Ampligen approval granted extension by FDA

[Firestormm]

Okay, I'm really shocked that the stock price has tumbled so quickly. That can't be good...

http://www.fool.com/investing/general/2012/12/18/hemispherxs-unsurprising-45-plunge.aspx

"Apparently, the agency disagreed with that approach as ​

negative briefing documents​

ahead of Thursday's advisory committee meeting sent shares down 45%..." ​

Holy crap! That's terrible. Now trading at 0.368. The video attached to your article above is worth a listen, thanks Danny. Looks like that FDA briefing document was really taken to heart. That has to reduce the chances of approval significantly.

 

[dannybex]

Yeah...even though I was never holding my breath (at least in this case)...IHMO that's really bad news, and from what I read of the FDA document last night, it seems like they're really pissed at the way the Hemispherx may have withheld information about adverse effects, removed like 20 or so patients from the original analysis to make the outcomes look better, etc..

I feel bad for the folks who were/are helped by ampligen, like Mary Schweitzer...

 

[Firestormm]

Yeah...even though I was never holding my breath (at least in this case)...IHMO that's really bad news, and from what I read of the FDA document last night, it seems like they're really pissed at the way the Hemispherx may have withheld information about adverse effects, removed like 20 or so patients from the original analysis to make the outcomes look better, etc..

I feel bad for the folks who were/are helped by ampligen, like Mary Schweitzer...

I never read the release Danny so I can't comment on that although enough was said I think about their last attempt at re-analysis of data at the time. If the FDA review panel approve - then I think stockholders will have cause to complain if the release is as dire as it appears. Always was a very speculative investment and the performance is no guide necessarily to the likely outcome - except - I think in this instance; in probably is. There is also the expense of this drug, and the uncertainty surrounding what exactly it actually does that can possibly be seen as part and parcel of CFS. I don't think enough has been done to try and discover how Ampligen might be working - and why it only appears to help some people. Anyway, today's the day. We shall have to wait and see.

The drug changed committees in 2011, but the data Thursday's committee will be reviewing is an analysis of the information Hemispherx submitted three years ago. Although the briefing documents are for reference and do not indicate judgment, the notes show the committee is cross-referencing past experiences with present ones.
Among the FDA's notes:

• Hemispherx did not conduct any dose ranging studies, but noted in the complete response that the minimal effective dose is 200mg twice a week.
• FDA finds fault with the remix of the exercise tolerance data, which is meant to assess patient activity thresholds. The FDA notes indicate Hemispherx's approach was flawed because it included a variable endpoint, among other reasons, including “there is no evidence suggesting that improvement with Ampligen is more likely in patients who may spontaneously improve.”

http://www.mmm-online.com/fda-committee-set-to-review-chronic-fatigue-drug/article/273345/

 

[Nielk]

Live webcast starting in 2 minutes at: https://collaboration.fda.gov/aac122012/