Copied this from the trial outline:
Estimated Study Start Date : September 6, 2018
Estimated Primary Completion Date : November 19, 2018
Estimated Study Completion Date : December 3, 2018
I interpret this to mean that ~ 11/19 the Non-inferiority of HemoStyp versus Surgicel is the primary endpoint date. Secondary endpoints and “superiority” evaluations continue to 12/3.
I’d say give them till the end of December to send the package to the FDA for review.