Replies to post #800 on Galectin Therapeutics Inc. (GALT)

[Darwinian]

Good question.

I found this:
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

No specific timetable, but interesting to read. It appears that having fastrack designation does allow them to apply for priority review and accelerated approval. I suppose I could see that happening with GR-MD-02 with a bit more concrete data. Though, phase 1 cohort numbers are small. I wonder if they'd want to see this perform in larger groups first?

By the way, good to see you here. I think I may know you from another forum. I may send you a private message through that forum.

Best to you.

[bradfor123]

Phase 1 , 2 and 3 I think if all goes well and best case scenario would be 5 years

[BelizeBeachTrader]

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.