View the Post on the BlogTry to leave your calendar open from 8am-5pm EST on the 20th for the FDA's hearing in Ampligen!
Information about the meeting is available at December 20, 2012 Meeting of the Arthritis Drugs Advisory Committee (not mistitled!).
The webcast will take place at https://collaboration.fda.gov/aac122012/ and Phoenix Rising will attempt to embed the video locally to make it easier to simultaneously watch and comment.
We'd appreciate it if pre-meeting discussion can be kept to the forum thread from this post, just to make life easier for the moderators (and to keep from having to merge a zillion discussion threads)
We'll make another post the day of the meeting for discussion about the meeting as occurs…so take some time on the 20th to join in the discussion here/in the forums or in chat!
See you on the 20th!
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Make Room on Your Calendar 20 Dec for the Live Webcast of the FDA Ampligen Hearing
- Thread starter Phoenix Rising Team
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Yes, the ETT is such an essential and strong, objective aspect of this study that I hope Dr. Snell has a chance to make the necessary points to the committee.
From the trial paper (March 2012):
"Cardiopulmonary exercise tolerance (ET) testing is an objective
measurement of treatment efficacy for fatigue and is accepted as a
regulatory standard for drugs ameliorating exertional fatigue by
exhibiting an average improvement of at least a 6.5% in intragroup,
placebo-adjusted ET [16–19]. The Phase III multi-center,
double-blind, placebo controlled trial reported here uses ET as its
primary endpoint and the reduction in drug usage for symptom
relief as one of several secondary endpoints in the evaluation of
rintatolimod in the treatment of CFS/ME."
That is not good enough for most clinical trials, but FDA should make an exception and grant PROVISIONAL APPROVAL because ME/CFS patients have no other prospects and Hemispherx had to go into this blind with no idea how to measure outcomes. The company should be rewarded because they took a risk and found something that very likely helps some people.
I don't know what you mean by "ME/CFS patients have no other prospects", unless you mean drugs. ???
At one point I suppose they did. But they made a ton of money in June 2009 when they released false reports that the FDA was about to approve Ampligen, sending the stock from something like 50 cents to over $4.00. Someone made a lot of money during that period...
I wondered why he'd stopped tweeting - phew!