RE:RE:RE:RE:RE:Sanofi delays BCG production to mid 2016...M80, i wonder if pharmaguy (????) can chime in, he is the poster who consults to pharma and has experience in FDA approvals, but as i understand the FDA has a formal 550 point evaluation process, most of which is internal to the proponent (clinical data, CMC, etc.)...but i believe Adcom is considered as are cancer advocates/patients and i believe state of access to care is also considered (ie BCG availability)..i believe in the Adcom it was referenced that while Adcom is specific to the Questions posed by the FDA that the FDA has the right and obligation to consider all factors in making its decision..but always with the proviso that drugs considered unsafe will never be approved...so i am unsure how the FDA formally considers ancillarly data but i believe they do...
..pharmaguy what is your thinking???