Biotech Values

[DewDiligence]

FDA issues CRL for BMY’s Daclatasvir for the simple reason that it doesn’t work as monotherapy:

http://finance.yahoo.com/news/bristol-myers-squibb-receives-complete-163400129.html

The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October [#msg-106957091], the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.

Notably, this PR makes no mention of BMY’s plans to submit an NDA for the DCV-TRIO regimen in 2015 (#msg-107987450), suggesting to me that there are no such plans.