Replies to post #16877 on Intellipharmaceutics International Inc. (IPCI)

[mopar44o]

Which one?

[wimuskyfisherman]

ELTP holder- IPCI has worked out a deal with the FDA that they will not need to do a PH3 if they can show bioequivalence. The bottom line is their NDA will attempt to show this bioequivalence. If not, they will need to do a PH 3. IPCI PRs claim they have shown this bioequivalence. I guess it is just wait and see at this point. One other thing worth noting is IPCI issued a PR that Rexista has no food effect. Something ELTP cannot claim. And since you are here... How is the ELTP CRL going? It is my understanding the CRL has to do with food effect...