It's not what you are thinking...
While he did say "Complete Response" the context was "...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 have seen".
This indicates PAR will provide a plethora of data including but not limited to 008 data as well as safety data and drug efficacies.
Imagine how much new stuff there is since our last IND chat....There is a stack there to compile and submit.This will no doubt take some time.Yes he prob should've said "Full response" as the company is not on clinical hold and this is not a 'Complete Response' that the FDA has issued.
My thoughts
Ann: PAR to present at NWR Healthcare Conference, page-17
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