FDA refuse to file letter

A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis
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bee26
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Joined: Tue Jan 12, 2010 3:00 pm

FDA refuse to file letter

Post by bee26 »

The FDA have sent Genzyme/Sanofi a refuse to file letter. They're not asking for more trials, just for more info at the moment, but it will put back approval in the US by another 6 months or so. The EMA in Europe have accepted the application.
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