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Re: InTheTrenches post# 87229

Wednesday, 12/09/2009 8:10:55 PM

Wednesday, December 09, 2009 8:10:55 PM

Post# of 257251
MNTA:

Maybe they do intend to go alone on M-118? Or at least posture that way for negotiations.

I seriously doubt that for the reason you cited: cost.

What is the estimate on how much it would cost to run a phase 2b and phase 3 on M-118?

The short answer is: too much for MNTA to afford on its own, assuming that the point of the trial is to measure adverse clinical outcomes over a meaningful period of time for patients randomized to M118 or an active control regimen.

Thanks to the wonders of modern medicine, ACS trials that seek to show superiority or non-inferiority in clinical outcomes have to be very large because the overwhelming majority of patients in all trial arms will do OK.


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