This NDA, which is separate from the rejected Xarelto NDA in ACS per se, was voluntarily withdrawn by JNJ in July 2012 (#msg-77346396). In today’s PR, JNJ confirms that the additional information in the resubmission for PCI is in response to questions raised by the FDA in the June CRL rejecting the NDA in ACS (#msg-76856261).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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