Biotech Values

[walldiver]

<<Did the Tarceva trials you cited have an SPA?>>

I don't think so.

<<To obtain near assurance of FDA approval if the specified conditions are met, a sponsor seeking an SPA generally has to agree to more stringent requirements than what might be possible without an SPA.>>

True, but in GTOP's case I believe the cumulative p value threshold is much too stringent for this to be the only reason. It could be that it's one factor, with the progression endpoint being the other.