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dewophile

12/01/10 5:05 PM

#109692 RE: DewDiligence #109682

re m118 dosing in future trials

given the size and scope of development i would expect some additional dose-finding. however, based on the eminence data, it looks like you may still be on the steep portion of dose-response curve between 50 and 75, and the safety on 75 was good. whether or not you get any additional efficacy on 100 vs 75 is unclear (and perhaps unlikely based on the data although in another pt population you never know). so imo if you were limited to taking 2 doses forward i would pick the 75 and 100 over the 50. of course the nature of the trial may guide dosing too - e.g. superiority on primary endpoint might lean towards pushing dose higher, non-inferiority vs angiomax which bests heparin on bleeding might lean towards lower dosing and sacrifice perhaps some efficacy for safety (bleeding)
jmo