Replies to post #142323 on Biotech Values

[DewDiligence]

Nice call—Xarelto looks like a good bet for approval in ACS at the lower dose (according to the FDA briefing docs at #msg-75808358). Still, I find it curious that JNJ submitted a standalone sNDA for Xarelto in the PCI component of ACS (#msg-75391993), and I wonder if the FDA ought to review the two Xarelto ACS submissions together and whether the advisory panel will opine on this question.

[DewDiligence]

Advisory panel rejects Xarelto for ACS by 6-4 vote:

http://in.reuters.com/article/2012/05/23/us-fda-jj-idINBRE84M1EH20120523

…the panel said Xarelto looked promising but missing data could skew results. [The FDA commented on missing data in its briefing docs, although the FDA reveiewer nevertheless stated that Xarelto should be approved.] They were also concerned about bleeding risks.

"I want to see better evidence that this strategy of adding (Xarelto) ...is robustly better for the patient," said Dr. Steven Nissen, panel member and chairman of cardiovascular medicine at the Cleveland Clinic. "And I just wasn't convinced."

Having Dr. Nissen opposing your drug on a panel of this nature is almost like stepping up to home plate with a count of two strikes.

p.s. My contention in #msg-69172520 that Xarelto will have no effect on the US Lovenox market in the ACS indication appears to be safe for now.