Biotech Values

[oldberkeley]

Questions for the board: I'm doing some DD on Aastrom Biosciences (NASDAQ: ASTM).

After an interview with execs at the JPM Healthcare Conf., Jason Napodano wrote (bolding mine):

I do not think we will see Aastrom change any of the inclusion/exclusion criteria for REVIVE. This is an incredibly well-designed program with significant feedback (special protocol assessment) from the FDA. Aastrom does not want to stray from its SPA agreement. However, what I think we will be seeing Aastrom do throughout the next few months is changing the lexicon around the inclusion/exclusion criteria. For example, instead of calling it “critical limb ischemia”, we may start hearing more “severe peripheral artery disease,” or instead of using the term “Rutherford-5", we may start hearing more “confirmed tissue loss.” These are the same patients, but with a more widely acceptable or obvious classification.

1. Why do it/what's the advantage in doing this?
2. Given the number of biotechs that have “moved the goalposts” during or after testing, is this an example of that? If so, how would it be viewed by the FDA?

TIA.