Biotech Values

[poorgradstudent]

SRPT:

I think it is safe to say that they either do not have valid biopsies they thought they did, or the FDA didn't like the resulting WB analysis (I purposely left out the possibility that SRPT didn't like it because, realistically, SRPT likes any and all data via post hoc 'reasoning' - aka excuses).

They had already used a few of the biopsies from patients in this trial as part of their submission prior to the panel. I wonder if they're trying to mix and match some pre- and post- samples again if they've run out of one or two samples along the way.

One other possibility is the FDA is going to approve regardless of results, and has asked SRPT not to explicitly mention submission of the WB data. I do think if SRPT acknowledges it, then it is material and would have to be disclosed... and if the data are poor (as I expect), the FDA doesn't want a public paper trail of how they've been accepting poor data at every step of this submission. This scenario would also be consistent with some FDA employees being dissatisfied with the way the SRPT submission has been handled (provided the WSJ article was accurate).