Replies to post #144400 on Biotech Values

[DewDiligence]

The Eliquis CRL sounds fixable in a relatively short time; from BMY/PFE’s joint PR:

http://www.marketwatch.com/story/bristol-myers-squibb-and-pfizer-receive-complete-response-letter-from-us-food-and-drug-administration-for-eliquisr-apixaban-2012-06-25

The CRL requests additional information on data management and verification from the ARISTOTLE trial [this is the study that tested Elqiuis vs warfarin; the FDA has asked no questions about the AVERROES study that tested Eliquis vs aspirin].

Bristol-Myers Squibb and Pfizer will work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.