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Re: DaubersUP post# 258204

Thursday, 03/14/2019 3:10:54 PM

Thursday, March 14, 2019 3:10:54 PM

Post# of 403047
One of the biggest cost savers is that since the P3 will be run according to all the specifications of BOTH the FDA and EMA the patients in one P3 can be counted as being in the other P3.

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.
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