Replies to post #114677 on Biotech Values

[DewDiligence]

PLX/PFE get CRL for Gaucher drug:

http://finance.yahoo.com/news/FDA-Issues-Complete-Response-prnews-3210672532.html?x=0&.v=1

The main questions raised by the FDA regarding the NDA relate to clinical and chemistry, manufacturing and controls (CMC). In the clinical section, the FDA requested additional data from the Company's switchover trial and long-term extension trial. At the time the NDA was submitted, full data from these trials was not available. In the CMC section, the FDA requested information regarding testing specifications and assay validation.

CC today at 8am ET.