Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

Samsa, working on alternate Rexista_product_candidate incorporating PODRAS. So IPCI is using words like "incorporating" and "prototypes" suggests that PODRAS is probably not in current formulation.

From 3rd quarter 2016 management discussion, it says, "We are currently working on an alternate Rexista® product candidate incorporating our PODRAS™ delivery technology." And IPCI did "Preclinical studies of prototypes of oxycodone with PODRAS technology". Also, from the patent document, it labels the PODRAS version as type ODR, or type overdose resistant.

Assuming PODRAS is not in current formulation, sNDA (supplementa NDA) filing will depend on whether PODRAS changes bioquivalence. Presentation says when 1 or 2 pills are taken, drug release should be as expected. So maybe PODRAS does not change bioequivalence.

Samsa wrote: "Angelo.....your making an assumption the formula needs to be changed. what if the formula doesn't need to be changed? at which point all you need to do is the supplemental phase 3 trials to prove the label change and indication."