well......in retrospect to the safety of the drug, the admission of stat sig in the crl, ACOG, HSS, AET, UNH, state of mich infant mortality plan, medicade, the fact thats its on the market, its incredible to me that the FDA was an unwilling participant. I dont understand it, and since I dont have access to the FDA who are making these calls, I wont get any clarity to that decision. Science has lost, high risk pregnancy has lost, stakeholders have lost and that is that.
I don;t buy it. FDA is not intentionally holding back because he said she said...There is something missing in data that the FDA is worried about and they have held it up. CBRX is a one trick pony and we are on a unguided ride to the glue factory. It sucks but its real. I am try to find a contra view here but I can;t .