Replies to post #93801 on Biotech Values

[mcbio]

Re: MNTA/M118

Your first sentence is incorrect—in the primary efficacy endpoint of the EMINENCE study, lower numbers are better; thus, the EMINENCE study did not find a relationship between dose and efficacy.

Ah, my bad. Thanks for the clarification. I'll admit I wasn't 100% sure when I read the language regarding the primary endpoints so I just assumed higher was better and that there was a clear dose-response relationship.

Is it safe to assume that M118 need not necessarily demonstrate superiority to UFH (or LMWH, Angiomax, etc.) in future trials and that non-inferiority may be sufficient for the drug to be a commercial success given all of the advantages of M118 compared to UFH, LMWH, and Angiomax that you've noted in #msg-39146357? I.e., even if superiority is not demonstrated on efficacy endpoints, I assume this will be a much easier drug to administer which could be a big advantage. I do imagine cost considerations would come into play, though, if efficacy were non-inferior and not superior.