Biotech Values

[DewDiligence]

Bayer says reply to FDA’s CRL for Xarelto will not come until 2H10:

http://www.reuters.com/article/idCNLDE61P0AM20100226

Bayer’s US partner, JNJ, had recently declined to offer any guidance as to when the reply to the CRL would be submitted (#msg-38200098). The FDA issued the CRL way back in May 2009, so evidently Bayer/JNJ have a lot of work to do to satisfy the FDA’s concerns.

The Xarelto delay is a break for the other companies vying for this market—see #msg-47110236.