Spot on! Not that it needs any more elaboration but what the heck, its Friday.
Paul's words were "we will be submitting a complete response to a type D meeting that we had with the FDA, which is answering any questions that they have from the data they've seen"
A Complete Response Letter (CRL) is a notice issued by the FDA to a sponsor that the application wont be approved (ususally with a clinical hold). So, completely the otherway around! And yes announceable of course.
Oh, and the bit about Type D meeting, well, "narrow set of issues", "timely feedback" and "moving the program forward"....all sounds pretty good to me.
Ann: PAR to present at NWR Healthcare Conference, page-50
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