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DR5

11/10/18 11:21 AM

#1733 RE: Chrism0000 #1732

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.

rodman

11/10/18 1:09 PM

#1734 RE: Chrism0000 #1732

Yes and no estimated primary 11/19 and final looks like 12/3. Hopefully the company will advise soon.

https://clinicaltrials.gov/ct2/show/NCT03654560