a member of the CFSAC.

Hemispherx is already counting on FDA approval and is building a marketing team in this country. They acquired a Alferon N Injection from Interferon Biosciences just last year and have already contracted with nearly 100 sales representatives.

While the FDA representative at the first CFSAC meeting said "about 20" drugs were in the pipeline for CFS, Ampligen appears to be the only one. While I, for one, have spoken to too many patients who found the drug a terrible experience, FDA approval would not change my mind. A treatment that is based upon an unknown cause does not impress me. Even those physicians who insist it has efficacy seem to be monetarily rewarded by Hemispherx. If politics wins over real science, Ampligen will win FDA approval soon. Unfortunately, it usually does.

 

[AFCFS]

I'm confused by this... that's a bit of an understatement.

Im glad Wall Streets most trusted news source, Busty BB, is on the case. Wearing two ties, now that's professionalism.

For me, the video is hard to follow, finding it difficult to assimilate an oddly dressed journalistic working girl with balls (presenter's use of the word) that reports on Ampligen, suggesting PubMed articles, but then primarily relaying anecdotal experiences, which are hard to follow, while apparently venting on individuals, or classes of individuals for what, to allow a 30K drug with a relatively poor track record and that seems to be equally embedded in medical-political sway?

And not sure how the presenter knows that CFS has no cure. And really do not understand the use of the working girl metaphor, stating a steady steam of clients since Adam and Eve? Eve was a hooker? Didn't she give Adam the apple? - confusing and not sure what it has to do with Ampligen in even some stretch of linguistic endeavor. And not sure I want to know, what is being exposing at about minute 5:21, whether balls (presenter's use of the word) or crotch; in any case, I would rather not see it. No thanks. Glad the presenter has that pacifier. I now feel the need to take a shower.

 

[justinreilly]

The Ampligen in the pink article is very interesting.

Btw presumably the cost will decrease markedly if it is approved. I wonder how much the doctors get paid per patient. I know it is usual to pay doctors in trials, but am curious how much. I have heard that in some trials doctors get paid ridiculous amounts which has led to fraud in some cases.

 

[lartista]

Hi you guys... I do not have time to read the responses here but I will include one letter to numerous stock analysts who are writing me in private. I beleive my letter will explain who was my target market and my line of thinking. I do not need any one to agree with me as I am a maverick... and it was me i was offering for human sacrifice and the FISH CAME BITING JUST LIKE I THOUGHT!!!! Numerous stock people of money managing firms are nor listening just a little but to us and considering what the chronically ill have to say. Thank, francesca

"Dear EPE,
Unfortunately often the wall street area doesn't listen to the people who are ill. They read only information they want and they know nothing about the illness... really nothing about treatments and really nothing often of what they are writing about when it come to this illness.

I am an ex-wholesaler for accredited investments, ex-stockbroker with over 25 years experience and served 9 years in public office. I know why I was hired and how I was trained.

My point was in a stupid way to get the attention and then hold the attention of anyone in on wall street. Even if it means sacrificing ME and my reputation, I was willing to do so. ME/CFS has robbed our lives and made us invisible. I plastered the video everywhere on wall street and interesting enough the hits came in. I then saw the men talking about the illness and how they had seen my serious videos. I even started to see a compassionate side come out of wall street.

My accomplishments to date in life are greater than most people so for that, I was secure in offering myself up for human sacrifice and it worked...

The ampligen drug hearing is about helping really, really, sick people... I also wanted to see what was the best ADAM Feurestein had to throw out there as the majority of what he is lies out right lies, or manipulated points of view, fact very seldom enter into this. He showed his cards early, which will help Ampligen see in advance of the Dec 20th hearing what was being said on the street. I stayed in close contact with the AMPLIGEN people letting them know what I was doing and where they needed to be watching as soon as the analysts started writing.

I believe my little piece has influenced a small segment of wall street to listen to the educated sick people and see what they have to say. It is our lives after all and the drugs are for us, not for the stock market to decide our quality of life. That's all.

Yes ampligen is NOT the fix all... but the CDC has engaged in very likely misappropriation of millions of dollars of our funds to other illness. Why was wall street including that in their reporting... because they do not ask, and they do not really care. The federal employees hung 8 x 11 sheets over their desks saying... I am tired today... I must have CFS.

President Obama is aware of all of this and has assigned several of his key staff to follow this FDA event. Why was that not mentioned in all the reporting.

So I in no way am trying to be harsh with you... I just want to enlighten wall street a little better... sometimes diamonds in the rough are hard to spot.... for those who have ADLs of 3 to 6, and if ampligen gave them a 10% to 25% increase in functioning... AMPLIGEN is their world.

Yes Ampligen may have not done all the best, and may not work for every one (which it does not) and the specialist are trying to isolate in the blood testing who it works best for. That too was not mentioned...

If the medical industry isolates who responds to ampligen, then there could be an almost 100% positive response rate, how quickly would wall street turn towards ampligen versus bam-ing them.

Wall street also did not see how close in bed the FDA is with the CDC. With Obama looking in on them, the FDA even with this negative letter, had to change their posture with our illness after Obama's adviser spoke with them....

I hope this helps... if we (ME/CFSers) do not get a treatment, we are all at very high risk of cancer, Leukemia and lymphoma. My natural killer cell test function was 1.87%, near zero. Zero means cancer is at my doorstep. I take imunovir (and AIDS drug), I take an opioid drug (naltrexone) that heroin drug users take and MS people take. I take 3 grams of valcyclovir that people with herpes 1 and 2 take for 10 days, 1 pill a day for out breaks. I take 3 grams a day for life that is toxic because I have two types of herpes running through my blood infecting my organs....

So when someone looks at these other issues on the surface, they do not see the DIAMOND IN THE ROUGH. So I used my stupidity and my body to get a predominantly male industry listening and thinking... so I see it as a win for my people.

I hope this helps. WE ME/CFSers are desperate... I hope this helped... The illness patient community needs to be listened too.

I would be sincerely interested in your comments.

THANK YOU FOR YOUR TIME.
This is just to give you an idea... I KNOW WHAT I AM TALKING ABOUT AND I USUALLY SCORE 99% OF THE TIME in whatever project I touch...

AMPLIGEN will win... if it is not Feb 2013, it will be soon!

www.coloradolottery.com/GIVING-BACK/PROJ.../
(I wrote this winning grant plus 3 others for a total of 1/2 million raised volunteering by myself: Great Outdoors Colorado Jefferson Grant Ranch Nature Observation Park and Learning Gardens $90,000)
francescaowens.com
(I was reviewed by the Smithsonian)
beautyofthebeast.org/
(I had sponsors galore)
vimeo.com/53456299
(I do TV reporting in Italy now when I am stable)
www.nfwf.org/AM/Template.cfm?Section=Hom...
(I ran the Tiger art campaign volunteering for them)
www.cepf.net/Documents/tigerwatch_spring...
(I worked with biologist around the world)

Francesca/BustieBB

 

[lartista]

Sorry I still have no time to read responses but a new letter from JOURNALIST ARRIVED FOR ME BUT I WAS IN FLIGHT FROM ITALY SORRY
" What a wild week it has been. Hope your well. I wanted to run something by you. Yesterday I talked to a former FDA employee who wishes to remain anonymous. He has served on several fda panels and knows exactly what it takes for a drug like ampligen to get approved. He told me that for ampligen to win approval patient testimony must focus on ampligen and not just ME/CFS. If patients simply talk about the unmet need for treatment the FDA panel is likely to vote no and assure patients that they will fast track the next medication for CFS. The problem is that there is nothing even close for treatment. Patients must demand ampligen specifically and reference the FDA's own statement saying they believe CFS is serious and life threatening. They should mention the lack of efficacy and safety in other recent drug approvals for serious life threatening diseases. Most of all patients need to tell the panel that they are willing to take the risk for potential benefits. In summary

1. Patient testimony must include a plea for ampligen
2. Focus on FDA's statements that CFS is serious and life threatening. Reference other diseases with drugs approved with greater risk than ampligen.
3. Testimony should be clear concise and patients should tell the FDA they are willing to accept any risks for a potential reward with ampligen.
4. Patients must tell the FDA that they will not accept no for an answer.

If you can get this information out to any patients who will be speaking tomorrow it could make the difference. He is an expert and he knows exactly what it takes.
Also, he said you could reference him as former FDA panel member but he was not willing for obvious reasons to give his name out.

Fingers crossed,
JOHNNY"

 

[AFCFS]

(http://www.google.com/finance?q=NYSEAMEX:HEB)
At time of posting, it looks like investors would also appreciate those letters of testimony.

Also, he said you could reference him as former FDA panel member but he was not willing for obvious reasons to give his name out.

Fingers crossed,
JOHNNY"

So to follow suggested guidelines, am thinking:

Dear FDA,

I saw a letter posted on the Internet written by a guy named JOHNNY who stated that I could reference a former FDA panel member who wishes to remain anonymous (for obvious reasons, of course). Supposedly he knows what it takes to get a drug like Ampligen approved.

Now, I am not a shareholder, and I have no way of knowing if JOHNNY or the anonymous FDA guy are, but I did hear that some people have had some benefit from Ampligen; though not sure if it was more from the recent market spike and sell-off or from the drug itself.

I am willing to accept more risk with Ampligen than people who invest in it - which is quite a bit.

I simply will not accept no for an answer.

Thank you,

"Friend" of JOHNNY

PS: Sorry I do not have more to time to write, but I am considering travel plans to Burma and the Golden Triangle just in case the drug is not approved.

 

[lartista]

afcfs

View attachment 4273
(http://www.google.com/finance?q=NYSEAMEX:HEB)
At time of posting, it looks like investors would also appreciate those letters of testimony.

So to follow suggested guidelines, am thinking:

Dear FDA,

I saw a letter posted on the Internet written by a guy named JOHNNY who stated that I could reference a former FDA panel member who wishes to remain anonymous (for obvious reasons, of course). Supposedly he knows what it takes to get a drug like Ampligen approved.

Now, I am not a shareholder, and I have no way of knowing if JOHNNY or the anonymous FDA guy are, but I did hear that some people have had some benefit from Ampligen; though not sure if it was more from the recent market spike and sell-off or from the drug itself.

I am willing to accept more risk with Ampligen than people who invest in it - which is quite a bit.

I simply will not accept no for an answer.

Thank you,

"Friend" of JOHNNY

PS: Sorry I do not have more to time to write, but I am considering travel plans to Burma and the Golden Triangle just in case the drug is not approved.

View attachment 4273
(http://www.google.com/finance?q=NYSEAMEX:HEB)
At time of posting, it looks like investors would also appreciate those letters of testimony.

So to follow suggested guidelines, am thinking:

Dear FDA,

I saw a letter posted on the Internet written by a guy named JOHNNY who stated that I could reference a former FDA panel member who wishes to remain anonymous (for obvious reasons, of course). Supposedly he knows what it takes to get a drug like Ampligen approved.

Now, I am not a shareholder, and I have no way of knowing if JOHNNY or the anonymous FDA guy are, but I did hear that some people have had some benefit from Ampligen; though not sure if it was more from the recent market spike and sell-off or from the drug itself.

I am willing to accept more risk with Ampligen than people who invest in it - which is quite a bit.

I simply will not accept no for an answer.

Thank you,

"Friend" of JOHNNY

PS: Sorry I do not have more to time to write, but I am considering travel plans to Burma and the Golden Triangle just in case the drug is not approved.

View attachment 4273
(http://www.google.com/finance?q=NYSEAMEX:HEB)
At time of posting, it looks like investors would also appreciate those letters of testimony.

So to follow suggested guidelines, am thinking:

Dear FDA,

I saw a letter posted on the Internet written by a guy named JOHNNY who stated that I could reference a former FDA panel member who wishes to remain anonymous (for obvious reasons, of course). Supposedly he knows what it takes to get a drug like Ampligen approved.

Now, I am not a shareholder, and I have no way of knowing if JOHNNY or the anonymous FDA guy are, but I did hear that some people have had some benefit from Ampligen; though not sure if it was more from the recent market spike and sell-off or from the drug itself.

I am willing to accept more risk with Ampligen than people who invest in it - which is quite a bit.

I simply will not accept no for an answer.

Thank you,

"Friend" of JOHNNY

PS: Sorry I do not have more to time to write, but I am considering travel plans to Burma and the Golden Triangle just in case the drug is not approved.

Dear AFCFS,
i am guessing you might be making fun of that last post I made. I use the name Johnny as the stock analyst has disclosed who he is to me but he must remain without name. He merely wrote me yesterday trying to help. He is the author of this piece written for ampligen:
http://seekingalpha.com/instablog/6056361-macsjv/1372401-ampligen-patient-s-will-determine-approval

 

[lartista]

http://seekingalpha.com/instablog/6056361-macsjv/1372401-ampligen-patient-s-will-determine-approval
Ampligen: Patient's Will Determine Approval 11 comments

Dec 16, 2012 7:01 PM | about stocks: HEB
On December 20th, Hemispherx's (HEB) drug Ampligen will be reviewed by an FDA advisory panel. What's different about this meeting is patients will be the deciding factor. A series of events have taken place over the past few years that have finally shed some light on ME/CFS. I will explain in this article why Ampligen is going to get approved the unconventional way.
Patients with Myalgic Encephalopathy(CFS) have been ignored, disrespected, and, abused for years by the FDA and CDC. The disease is chronic and debilitating. Symptoms can vary from patient to patient but generally include debilitating fatigue, especially following any type of exertion; markedly decreased energy level; sleep disorders; cognitive (memory and thinking) problems; muscle and joint pain; headache; sensitivities to noise, light, foods, medications and chemicals; gastrointestinal symptoms; depression; mood swings; anxiety; and decreased libido (sex drive). ME/CFS affects every aspect of an individual's life - career, finances, activities, education, self-esteem, relationships, etc. Formerly secure and confident people lose self-esteem due to lack of productivity, difficulty engaging in pre-CFS activities, trouble keeping up with responsibilities, inability to care for others, weight gain and other appearance changes. These changes may cause friends and family to perceive them as "acting differently" and can often upset the balance in relationships. Many patients have even committed suicide. The primary effects of CFS are experienced by patients, secondary effects are experienced by everyone around them.
For purposes of this article, I will briefly discuss the history of this disease in relation to the CDC. ME/CFS has been around for over 25 years, and research done by top experts in the field show definitive proof of physiological factors associated with the disease, however the CDC has spent years doing considerable harm to research efforts by muddying the waters with their approach, focusing on psychological and "biopsychosocial" factors while ignoring the physiological. Even as late as 2010 the CDC did a population based study in an attempt to make a correlation between personality disorders and ME/CFS. The study used questionnaires filled with psychobabble and attempted to pass the study off as scientific data. The results showed 29% of CFS patients had at least 1 personality disorder compared to 7% in the well control(healthy patients.) The summary of results suggested that CFS was associated with an increased prevalence of maladaptive personality features, such as being non compliant with treatment suggestions, displaying unhealthy behavioral strategies and lacking a stable social environment. Needless to say, ME/CFS patients were not thrilled with the CDC. The study was flawed from the beginning and experts ripped it to shreds with ease. Ultimately, the study showed the CDC spent a load of money to tell patients with CFS/ME, (most who have lost their former lives to the disease, suffering with dreadful symptoms, losing support from friends and family, and having their physicians tell them to drink a red bull and stop complaining) that they showed signs of "neuroticism" defined as long term tendency to be in a negative emotional state. It's a wonder the NY Times didn't run the headline-CDC study -A scientific breakthrough: Bedridden patients found to be negative and depressed. I realize the last statement is a bit of dramatic flare on my part, but I think it nicely demonstrates the mindset of the CDC. This is just a glimpse of the destructive history between the CDC and the ME/CFS community. This negative history had a direct impact on any approval chances Ampligen had in the past.
So, why has the FDA pushed Ampligen to the side in the past? The truth is it has very little to do with efficacy, clinical trial endpoints, safety, etc. The last time Ampligen was up for approval was 2009. As shown above the CDC made it very clear to the public that ME/CFS didn't have a physiological basis. In fact the CDC's Dr. Reeves who was in charge of the CFS program until 2010, made it very clear that he believed the disease was psychosocial. Ampligen never stood a chance. To bring it down to the most basic level. The FDA was not going to approve an anti-viral medication for a disease the CDC considered to be a form of depression.
Cost has been mentioned by past committee members when discussing Ampligen for ME/CFS. Patients with this disease are professionals such as doctors, lawyers, bankers, artists, etc. When these people have to stop working and become disabled the cost of the disease increases. Some estimates are as high as 10 billion in the U.S. alone. Yes, Ampligen is expensive, but has cost ever stopped approval of Cancer medications, or drugs for MS and HIV treatments. Absolutely not, and no one at the FDA would ever vote to deny a drug based on cost for any other serious life threatening disease. Yet at every ME/CFS conference in the past, some committee member raises the topic of cost. Other's nod in agreement that Ampligen is just to expensive. All of this is just a more subtle way for the FDA to discredit and discriminate against ME/CFS patients. Almost every other serious debilitating disease has at least one FDA approved treatment. And whether a large or small patient population, every other disease state has more research funding and more credibility than ME/CFS. And what's more disturbing is ME/CFS is arguably one of the most debilitating diseases amongst the group. The chart below shows a few disease states and some relevant statistics. Notice that only $6 million in research was spent on ME/CFS, a fraction of the others. The treatments for the other diseases don't offer any cures, instead the majority treat the symptoms associated with each disease.



Disease
HIV(AIDS)
MS
RA
Schizophrenia
COPD
Cystic
Fibrosis
Parkin-
sons
(IBS)
ME/CFS

U.S. Prevalence
1.1 million
400,000K
1.3 million
2.1 million
$12 million
30,000
500,000k
25-55 million
1-4 million

U.S. drug market size
$10 billion
$10 billion
$16-18 billion
3 billion
$12 billion
1 billion
1 billion
$740 million
?

Research funding (NIH
$3 billion
$121 million
$225 million
$265 million
$108 m
$79 m
$151 m
$114 million
$6 million
These are just a few of the hundreds of diseases that get more funding with marketed products. The numbers for ME/CFS are disgraceful. When cost comes up in the discussion the public participants will remind the panel that approving Ampligen is a drop in the hat compared to other less debilitating diseases. Also, all of the diseases above have multiple FDA approved treatments. ME/CFS patients are simply asking for one.
Political pressure -In April 2011 at a Reno town hall meeting a patient advocate named Courtney Miller asked president Obama what the White House was doing to fund research for ME/CFS. The President responded by assigning his deputy chief of staff on policy Nancy-Ann DeParle, as his point person for ME/CFS working with the National Institutes of Health. The president asked DeParle to convey a sense of urgency about ME/CFS and to raise its standing.
Recently the CDC has changed its course, the CDC has announced that it's looking into chronic fatigue syndrome (ME/CFS) subgroups in the hopes of improving treatment options, discovering the underlying physiology, and nailing down a case definition. Instead of using its own researchers and its own definition of the illness, The CDC is going through seven ME/CFS specialists and their treatment centers. Nancy Klimas' Center for Neuro-Immune Disorders, Charles Lapp's Hunter-Hopkins Center, and Dan Peterson's practice in Nevada to name a few. These are some of the top researchers looking into the physiology of ME/CFS and they've spoken out against the CDC's previous research. As for the controversial inclusion criteria, the CDC says anyone diagnosed at one of these seven centers is eligible, meaning they're using the clinical definitions of the doctors who actually know what they're doing. Whether political pressure, or pressure from the ME/CFS community this is a major 180 for the CDC.
The FDA appears to have done an about face as well. On July 9th of this year the FDASIA bill was signed into law. Included is (Section X) of PDUFA Reauthorizing Performance Goals and Procedure (Fiscal Years 2013 through 2017) to enhance benefit-risk assessment in regulatory decision-making. . In drug regulation, this context relates to a good understanding of the severity of the treated condition and the adequacy of the existing treatment options. Additionally, patients who live with a disease have a direct stake in the outcome of the review process, and are in a unique position to contribute in weighing benefit-risk considerations that can occur throughout the medical product development process. Also in an effort to address serious unmet diseases the FDA has committed to the "enhancement of accelerated patient access to new medical treatments." With this regulation, the FDA is authorized to "approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 505(c) or section 351(a) of the Public Health Service Act." The FDA has already held a Stakeholder Meeting for this disease.
On July 11th Hemispherx Biopharma, Inc. announced that they had recently met with representatives of the U.S. Food and Drug Administration (the FDA). At the meeting the FDA informed the company that they could scrap a requirement for a new study in lieu of new analyses of data from Hemispherx's AMP-516 Phase III Clinical Trial (AMP-516 Trial) in support of its New Drug Application (NDA) for Ampligen. The move negated the complete response letter issued on Nov 2009 where the FDA told Hemispherx it would have to perform an additional phase 3 study to qualify for resubmission. On August 1st the FDA accepted the NDA for Ampligen, in the re-analysis of data from the AMP-516 study submitted to the FDA is an examination of the quality of life parameters in patients who either met or failed the primary endpoint (exercise treadmill testing or ETT). Hemispherx believes the data shows that patients who were able to continue on a treadmill for at least 25% longer than at baseline achieved significantly greater improvement in vitality, general health perception, Karnofsky performance score, and activities of daily living compared to those that improved less than 25% in ETT.
This brings us to the committee meeting on DEC 20th. The meeting will have historical significance whether Ampligen gets a yes or no vote majority. Currently ME/CFS has no FDA approved treatments, shocking because as classified by the FDA as a serious life threatening disease any objective observer should be scratching their head considering Ampligen has been trying to get approved for years. But, as shown above the playing field has changed in a dramatically.
Patients will decide the vote-The meeting will allow for the public to speak live, by letter, or video. For the hour and half allotted, the committee members are going to be hit with a tidal wave of force by ME/CFS patients who are angry, and fed up with the status quo. Some will share dramatic stories about how Ampligen saved their lives. Others will beg the committee for approval in hopes that they can try Ampligen and possibly restore their past lives. Some will scream in anger about being misdiagnosed for years because of the past policy's of the CDC and FDA. Others will cry as they tell of horrific experiences with insurance providers, and doctors who don't understand ME/CFS. I assure you this testimony will be more powerful than anyone can imagine. And now, according to the FDA's new policy's these patients will have a critical role in the decision process. Recently FDA's Janet Woodcocks said the patient community is the "guiding light" in determining what is an acceptable drug risk. Speaking at the Partnering for Cures meeting, she noted the need for an "adult conversation" about when drugs should be made available to patients. Be assured that everyone from the public who will attend the meeting can quote Janet Woodcocks comments on command. After all, are they really demanding the impossible? Ampligen is not a cure and will not work for everyone. The drug has side effects but no patients have died due to Ampligen, and the trials showed Ampligen and placebo groups experienced similar side effects. Arguments over efficacy are a recurring theme amongst the investment community. Recently a well known analyst wrote a scathing review about Hemispherx and Ampligen. His argument claimed that analyzing old data was not going to be acceptable to the FDA. He noted that efficacy from one study was shown to be statistically significant however when the same study was presented at a later conference it showed no statistical advantage for Ampligen. He also shows his ignorance by writing "What's worse, Ampligen's side effects or CFS? Sounds like a toss up" I could care less about the discrepancy he mentions in data. And his quote comparing mild side effects of Ampligen to the devastation of symptoms ME/CFS patients experience, exposes his lack of understanding with this disease. The FDA's new outlook clearly shows the concerns over efficacy in the trials have lessened. The FDA already agreed with Hemispherx on the challenge the company had with study design in clinical trials. Success varies between patients. Some patients consider getting out of bed during the day a grand achievement. The FDA acknowledged that efficacy was difficult to measure.
As stated above the FDA is under extreme pressure to get drugs approved for serious life threatening diseases. Lets not forget that the FDA has approved hundreds of drugs with far less efficacy than Ampligen. One example is Phizer's Xalkori for lung cancer, it proved to be effective in about 10% of patients. The drug went through 2 clinical trials with 255 patients and was approved in 6 months. Another example that relates to the FDA allowing a drug to speed through approval is AZT. The relationship between ME/CFS and HIV/AIDS is similar in many ways. In 1995 infectious disease expert Dr. Marc Loveless told congress "I have treated more than 2,000 AIDS and CFS patients in my career." "And the CFS patients are MORE sick and MORE disabled every single day than my AIDS patients are, except for the last two months of life!" In 1987 the FDA had incredible pressure from the Aids community to get a medication approved. With data showing deadly levels of toxicity and efficacy from one small subset of patients the FDA approved AZT in record time. The side effects of AZT make Ampligen look like a baby aspirin.
History repeats itself and pressure is again being applied only this time the ME/CFS has the president's support and his Deputy Chief of staff has already said they will be monitoring the situation closely.
Remember, the FDA stated that Patients will decide if a drug is worth the risk. The advisory committee will ask patients at the meeting if they accept the risk/reward for Ampligen. The answer of course is yes. Just ask the patient who reportedly stole Ampligen from a clinic, and tried to reproduce the drug in a laboratory only to distribute to other desperate patients. Or the countless patients who travel hours across the country to enroll in clinical trials. Mary Schweitzer paid out of pocket $20,000 a year for Ampligen for years, after having miracle like success on the product. From Mary's online diary "After receiving a final dose that day, I was called and told not to come back. The head of the medical practice where I was receiving my infusions died, and FDA made the practice re-apply. FDA then rejected the application, and also rejected a second try. There is no place from New York City to Washington, DC, where I can get into an open-label study and receive Ampligen." "It is, for now, lost to me." Mary and hundreds of others will be at the advisory meeting, and each and every one will giggle when the discussion about risk/reward comes up.
The approval of Ampligen is critical, not just for the treatment opportunities it can offer patients, but a yes vote will add credibility to the disease and open doors for improved research funds to educate primary care doctors across the country, enabling them to make quicker diagnoses adding years onto patients lives. Pharmaceutical company's will be licking their chops to invest billions into new innovative treatments. Just look at the numbers for HIV/AIds research. After AZT was approved an explosion of funds was provided for HIV research, new and better treatments have led to patients living longer healthier lives. Don't ME/CFS patients deserve the same?
Once Ampligen gets its yes vote from the Dec. 20th committee, investors should see an epic run up in stock price. 1-4 million patients in the U.S. alone have ME/CFS and Ampligen will be the only approved product. While it's difficult to judge the market potential, look at MS with 400,000 patients and a $10 billion market. Or Rheumatoid Arthritis with 1.3 million effected in the U.S. and $16-18 billion in sales. I think its safe to say the stock will fly.
I end this article with one final story about a patient I have had the honor of meeting through my research. Her name is Francesca Owens, and she is an International patient advocate with ME/(CFS). Francesca was contacted a few days ago by the FDA advisory committee for Ampligen and informed that her written testimony was accepted and will be reviewed by the committee prior to the Dec. 20th meeting. Francesca's story is unbelievable to say the least. Before ME(CFS) Francesca lived a life most can only dream of. She was a successful stock broker, held public office in Colorado for 9 years, wrote award winning grants to raise money for wildlife causes, was a competitive fitness champion, and had an internationally emerging art business helping wild tigers. ME(CFS) changed this incredible life of overachievement. ME(CFS) slowly began to rob her life and she eventually lost everything she worked so hard for. The disease was so crippling she became bedridden unable to perform the simplest tasks. It took 9 desperate years of suffering uncontrollable infections, urinating pure blood, hospitalization after hospitalization, open heart surgery, post-surgery strokes, heart rhythm problems and losing eye sight through optical nerve damage before she was finally diagnosed with ME/CFS. She also has cognitive impairment saying her " brain fog was so severe at times she could not count change to pay for a cappuccino" Unlike other patients with chronic debilitating diseases such as Aids or Multiple Sclerosis, who upon diagnose start a treatment protocol, Francesca's diagnoses was met with question marks. If approved, her Dr. would have immediately started her on Ampligen, instead, to keep her alive she was put on several experimental drugs borrowed from a variety of illnesses. Naltrexone, a drug for heroin addiction, valacyclovir used for herpes 1 and 2, HHV-4 and HHV-6 for Epstein Barr, prescription strength vitamin D and Imunovir or AIDS patients to help rebuild natural killer cells function. All of these medications have given her 4-6 hrs a day which she spends the majority of advocating for ME(CFS)research and treatment, helping patients around the world come to terms with the disease. She has a Youtube channel where she submits daily videos that chronicle her struggle and offer advice to other suffers. Francesca has even tried to get an Ampligen clinical trial started in Italy, but, because of the drugs status in the US, other countries are unable to help . Because the disease has been disregarded by CDC and FDA her former insurance company(which has since dropped her coverage) would not pick up the expense for all her medications, because their not approved for ME(CFS). Imagine hearing the countless success stories of patients lucky enough to be enrolled in Ampligen clinical trials all the while sitting on the sidelines helpless. Most people complain about the wait time at their Doctors office or the cost of whatever medication their on. Not ME(CFS) patients, they travel hours to see specialists, write letters to the president, or in Francesca 's case lobby a foreign country to start a clinical trial just to have access to medication. Yes, that's right, Francesca moved to Italy and recently attempted to convince the government to start a clinical trial for Ampligen. Francesca is one of approximately 1-4 million people in the US and 17 million worldwide that deserve the chance to get their lives back. The advisory committee will vote yes to approve Ampligen on DEC. 20th because of the tremendous pressure these patients have applied. The FDA can start to repair the damage it's done ignoring this disease for years simply by voting yes on Ampligen.
Francesca life could again be a beautiful symphony, and just maybe Ampligen will be her instrument. I for one, think she's worth it…

 

[AFCFS]

afcfs
Dear AFCFS,
i am guessing you might be making fun of that last post I made. I use the name Johnny as the stock analyst has disclosed who he is to me but he must remain without name. He merely wrote me yesterday trying to help. He is the author of this piece written for ampligen:
http://seekingalpha.com/instablog/6056361-macsjv/1372401-ampligen-patient-s-will-determine-approval

I am just presenting an alternate way that one might view it. But sorry, I am a bit confused then, as I thought the letter you were presenting was an actual quote, given the quotation marks that include the name JOHNNY.

 

[lartista]

I am just presenting an alternate way that one might view it. But sorry, I am a bit confused then, as I thought the letter you were presenting was an actual quote, given the quotation marks that include the name JOHNNY.

it is an actual letter. I left out his name and email... as he has asked me too... but the quality of the information needed still stands on it feet. He sent it to me after he spoke with some one who knew better. I merely placed it here for other to view...

 

[AFCFS]

http://seekingalpha.com/instablog/6056361-macsjv/1372401-ampligen-patient-s-will-determine-approval
Ampligen: Patient's Will Determine Approval 11 comments

Dec 16, 2012 7:01 PM | about stocks: HEB

I find the above mentioned article helpful in that it also gives a better view of MacsJV (AKA JOHNNY?):

Disclosure: I am long HEB. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

AND then a link to MacsJV's profile (formatting not maintained):

ABOUT
I have worked in the healthcare sector for over 10 years. I have a background in statistical analysis as well as biology. I have developed a system designed to uncover a company's true value. I primarily research and trade stocks in the biotech sector. My background allows me to analyze clinical data, to determine a drugs value. My investment strategy is simple, research a company from all angles to determine it's worth.. I buy undervalued stocks and hold until my target price is reached. I have never shorted a stock nor will I recommend one be shorted. I have benefited from articles on SA and I hope to offer some the same value in my articles.
See Seeking Alpha's policy on anonymous authors.

SNAPSHOT

• Description: Occasional investor. Trading frequency: Weekly
• Interests: Stocks - long

COMPANY
Currently, there is no company profile for MacsJV.
BLOG
Currently, there are no blog details for MacsJV.
Book
Currently, there are no book details for MacsJV.

- I think who wrote the article may be just as important as what the article says. I don't necessarily find anonymity an issue, but it also can bear certain limitations on interpretation.

 

[lartista]

it is wierd... I just know he found me in Italy and asked to use my name. Then he started asking me questions and locations where to find answers... I saw how much he wanted to help us. Then I found the idiot (Adam Feurestein) who care nothing about us or the illness and has a reputation of trying to kill good biotech companies driving their stocks down. I had no idea how high up Adam was but he also has this very bad reputation or questionable ethics int he eyes of the public. And the writer I call Johnny to respect his privacy keeps trying to help and he seems very well connected... the advice letter he sent me was right on the head... but I also know the FDA loaded the broad up at the last minute with adding about 6 people to the board. The board has about 6 vacancies and that alone could make any vote a swing vote.

 

[dannybex]

I'm sorry, but I don't get it. Is this video supposed to be a joke or something? The FDA meeting is over, and while they were indeed moved by the patients testimony, they still by a 2-1 majority said that they recommended a new trial, with a larger selection of patients. Plus, they were not at all pleased with the way Hemispherx tried to remove patients who had the worst 'side effects' from the final results...

 

[lartista]

I'm sorry, but I don't get it. Is this video supposed to be a joke or something? The FDA meeting is over, and while they were indeed moved by the patients testimony, they still by a 2-1 majority said that they recommended a new trial, with a larger selection of patients. Plus, they were not at all pleased with the way Hemispherx tried to remove patients who had the worst 'side effects' from the final results...

the videos were for wall street... you need to follow the story from my YOUTUBE Channel. Stock analysts were writing to me early on both for and against Ampligen... The one bad unethical stock analyst was who these videos were directed at... but the good stock analysts were writing in with their disgust for ADAM... This all happened before the meeting when wall street was trying to create a crash in ampligen's stock before the Dec 20th meeting. The good analysts were afraid to take Adam on because he dismembers people... the character got to Adam without him being able to hurt me and the good wall street guys then followed the story and started writing more positive things about ME/CFS

 

[dannybex]

With all due respect, the stock didn't tank because of anything an analyst wrote, it tanked because Hemispherx didn't do what the FDA asked it to do, and it messed with the results of it's earlier drug trials.

I'll check out your youtube channel, but I suggest you check out the other threads here about Hemispherx and the FDA hearings, not to mention the replies on this thread.