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There’s been more drama than ever the last few weeks. The latest debacle is The Street’s Adam Feuerstein’s (AF) latest take on Hemispherx Biopharma (HEB).

We received several emails over the weekend regarding The Street’s latest posting asking us to do a write-up. While we would like to do a write-up, we think the drug (Ampligen) has been well-storied in the blogs and news.

But for all interested, here’s some of the statements from around the web about what some consider the next VNDA, DNDN…

On Thursday June 4th, HEB puts out a PR that says Japanese scientists are psyched about Ampligen:

“…a new peer reviewed publication titled ‘Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses’ was published in Therapeutics and Clinical Risk Management 2009:5 125-132. The article summarizes ongoing research in which researchers conclude that Poly I:PolyC12U (Ampligen(r)), an experimental therapeutic, is the ‘most promising adjuvant candidate for mucosal vaccines.’ Poly I:PolyC12U (Ampligen(r)), an experimental therapeutic, was also “extremely important” in these studies, in that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone.”

On Friday, June 5th, AF says this:

“…the press release carried a June 4 dateline, the study highlighted was actually published in March. The publication of this Ampligen study was so important that it warranted a press release, yet Carter sat on the news for three months. The evidence is mounting that Carter is seeking to divert investors’ attention away from the delayed approval of Ampligen as a treatment for chronic fatigue syndrome.”

AF also points out some highlights from the article referenced in the PR:

…”the section of the article highlighting Ampligen is a republication of scientific work done in mice in 2007, published in the journal Microbes and Infection by many of the same authors.”

AF finally points out some issues which have troubled some investors:

“A regulatory package that contains data from a phase II study completed 15 years ago in 92 patients and a larger phase III study done five years ago that appears (by my latest count) to have four different sets of results, one of which clearly showed Ampligen failed. (The others indicate the drug barely met its primary endpoint with statistical significance.=)…If the FDA is taking Ampligen and chronic fatigue syndrome so seriously, then why hasn’t the agency granted fast-track status to the drug?”

Shareholders are pointing to this piece on Biomedreports, in which the author, M.E.Garza, defends HEB CEO William Carter and slams Feuerstein about not knowing about the gene malfunction that leads to CFS (chronic fatigue syndrome):

“Adam Feuerstein wouldn’t know good science if it bit him in the ass! I’m not going to say too much in direct response, actually. The record can be set straight on this matter by the government themselves. The same people who have already told us this is a serious gene malfunction that costs us north of $90 billion a year in lost wages and productivity not to mention social security benefits. It sounds like those guys are living twenty years behind in time.”

The Pink Sheet Daily also opened up with a tantilizing one-liner about HEB:

FDA’s latest delay on Hemispherx Biopharma’s Ampligen could be a signal that the agency is getting ready to approve the first drug to treat chronic fatigue syndrome.”

So who’s right? What’s going on? Why the FDA delay? Does Ampligen work in CFS? Will it get approved?

The stock tanked almost 50% on Friday after The Street’s article, but is back up today at $3.00.

Stay tuned…

Anonymous Tip? Comments? Contact us: hr AT iguanabio DOT com

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