Replies to post #12971 on Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Two Rexistas? Unpossible!

Yes it's confirmed that there's going to be 2 versions of Rexista...the 1st one which has already been fast tracked is the original potential best-in-class version incorporating their npodds tech...which IPCI is currently doing the bioequivalence on for submission to the FDA most likely during Q1 2016 which will be the 7 to 9 month mark from when they received the go ahead from the FDA to skip phase III entirely.

Glad to see this truth finally being endorsed by the company and recognized by this board. This post is incorrect, however; the original Rexista is not fast-tracked. Rexista with PODRAS is fast-tracked. Please let me know if I can be of any assistance in the future.

2 Aug 2015:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115888966

I think the better question to ask IPCI is if they are developing two different Rexista formulations. For the sake of differentiation, let’s refer to them as Rexista Legacy and Rexista PODRAS. Rexista Legacy is a mechanical barrier ADF 12 hour oxycodone formula with successful Phase 1 results and is likely undergoing Human Abuse Liabilty studies at this time. The company says it has been informed by FDA that Rexista Legacy may be able to skip Phase 3 and therefore will be ready for NDA submission within 6-12 months. The company would use revenue from FDA-approved Rexista Legacy as a non-dilutive source of funding to research and develop Rexista PODRAS, an augmented formulation of Rexista Legacy in which preclinical studies suggest it could possibly reduce oral abuse and may prevent oral overdose. Due to this unique characteristic, Rexista PODRAS fulfills an unmet medical need and was granted Fast Track status by FDA.

[umiak]

Excellent double the fun!