Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

When will IPCI stop pretending...


...that Rexista with PODRAS will skip Phase 3 and be ready for submission in 6-12 months???



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.