Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

In case anyone else is not clear on the Rexista Fast Track designation, here is an exchange between myself and Della Penna.

I am aware that Rexista with PODRAS has fast track designation - but I'm a little unclear if Rexista PODDS which you will be filing an NDA for soon has been granted fast track designation by the FDA.

his response.

Angelo, thanks for your email. You are correct, it is unclear. PODRAS has Fast Track status, but we believe what we are filing in August will have “Priority” status, similar to what Collegium, Elite and Pain T. received given the ADF properties and the need to address the opioid epidemic. If they granted the other’s priority status, they should grant same to us … especially given we have zero Food Effect which the others can’t claim!

my guess is that they will receive Priority Status... considering how eager the FDA seems to have been to get this out there.