Replies to post #109681 on Biotech Values

[DewDiligence]

Bleeding incidents always have to be addressed in clinical trials of anticoagulants, but I’m expecting that, in phase-2b, bleeding will be will addressed via a distinct safety endpoint rather than as part of the (less precise) efficacy/safety composite endpoint that was used in EMINENCE.

Even if you take the (reasonable, IMO) position that the 50 IU/kg dose in EMINENCE was not better than the other two doses because the lower event rate for the primary endpoint stemmed from fewer incidents of minor bleeding, you can’t say that the 50 IU/kg dose was worse than the other doses in terms of both efficacy and safety. So I will be surprised if the 50 IU/kg dose is not one of the doses to be tested in phase-2b.

[DewDiligence]

Do you have any comments on the phase-2b patient pool (stable angina vs unstable angina vs NSTEMI vs STEMI)?

With adequate funding, the best approach would seem to be one phase-2b trial each for unstable angina/NSTEMI and STEMI, especially if the comparator is Angiomax. Such stratification could be important from a mathematical standpoint by enabling the trials to have less statistical noise, and it could be important from a business standpoint because Angiomax usage varies considerably among the sub-indications of ACS.