Replies to post #10555 on Hemispherx BioPharma (HEB)

[Jumpinjackas]

what data did fda ask for?
safety issue or efficacy issue?

[JohnnyD3]

A lot has happened in 3 years, you cannot really make a direct comparison. The drug was not rejected. The FDA recommended a larger Phase III trial. In 2009, the FDA did not consider CFS a "serious and life threatening disease" and approval for drugs other than serious or life threatening, the FDA almost always required 2 Phase III trials. (The 2009 submission was with 1 phase III and 1 phase II)

And with the new FDASIA law - the rules have changed completely. The FDA now considers CFS a 'serious and life threatening disease" - language straight out of FDASIA.

This article very succinctly outlines what will be presented to the Advisory Committee

http://www.proactiveinvestors.com/companies/news/37948/hemispherx-awaits-fda-decision-on-ampligen-nda-for-chronic-fatigue-syndrome-the-pink-sheet-daily-37948.html

If you were on the committee - what reasons would you give for voting no?