Biotech Values

[mcbio]

The trial isn't powered nor designed to show superiority. Antibiotics are approved on non-inferiority. Anything in the ballpark and no unknown safety signals are the bar at this stage of the game.

The trial also did not stratify for MRSA/MSSA between arms so inter-arm variability may have to do with different disease to a greater degree than drug.

David, caught your questions during Q&A of the PYMX call. Were you a bit bothered that management wouldn't divulge the efficacy numbers per arm even though they have them? I guess maybe the concern is 3 arms have 87% cure rate and 1 arm has a 100% cure rate making it likely obvious which arms are the 30063 arms and which was the Cubicin. But, I guess that's not likely given what we know from Cubicin's label.

Also, do you have any issues with them receiving the data directly from the CRO? In your questions, you seemed to have some concern that they could have inadvertently unblinded the data given the manner they received it (thinking perhaps you may have had an issue that they received the clinical cure rates for each arm).