Biotech Values

[DewDiligence]

FDA issues Refusal-to-File Letter for SNY’s Lemtrada:

http://en.sanofi.com/Images/31059_20120827_LEMTRADA_FDA_FILING_EN.pdf

After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible.

Sounds easily fixable, but the RTF will push the review of the resubmitted BLA past the original PDUFA date of 4/12/13.