It looks worse than I thought...
Okay, so this analyst has been trashing Hemispherx for months, but primarily because he seems to have been one of the few looking closely at the details of the ever-changing study 'results', and calling into question Dr. Carter's false proclamations.
Was about to hit the hay, when I saw his latest article, and it doesn't sound good at all:
"The FDA's complete response letter to Hemispherx -- summarized in the company's Tuesday night press release -- essentially instructs Hemispherx to start Ampligen's clinical trial program from scratch.
The agency's medical reviewers concluded that the two clinical studies of Ampligen submitted by Hemispherx "did not provide credible evidence of efficacy,
" according to the company.
In order to reconsider Ampligen for review, FDA instructed Hemispherx to conduct at least one additional clinical study in chronic fatigue syndrome. The study needs to test different doses
of Ampligen for a minimum of six months, including at least 300 patients
on Ampligen dose regimens intended for marketing, according to Hemispherx's summation of the FDA's letter.
Hemispherx could find meeting the FDA's demands exceedingly difficult and expensive. If the FDA requires 300 patients treated with Ampligen in a new pivotal study, for example, Hemispherx would probably have to enroll 450 total patients at a minimum (assuming two patients treated with Ampligen for every one patient treated with a placebo to act as a control.) By comparison, the Ampligen phase III study submitted and rejected by FDA enrolled just 230 patients total and took six years to complete.
But the FDA is asking for even more from Hemispherx, including tests of Ampligen in rodents to rule out the risk of cancer and a safety study in humans to ensure that Ampligen doesn't cause dangerous changes to a patient's heart rhythm.
Ampligen's manufacturing problems, previously flagged by FDA inspectors, also remain unresolved
, the company said Tuesday."
I don't see how this could possibly be turned around, unless of course stockholders (and maybe patients) demand Carter's resignation?