Replies to post #165762 on Biotech Values

[DewDiligence]

Pradaxa meets primary endpoint in phase-3 trial for acute VTE treatment:

http://finance.yahoo.com/news/phase-iii-study-dabigatran-etexilate-130000437.html

This is the first time detailed data have been released on this trial; however, the trial’s success was no secret insofar as the FDA is currently reviewing B-I’s sNDA to expand Pradaxa’s label to this indication (#msg-91483454).

[DewDiligence]

FDA approves Pradaxa for VTE treatment and secondary prevention:

http://finance.yahoo.com/news/fda-approves-pradaxa-dabigatran-etexilate-123500776.html

The label’s VTE treatment indication specifies that Pradaxa may be given after 5-10 days on an injected anticoagulant (usually Lovenox).

The European MAA for Pradaxa in the above indications was submitted on 6/24/13 (#msg-89322704) and is under review.

Competition: Xarelto is already approved for the VTE treatment/secondary prevention indication in the US (#msg-81103054) and EU (#msg-80711606); Eliquis has a US PDUFA date of 8/25/14 for this indication.