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doogdilinger

09/19/16 11:31 AM

#17774 RE: AngeloFoca #17773

I will definitely clarify that for us as well if I can, thanks Angelo
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doogdilinger

09/19/16 2:38 PM

#17796 RE: AngeloFoca #17773

Ok after a call to IR in regards to their Rexista PODRAS enhancement here's what we know...

1. IPCI can in fact file a supplemental NDA to Rexista version 1 if they so choose or...

2. IPCI can decide to file a separate NDA on Rexista version 2 with PODRAS.

At this point which exact route they plan on taking is contingent on several ongoing moving parts behind the scenes these days. Considerations such as overall commercialization strategy for PODRAS, lucrativeness of any potential partner suitors pertaining to Rexista versus Rexista with PODRAS etc etc etc

PODRAS will definitely require extensive proof of concept and Phase 1 studies...and any Phase III trial requirements will be completely contingent on the success/results of Phase 1.

Also, because the PODRAS tech can also be implemented into Tylenol, Acetaminophen and all other over the counter pain killers...there's obviously a ton of moving parts in play these days worthy of strong consideration behind the scenes as to exactly which direction they take PODRAS over the coming weeks/months...but suffice to say they're very pleased that their Rexista NDA submission and PODRAS patent approval continue to both be on the near term horizon which will put a lot of the recent speculation to rest.

So in summary the answer is "both" as to whether or not IPCI can simply file an NDA-S with the PODRAS enhancement or file a separate NDA on the PODRAS enhancement glta