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Dec 20th: High Noon for Ampligen! FDA Advisory Committee Decides Ampligens fate in live webcast

urbantravels

disjecta membra
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Los Angeles, CA
There is a piece on the NCF site by a patient who says she was in a trial and she and several others dropped out bc of adverse effects, but that they weren't counted as having adverse effects, just shown as being dropouts.

Shades of PACE!
 

Hope123

Senior Member
Messages
1,266
Justin, I've read the whole post at that link and I don't see any mention of patients dropping out due to adverse effects that weren't reported as such in the studies. Was that mentioned in some earlier post by the same person, perhaps?

I haven't read those links and the FDA briefing document is long. However, I skimmed some sections of the adverse effects chapters and the reviewers write exactly what concerns they had. FDA panel felt Hemispherix did not accurately count the number of people adversely affected nor rate the severity of their reaction accurately. There were definitely discrepancies.
 

Hope123

Senior Member
Messages
1,266
WSJ said 8 to 5 against, and Nature above - said 9 to 4 against. Go figure! :) Maybe different votes? I don't know.

There were multiple questions put to the FDA panel. So it depends on which questions they're writing the vote about.

Question by question and vote:
http://news.yahoo.com/fda-advisory-committee-makes-recommendations-195759063.html

The one person who did not vote was not an "abstainer"; this person was a designated non-voting member ahead of time so that the total number of voters was 13.
 

Hope123

Senior Member
Messages
1,266
Justin, I've read the whole post at that link and I don't see any mention of patients dropping out due to adverse effects that weren't reported as such in the studies. Was that mentioned in some earlier post by the same person, perhaps?


If you go to the link "Ampligen in the Pink", it's there.

 

Hope123

Senior Member
Messages
1,266
All I can say is that I have heard EVERYTHING can send people worse than how they started, I read people from Imunovir, LDN, Mb12..... So in this disease is not unique to Ampligen, Everything we try can or get us worse, or same, or better.

It is difficult to predict how any one individual will react to a drug since there are such things as idiosyncratic reactions and they include death. However, when I make a choice about what drug to take myself or, in prior work, give to someone else, I do rely on the probability of reaction by looking at how the drug has perform in groups of people. And a lot of people here do that as well.

The safety data on Ampligen is based on 200-300 people tops and is spotty at that (unclear or ?deceptive reporting by the company, only following patients for a few months, etc.) whereas Immunovir has decades long safety data I believe in the thousands and similarly, LDN has been used in hundreds of thousands of people in higher doses than CFS for reversing the effects of opiods for a long time ( in fact, I've used it in this way on patients before) and in lower doses in other diseases as well. So although the data is not necessarily in people with CFS, I am more reassured about those medications than Ampligen.

The prevalence and severity of side effects should also be noted. A 1% chance of a side effect is different than a 20% chance and being permanently worsened by a drug is different than having mild stomach issues for a few days.
 

Firestormm

Senior Member
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5,055
Location
Cornwall England
Company Press Release:

21 December 2012: http://www.nasdaq.com/article/fda-a...-fatigue-syndrome-20121221-00738#.UNWIYKya_To

PHILADELPHIA, Dec. 21, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.(NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced the outcome of the meeting of the Arthritis Advisory Committee (the "AAC") of the U.S. Food and Drug Administration (the "FDA") on the New Drug Application ("NDA") for Ampligen® for Chronic Fatigue Syndrome ("CFS").

On the question: "Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.

On the question: "Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.
On the question: "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?," the AAC voted 8 yes, 5 no and 1 non-vote.

On the question: "Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of CFS?," the AAC voted 8 no, 5 yes and 1 non-vote.

Hemispherx is committed to the Ampligen® clinical development program and to bringing Ampligen® to market to ease the suffering of those seriously afflicted with CFS. The Company will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen® is a safe and effective treatment for CFS.

The AAC based its voting on a review of data from the Ampligen®clinical development program included as part of the Company's NDA submission. This submission included data on nine studies conducted in patients with CFS, including two pivotal studies and seven supportive studies. The trials were designed to evaluate safety, tolerability and efficacy in the approximately 845 patients (589 unique subjects suffering from severely debilitating CFS) who received Ampligen®.

The majority of the AAC members expressed the view that an additional controlled clinical trial of Ampligen should be conducted prior to the FDA granting approval.

The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013.

The FDA uses committees, like the AAC, to obtain independent expert advice on scientific, technical, and policy matters to assist in its mission to protect and promote public health.

The FDA is not bound by the AAC's recommendation, but will consider their recommendation in its review.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain FDA approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome.

The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA.

These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may follow the AAC's recommendation and decide not to approve the Ampligen® NDA; (ii) the FDA may ask for additional data, information or studies to be completed or provided prior to approval; (iii) the FDA may require additional work related to the commercial manufacturing process to be completed prior to approval or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved; (iv) the FDA may determine that the complete response submitted by Hemispherx is not "complete," potentially requiring the Company to conduct additional activities before it can re-file, if at all, the complete response; and (v) until completion of the FDA review of the Ampligen® NDA and final approval of the product and prescribing information, if any, the specific patient population for which Ampligen® may be indicated will not be known. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen® NDA.

....

HEB Closed @ $0.28 down 22.2% on the day.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
24 December 2012: Class Action Launched against HEB for non-disclosure:

...The Complaint alleges that throughout the Class Period, the Company made a host of materially false and misleading statements regarding the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen's clinical trials. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On December 18, 2012, the FDA published an FDA staff report concerning Ampligen's safety and efficacy.

Specifically, the report concluded that the Company's studies were "ill-defined and invalid" with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, "it is difficult to draw conclusions regarding potential safety signals," but the "review identified nine potential safety concerns associated with Ampligen."
As a result of this disclosure, Hemispherx shares declined $0.276 per share or nearly 43%, to close at $0.368 per share on December 18, 2012.

As a result of Company's wrongful acts and omissions, and the precipitous decline in the market value of the Company's securities, Class members have suffered significant damages....

http://www.nasdaq.com/article/share...rx-biopharma-inc--20121224-00143#.UNlNDaya_Tq
 

urbantravels

disjecta membra
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1,333
Location
Los Angeles, CA
It's interesting that the lawsuit (at least according to this report) does not reference the Dec 20 recommendation by the committee to reject Ampligen, but rather the release of all the damning pre-meeting information on Dec 18, which caused the stock price to plunge in advance of the committee meeting.

The information released on Dec 18 continues to make me wonder: Why did the FDA let things advance to the stage of having the committee meeting if they already thought the information HEB was giving them was so bad, & thus probably thought the rejection would be a foregone conclusion? I suppose there is value in having everything brought out into the open in a public meeting; a lot about the disease and its burdens was aired to a (potentially) new audience, and the FDA got the chance to give assurances that they do consider the disease serious, and do want to work with drug sponsors, which is important for both patients and the drug companies to know. But I don't really understand enough about how the FDA works to do more than guess.
 

CallieAndToby

Senior Member
Messages
137
Location
florida
It is difficult to predict how any one individual will react to a drug since there are such things as idiosyncratic reactions and they include death. However, when I make a choice about what drug to take myself or, in prior work, give to someone else, I do rely on the probability of reaction by looking at how the drug has perform in groups of people. And a lot of people here do that as well.

The safety data on Ampligen is based on 200-300 people tops and is spotty at that (unclear or ?deceptive reporting by the company, only following patients for a few months, etc.) whereas Immunovir has decades long safety data I believe in the thousands and similarly, LDN has been used in hundreds of thousands of people in higher doses than CFS for reversing the effects of opiods for a long time ( in fact, I've used it in this way on patients before) and in lower doses in other diseases as well. So although the data is not necessarily in people with CFS, I am more reassured about those medications than Ampligen.

The prevalence and severity of side effects should also be noted. A 1% chance of a side effect is different than a 20% chance and being permanently worsened by a drug is different than having mild stomach issues for a few days.

I can't take immunovir or LDN b/c of violent reactions, so I'm pretty much screwed. I'm going downhill fast and have already spent months and months being bedridden.

I know 5 people who were in the ampligen trials, all said it was hell the first 6-12 months, but all improved by 80%, one said his POTS disappeared, and one guy said his CFS went away. One of these people I speak of was completely bedridden for 15 years and now is able to work. Sucks we don't really have many treatment options. Imm. and LDN don't help everybody either so what are the rest of us supposed to do??
 

CallieAndToby

Senior Member
Messages
137
Location
florida
I think they also need to push approval of antivirals for cfs/me, they have a good idea on how to subgroup these patients. They are already indicated for other illnesses just need to add cfs/me with high viral titres etc.

These are the things that could stimulate more research into cfs/me. Maybe then big pharma might put more money into ampligen, we just need a spark to get things going?

I'd like to try antivirals, haven't been prescribed them yet but have no other options left. Would love to see more research into them yes. I feel like time is running out for people though, I have friends who have been sick for 20 years and they are completely bedridden and in such states of depression, how much more can they take?
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Firestormm - Do you think that Hemispherx knowingly mislead the public?

Probably not, Nielk. I don't think the company said as much as they could but then I haven't been following all the goings on as closely as some clearly have. This is what seems to be a bunch of investors suing the company presumably because they have either lost money or seen their 'faith' and investment value tumble. It does smack of 'double-dealing' when the company themselves capitalised on the speculation back in the Summer to raise $8million when the stock hit $1. That kind of thing never sits well with investors who have now seen the stock sit at around 0.27 cents but it's not illegal on the face of it. It's capitalism at it's 'finest' :)

Was asking elsewhere just how serious this class action might be. I mean it's not like the SEC have gotten involved. So is it really all that serious? I don't know. I do know that America doesn't hold back from pursuing legal redress for, well, just about everything :) If something was 'withheld knowingly' then surely the regulator would be involved?

What will come of this I don't know. Doesn't look to good for investors though. Which way with HEB go know? A new clinical trial? Will they use the money they raised? Or will that money be needed to settle this class action? Perhaps the details of the action will reveal the amount of damages they are seeking. But whether or not it will be successful - or is even reasonable and not 'sour grapes' - I really couldn't say at this point.
 

WillowJ

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WA, USA
I was never real clear about why they couldn't just formulate a narcotic with ibuprofen or naproxen or something else that wasn't acetaminophen - could never find reliable info about whether there was some pharmaceutical reason why that wouldn't work.

because instead of potentially harming the liver, these drugs can potentially harm the kidneys. There is some kind of meme that Tylenol is the safest pain medicine but I have never understood the merit to it. However I haven't checked the adverse report figures.
 

WillowJ

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Does remind me of frequent comments on Bloomsberg that the markets don't like uncertainty?

Surely if it wasn't for stock value fluctuations due to 'uncertainty' there wouldn't be any trading and hence no opportunity to make profits?

This is OT for this thread but I can answer that.

Different meaning of 'market'. The comment that the markets don't like uncertainty isn't meant to refer to the stock market, much less short selling or selling on the margin. It's meant to refer to the market broadly, as in Adam Smith's market (everything that is for sale or trade everywhere) with the supply/demand stuff.

This is the market where about half the businesses share comes from small businesses who by definition don't have (and probably aren't even thinking of) shares of stock; most of them are S corps and P corps (i.e. the are owned by a Single person/family, or by a Partnership of say, two or three persons [for example, siblings or close friends who launched a business together] and even some left still using their SSN for a TIN (Taxpayer Identification Number; i.e. they never incorporated or formed an LLC or any such at all, they are just Joe Bloe doing business as Joe's Towing)... they pay taxes at individual rates, I assume because they represent costs/risks borne by individuals; however the 'profits', if the business I used to work at was any indication of the norm, exist mostly on paper and any in liquid form are put back into the company in the form of bonuses, equipment costs, the next project, and the like, and yes, many do have employees; we aren't, by and large, talking about hobbyists, which collectively don't take up much market share). I don't know what percent of large businesses (which is where the C corps would be, which pay tax at the Corporate rate) are publicly traded.

So for the 'don't like uncertainty' bit, this comment relates to companies with employees, for the most part, acting in stable ways, not about paper/electronic representations of shares being bought and sold in the most unstable ways available.

In this case, yes, I agree, and this is my former job. Hiring or expanding is not going to happen when it's not known what the new rules and taxes are going to be. It's necessary to be able to predict. Because one has to plan ahead by years, to do anything. And one needs to know there's a good chance it can work. Otherwise one is putting at undue risk not only the resources (and good name) of one's self and one's own retirement and the care of one's family -- but also putting at undue risk the jobs and well-being of the people one employs. They would have put a lot of time and effort and often loyalty into the company. And it's not worth risking putting them out of work, just to try something that isn't well thought out. Or that there is a lack of information for. Certainly some companies do things that wreck the company and their employee's lives (temporarily, anyway--hopefully not permanently), and they get a lot of press. But I think it isn't the norm. Most companies would generally rather stick around--and keep people employed. So they'll usually wait until they hear what they need to know, to evaluate whether it's going to work or not.

That's why not knowing things, or short-term/expiring tax cuts, etc., doesn't help the economy (or not much). Because anything that's temporary or unknown, cannot help the long-range planning.
 

Nielk

Senior Member
Messages
6,970
Probably not, Nielk. I don't think the company said as much as they could but then I haven't been following all the goings on as closely as some clearly have. This is what seems to be a bunch of investors suing the company presumably because they have either lost money or seen their 'faith' and investment value tumble. It does smack of 'double-dealing' when the company themselves capitalised on the speculation back in the Summer to raise $8million when the stock hit $1. That kind of thing never sits well with investors who have now seen the stock sit at around 0.27 cents but it's not illegal on the face of it. It's capitalism at it's 'finest' :)

Was asking elsewhere just how serious this class action might be. I mean it's not like the SEC have gotten involved. So is it really all that serious? I don't know. I do know that America doesn't hold back from pursuing legal redress for, well, just about everything :) If something was 'withheld knowingly' then surely the regulator would be involved?

What will come of this I don't know. Doesn't look to good for investors though. Which way with HEB go know? A new clinical trial? Will they use the money they raised? Or will that money be needed to settle this class action? Perhaps the details of the action will reveal the amount of damages they are seeking. But whether or not it will be successful - or is even reasonable and not 'sour grapes' - I really couldn't say at this point.

From what I hear, it is not unusual for these litigation firms to sue publicly traded companies. This is pretty common here in the States. I also thought that what can they sue for already. Hemispherx doesn't seem to have money but I was told that companies have insurance for such things.
 

liquid sky

Senior Member
Messages
371
I can't take immunovir or LDN b/c of violent reactions, so I'm pretty much screwed. I'm going downhill fast and have already spent months and months being bedridden.

I know 5 people who were in the ampligen trials, all said it was hell the first 6-12 months, but all improved by 80%, one said his POTS disappeared, and one guy said his CFS went away. One of these people I speak of was completely bedridden for 15 years and now is able to work. Sucks we don't really have many treatment options. Imm. and LDN don't help everybody either so what are the rest of us supposed to do??

I know where you are coming from, Callie. I was hoping they would give some kind of provisional approval to Ampligen. It is obvious that it DOES help a subset of patients. They were there to testify. People are running out of options and out of time. This disease in its worst is sheer hell. Give the patients all the data and let them make a decision based on what they are experiencing. To just never approve anything in decades is brutal.
 

CallieAndToby

Senior Member
Messages
137
Location
florida
I know where you are coming from, Callie. I was hoping they would give some kind of provisional approval to Ampligen. It is obvious that it DOES help a subset of patients. They were there to testify. People are running out of options and out of time. This disease in its worst is sheer hell. Give the patients all the data and let them make a decision based on what they are experiencing. To just never approve anything in decades is brutal.
Exactly. Couldn't agree more. I feel really bad for the folks who have been sick 20+ years.