Galectin Therapeutics Inc. (GALT): After any review the FDA can grant appro...

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Galectin Therapeutics Inc. (GALT)

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Re: pugdaddy post# 800

Wednesday, 04/02/2014 2:09:58 PM

Wednesday, April 02, 2014 2:09:58 PM

After any review the FDA can grant approval under fast track. The company is still required to complete all phases. If there is a failure along the way the approval can be pulled. Many times approval is given for compassionate use only. About 50% of the drugs that get approval under fast track get it after the first review. This typically occurs in Phase2. It is very rare for a drug to receive fast track in phase1.
So the first review of phase2 would seem to be the earliest but since GALT has fast track now anything is possible if the FDA likes what they see.

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