Replies to post #122939 on Biotech Values

[DewDiligence]

(REGN)—SNY withdraws Zaltrap BLA due to CMC problem:

http://www.sec.gov/Archives/edgar/data/872589/000120677411002936/regeneron_8k.htm

Regeneron was informed by Sanofi that on December 19, 2011, Sanofi voluntarily withdrew, and plans to re-submit in early 2012, the Biologics License Application (BLA) it submitted to the U.S. Food and Drug Administration (FDA) for marketing approval of ZALTRAP® (aflibercept) in previously treated metastatic colorectal cancer. The withdrawal was based upon comments from the FDA on the Chemistry, Manufacturing and Controls section of the BLA…

REGN did not have the decency to issue a PR for this.