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

ballard

Senior Member
Messages
152
I have my fingers crossed for the big day. If Ampligen is approved it will mark a huge turning point in the history of treatment for us.

Does anyone know how Kelvin Lord is doing now? Has he had further treatment with Ampligen, or has he maintained his improvement?
 

Cort

Phoenix Rising Founder
Kelvin Lord is going to report on his progress in the near future..

It could be a monstrously big day for us...validation, new treatment options.....more interest in the immune system...more interest in Rituximab....one of the few real potential turning points we could have....

Its going to be exciting..
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I got a little excited :)...I talked to Kelvin the other day...and will let him report later but I can tell you that Ampligen was the best thing he ever took - and that guy has been around :)

I remember reading his blog. His was a real turnaround in terms of his health and it was great that he shared the info. I'm looking forward to hearing how he's doing.

I agree that Ampligen's approval would have a huge knock-on effect for us in terms of validation as a genuine immune illness deserving much more funding. Fingers crossed for Thursday.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
A huge day in the history of chronic fatigue syndrome with major implications for our future. Check it out here...

http://simmaronresearch.com/simmaro...s-ampligens-fate-live-on-webcast-on-dec-20th/

Well it is very good to see you posting Cort - been wondering where you had gotten to! :)

Unfortunately I do not share your optimism about Ampligen or about it's approval - which will occur in February 2013 and is not dependent on the decision of the review meeting.

In some respects of course a drug for CFS would be very welcome - but the data just isn't as supportive of the claims as it might be. This is a speculative company and the only money being made is from traders taking advantage of all this hype.

"...Dr. Andreas Kogelnik, who runs the Open Medicine Institute in Mountain View, Calif., puts the chances of FDA approval for Ampligen at just 50 percent. Although he is rooting for the drug to be approved, he says the FDA may require more data on collateral effects. This has happened in the past and the FDA has not been satisfied with previous applications.

I would suggest the chances are even less and I do worry that this event has been over-hyped and once again some patients - desperate patients - will be disappointed and left blaming the FDA.


See here (including your Simmaron article): http://forums.phoenixrising.me/inde...ted-extension-by-fda.14127/page-3#post-318641
 

Cort

Phoenix Rising Founder
Here
Well it is very good to see you posting Cort - been wondering where you had gotten to! :)

Unfortunately I do not share your optimism about Ampligen or about it's approval - which will occur in February 2013 and is not dependent on the decision of the review meeting.

In some respects of course a drug for CFS would be very welcome - but the data just isn't as supportive of the claims as it might be. This is a speculative company and the only money being made is from traders taking advantage of all this hype.



I would suggest the chances are even less and I do worry that this event has been over-hyped and once again some patients - desperate patients - will be disappointed and left blaming the FDA.


See here (including your Simmaron article): http://forums.phoenixrising.me/inde...ted-extension-by-fda.14127/page-3#post-318641


It'll be exciting...I'm hoping that even if the data isn't as good as it might be and even if the FDA doesn't have all the information that it might want that they recognize the need, recognize that the drug is safe and give it accelerated approval.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Here


It'll be exciting...I'm hoping that even if the data isn't as good as it might be and even if the FDA doesn't have all the information that it might want that they recognize the need, recognize that the drug is safe and give it accelerated approval.

Well that FDA briefing document released Tuesday, worked badly on the shares. Down 45%! Danny posted an article with video on the link above. Exciting? Yes. But I don't see how they can give it accelerated approval. They've already recognised a need to get something suitable onto the market as soon as possible - but Ampligen (based on the briefing document) does not appear to be it. If they were to approve now, then that would mean the briefing document was a sham. It appears to have led directly to the shares losing all that value - if they approve - investors will be incensed.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I agree..The FDA report was very harsh and was very disappointing reading..I would be surprised if they gave approval now....
Presumably the people advocating for Ampligen had access to the same information that the FDA was based on. It will be interesting to see what they have to say tomorrow.
 

Sparrow

Senior Member
Messages
691
Location
Canada
I can't decide whether I hope it's approved or not.

It seems to me that like many treatments for ME, it works great for some people and not at all for others.

I would love for the people who might be helped by it to have easy access to it. I would love for us to have a drug company behind us, since I think that would go a long way towards raising awareness of the immune components of the illness, and of the illness in general. I think awareness is the first key to making any real progress with doctors, treatments, research, etc., so that could be huge.

But by the same token, if most people aren't helped by it, I would hate to see the medical community end up using that as evidence that the immune system isn't involved after all. It's easy for people to jump to the wrong conclusions and throw the whole thing out, or at least shy away from the topic, when the reality doesn't live up to the hype. And I would hate to see future medications delayed in their approval because they didn't want to make the same mistake again.

In the end, I think it would probably be better for us if it was approved, but doubt it will be. But even if it isn't, maybe the whole process and the letters we wrote will help to raise some awareness in and of themselves. Every step towards making it known how badly help is needed is a good one.
 

Seven7

Seven
Messages
3,444
Location
USA
It would be nice if people start naming Markers in the presentations from patients, Is time to start pointing out the Biological gains Vs self reported Sympotoms.

Like My NK levels went up by X% and took me from bed to be able to work. Than just saying it took me out of bed and I am able to work.

Or any of the Cytokine regulations, titters went down by X%...... This will have big coverage and we need to present an immunological front!!!
 

JustJack

put on yer dancin' shoes
Messages
53
Location
Sacramento CA
"Well that FDA briefing document released Tuesday, worked badly on the shares. Down 45%"

Been watching all this for a long time. Shares dropped yesterday for several reasons, one, the FDA review docs. (which all knew in advance that they would stay negatyive), but sight all info from 2009, so can be refuted by testimony and bt Dr Carter. Two, a negative article by scam artist Adam F at street.com, and three, MM short selling causing stops to be run.

If, and I say if, A gets a majority vote tomorrow, it could be partial, meaning physicians get access, but more studies ongoing at HEB. I do know that HEB has spent lots to prepare for potential ramp in production of both Ampligen and Alferon. I, for one, prasy for Amp approval. I have wanted Amp for 15 years, but no access and cost prohibitive. There are so many like me, 15 yrs diagnosed, 5 years late stage and housebound. None of this means approval will come, but....hoping beyond hope (yes, we all suffer from the hope thing).
 

JustJack

put on yer dancin' shoes
Messages
53
Location
Sacramento CA
CONCLUSION from FDA prelim report for tomorrow...
"In summary, CFS is a serious, life threatening and unmet medical need. There are currently no FDA approved products specifically for the treatment of CFS. Ampligen has the potential to be a positive therapeutic option for patients with CFS who do not have an alternative to directly treat the condition. Given the overwhelming physical and cognitive health issues; the decrease in activities of daily living and overall lack of quality of life associated with CFS, Ampligen clearly represents a clinically meaningful advance for a significant unmet medical need, and the weight of evidence supports FDA goals to advance treatment for chronically ill patients with severe debilitating, life threatening, conditions such as severe CFS.
It can be stated that the burden of the symptoms associated with CFS is greater than any risks associated with Ampligen, since a CFS sufferer’s life may be at risk for years of debilitation often followed by premature death."
 

mezombie

Senior Member
Messages
324
Location
East Coast city, USA
Here's a good article that puts the FDA report in context. As the writer states,

"The problems facing Ampligen-or any putative therapy for CFS for that matter, is that the underlying cause(s) are unknown. As a result, there are quite possibly distinct sub-groups within any potential CFS study population with markedly distinct pathophysiologies, and hence efficacy measures would need to be tailored to the sub-group.

"Ampligen's trials had no way to account for this meta-population problem beyond looking for interesting trends within the data set. And that is what they did. In the briefing documents, the FDA referred to these statistical tests as a means for "hypothesis generating", not efficacy testing. As you can see this is a circular argument. No one seems to know what an appropriate biomarker for the general CFS population is, but the FDA is holding Ampligen up to an unrealistic standard nonetheless. In the end, HEB did find statistical support that Ampligen provides a biologically meaningful impact on the lives of at least some patients with CFS."

and

"Hemispherx is thus being penalized for the scientific community's willful ignorance on CFS for decades, and not being rewarded for taking a major risk of pushing Ampligen through clinical trials."


http://seekingalpha.com/article/1072481-hemispherx-faces-fda-day