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The Next Step for Hemispherx's Ampligen

Another week has passed and still no word from Hemispherx Biopharma (HEB) on the approval of its chronic fatigue syndrome drug Ampligen.

Here's a prediction, more of a hunch, based on recent events: Hemispherx will soon announce that because of the current flu pandemic, the company has decided to withdraw its Ampligen application from the U.S. Food and Drug Administration. Instead, the company will focus all its resources on working with its "international partners" to develop Ampligen as an adjuvant flu vaccine booster.

Why would Hemispherx take this action? Because the company suspects that the FDA isn't going to approve Ampligen for chronic fatigue syndrome any time soon and certainly not before the company runs another lengthy and expensive clinical trial. The first study was a mess, as I've reported.

By pulling Ampligen from the FDA, Hemispherx wouldn't have to acknowledge the FDA's rejection but could spin the decision as its own choice. And the FDA couldn't say anything publicly, either.

And then, of course, CEO Bill Carter would be free to hype Ampligen as some magic elixir against the H1N1 and Avian flu strains, just like he's done in the past touting Ampligen as a treatment for HIV, the ebola virus, SARS, smallpox and whatever else he can think up to keep retail investors interested in the company.

And like all those past hoped-for-but-never-realized Ampligen claims, the new focus on flu won't amount to anything. Carter is a master at taking a kernel of truth and surrounding it with enough hype to make it sound believable.

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