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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