Probably not related to EU news. SNTS sent the new data to FDA on Aug 3 and FDA accepted on Aug 10. The EU news was Aug 9th, but who knows. This is a CMC issue for the news released today and the EU had to do with clinical relevance.
Listen, the fact that SNTS could send in something that was requested by the FDA is a good sign, Aug 3rd before it got too close to PDUFA. It is probably some inspection data or something regarding manufacturing. You either have data you can submit or you don't. So, I can't see it as a big problem. If they had to run new experiments, then we would be facing a much longer delay.
The part that I see as interesting is:
"The FDA also indicated that if major deficiencies are not identified during the review of the NDA, the FDA plans to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests to Santarus by December 12, 2012. Assuming FDA approval, Santarus anticipates that it will be in a position to commence the launch of UCERIS approximately two months following the determination of the final product label."
I don't think I have ever seen labeling come before PDUFA decision. Release of labeling early, means nothing is wrong in the clinical section, and thus approved.
Anyone else think this is significant wording or have you seen any situation like this? TIA