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Biotech / Medical : Biotech Valuation
CRSP 54.94-0.3%11:08 AM EST

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To: Biomaven who wrote (4309)7/13/2001 10:57:22 PM
From: Biomaven  Read Replies (2) of 52153
 
FDA Letterhead

Dear [Pharma/Biotech]: (choose one)

We regret to inform you that your [NDA/BLA] is not approvable for the following reason(s):

- Application needs reformatting

- Application needs reformatting (again!)

- Subgroup analysis

- Safety concerns (ask Sidney Wolfe for details)

- It's already available in health food stores

- Factory is dirty

- We're waiting for the new Commissioner

- Vaguely related to abortion (you saw what happened to the last Commissioner!)

Yours Sincerely,

Acting FDA Commissioner.

We're doing our bit to keep America drug-free!
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