FDA Uses AdComm Process To Shine Light On Ampligen’s Troubled Development

December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.

Disagreements between sponsors and FDA in scientific interpretation of clinical data often get only a one-sided treatment in public discussions. With the agency generally precluded from disclosing information about pending INDs or NDAs, it is at sponsors’ discretion to publicly reveal any details about FDA concerns with their applications.

One exception to the non-disclosure restrictions on the agency, however, is the advisory committee process.

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