Followers | 3183 |
Posts | 208744 |
Boards Moderated | 2 |
Alias Born | 02/04/2004 |
Monday, September 19, 2016 2:38:42 PM
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
Recent IPCI News
- Suspension de la négociation par l'Organisme canadien de réglementation des investissements - IPCI • PR Newswire (Canada) • 03/06/2024 12:55:00 PM
- Canadian Investment Regulatory Organization Trading Halt - IPCI • PR Newswire (Canada) • 03/06/2024 12:51:00 PM
- L'Organisme canadien de réglementation des investissements permet la reprise de la négociation - IPCI • PR Newswire (Canada) • 06/08/2023 05:30:00 PM
- Canadian Investment Regulatory Organization Trade Resumption - IPCI • PR Newswire (Canada) • 06/08/2023 05:28:00 PM
- Intellipharmaceutics Announces Fiscal Year 2022 and First Quarter 2023 Results • PR Newswire (Canada) • 06/06/2023 10:00:00 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM