The Hemispherx (HEB) Controversy

The Hemispherx (HEB) Controversy post image

For many this is starting to look like a soap opera, but contrary to the TV version, this is extremely exciting. Obviously, we’re talking about Hemispherx Biopharma (HEB) and the big question will the FDA give its thumbs up to bring Ampligen to the market.

The introduction to the next episode was given on Tuesday morning when HEB issued a press release saying the FDA may require one or two additional weeks before it reports to the Company. As you may remember, the PDUFA date (the target date for the FDA to report to a company) was May 25, 2009. The reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report.

Another item that was mentioned in the release, and what we found very interesting, was the fact that the FDA didn’t request additional information from Hemispherx at this time.

The release triggered a tremendous amount of speculation on the message boards of various websites as to what it meant and if it was a good or negative signal by the FDA.

The following days, also a number articles were published by informed and… not so informed authors. Underneath we’ll give you a short run-down.

A very helpful and informative article was published on Wednesday by The Pink Sheet DAILY titled Hemispherx’s Ampligen Poised To Become First Approval For Chronic Fatique Syndrome. The Pink Sheet DAILY is a news service for and about the pharmaceutical industry.

Next came Thestreet.com, which published Hemispherx’s CFS Drug Is a Long Shot. Thestreet.com is one of those big media outlets for which we warned last week. These guys simply cover “HOT” stocks without having the necessary background or knowledge. Thoroughly researching a complicated biotech company like Hemispherx takes days. Time, most of those writers don’t have. So they quickly look up some facts, form an opinion and start writing.

And let’s face it, who can blame them. The article undoubtedly attracted thousands of visitors to their website and that’s what matters. Is the analysis wrong or right? Who cares. The next hot stock is already waiting to be written about.

Finally, on Friday we had another excellent editorial by BioMedReports.com, titled: The Plot Thickens for HEMISPHERx Biopharma.

No matter who writes what, we’ll have to be patient some more to find out what the FDA has to say.

What do you think, will we see approval this week?

Photo credit Brandon Cirillo

2 comments… add one
  • Briam Jamaica Murphy May 31, 2009, 3:08 pm

    Lets see, ampligen has been the company’s focus for TWENTY YEARS with big insider ownership, very positive clinical results from I-III, two institutional investors bought $16M of stock WHILE THE COMPANY WAS DAYS AWAY FROM HEARING FROM FDA (if that’s not bullish, I don’t know what is – institutional investors don’t make that kind of crapshoot investment), with the recent FDA ‘delay’ of 1-2 weeks, the stock kept climbing on higher volume unlike the March announcement when it plunged (another strong bullish indicator), with no current treatment for CFS available IN THE WORLD – can you imagine what the share value will be for the company that brings the first Chronic Fatigue Syndrome medication to the global market ($$$$$) — AND — investors should not forget that HEB has already been requested by the Japanese government to essentially fast track its S1N1 flu vaccine program so it can be implemented in that country ASAP. Do your own homework people and add this company – Hemispherx – to your own successful portfolio………..Jamaica no problem mon

  • dominic fabrizio de la dominica May 31, 2009, 7:43 pm

    Unlike Adam Feurestein’s article that totally misrepresents HEB on numerous levels, there have been NUMEROUS publications that support Ampligen and what it has been working so hard to accomplish for the last 20+ years — create a treatment for CFS. Dr. Carter et al @ HEB have put their hearts/resources into this drug with the attempt to put people’s lives back in their own hands. With 4 million + people suffering on both ends of the spectrum with CFS, there really is only 1 drug poised to give these people releif. Here is a “fun-fact” -The US already uses ampligen in extreme CFS cases to releive those with elevated and downright debilitating form of the disease.

    In response to Jamaica-Mon – I couldn’t agree with you more on the approval of ampligen – many “big-hands” in the pot now wanting to get then next Vanda—-Is this it? Many tend to think so.

    Stay tuned for the Monday Morning Madness, or “MMM” as I like to call it!

    -D

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