Replies to post #11657 on FDA Plays

[pcrutch]

CLDA was an NDA and those have 10 month or 6 month reviews. IPCI could really hear back anytime soon. I think the 17 months average is b/c some are generics of very complex drugs that the FDA wants time to review. Remember, most ANDA's dont have to supply data from Phase 3 trials.

I am definitely hearing that news flow is expected this year on their ANDAs, but dont take that as a guarantee. You never know with the FDA