Hemispherx's Ampligen Rehash Unlikely to Impress FDA

Following a meeting with FDA officials in June, Hemispherx claims the agency agreed to review the new analyses of the Ampligen study in lieu of data from a new clinical trial. However, Hemispherx also warned that, "Whether these data provide adequate evidence of efficacy will ultimately be a review issue, and there can be no assurance the FDA will conclude the data are adequate to support approval of the Ampligen NDA."

Investors would be wise to take that warning seriously.

A postscript: Omitted from this column is a retelling or discussion of Hemispherx management's questionable actions and misleading statements made during the previous Ampligen review cycle in 2009. I covered Hemispherx extensively during this period, so feel free to go back and read my prior stories:

Hemispherx's CFS Drug Is a Long Shot

Hemispherx Builds False Hope on Old Data

Hemispherx, in FDA Limbo, Seeks More Cash

Hemispherx Hasn't Called FDA on Ampligen Review

Hemispherx Cops to Ampligen Delay

Hemispherx's Ampligen Dealt Fatal FDA Blow

--Written by Adam Feuerstein in Boston.



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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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