Hemispherx BioPharma (HEB)

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I emailed FDA yesterday, but it seems it doesnt matter what you ask them, you get a generic response: (check out how some words are misspelled, they need a spell checker)


"Dear ******************,

Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).

We do appreciate that you have contacted us and the time and effort spent in your communication. We understand your concern and we are aware of the extent of public interest in Ampligen.

However, we cannot discuss or offer any information on Ampligen inasmuch as all such information is confidential according to 21 Code of Federal Regulations (CFR) 314.430, and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public.

For background information, the Advisory Committees (AC) do not review review drug applications. The ACs operate in a purely advisory capacity.

Best regards,
Drug Information BLS
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
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