Thursday, March 14, 2019 3:10:54 PM
Thus, if 500 patients needed overall, you could have 300 in EU and 200 in USA and the total of 500 satisfies the total requirement of each trial. Cost savings since total patient enrollment for both trials combined is 500, not 1000 as would be needed if P3 didn't meet each regulatory body requirements.
Note that attaining a P3 allowance is usually a milestone. Now that we know we will have a USA/EU P3 that milestone has been met so those monies move over to the upfront payment of the deal.
Such added monies could help Leo dicker a bit further to get a more lucrative IBD deal, use for operational costs, or further pill formulation for IBD and K. Always helps to have some extra cash in the bank.
As to BTD for OM, why has it been declared dead or failed by noteworthy naysayers? Who has any clue if it was ever submitted? Maybe that is something still to be forthcoming as P3 will incorporate both a high dosage and low dosage cisplatin arm and company has designed P3 to achieve even better results in both arms so that BTD could be submitted and received during the P3? Just saying nobody knows for sure, but making declarative statements that it is dead is plain hogwash.
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM