RE: Rationale behind decision..3 May 2022 20:10
Jatw, yes, agreed there has been a shift in what is accepted and what's not, this is referenced many times during the web cast by various participant's.
Oddly enough, I see a small positive in that the only reason for rejection was based on data demographics and factory access, if had been due to under performance of the drug itself that would be entirely different.
Hopefully they can put repeat the same design study using US population , fresco2, global phase 11 trial is already mrct.