>MNTA – another interesting take-away from the CC was that there is no "approvable letter" issued in ANDA's. So while the FDA response is in the form of a "not approvable letter" the requests for additional information on immunogenicity is similar to requests received in "approvable letters"<
The market hasn’t figured this out yet.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”