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maumar

09/17/19 11:51 AM

#5678 RE: Fred Kadiddlehopper #5677

But usually the FDA accepts filings within 60 days. It looks like it was not rejected but there will be a (hopefully) slight delay.

maumar

10/04/19 10:24 AM

#5682 RE: Fred Kadiddlehopper #5677

I listened to the cc yesterday. If the SC Darzalex filing had been rejected or delayed, I would think Helen would know and would have had to say something. So perhaps it was accepted but neither Janssen nor Halo had a PR, which is unusual, I think.