Friday, October 18, 2019 8:48:58 PM
From all my years as an executive in pharma, I look at this trial from a purely clinical standpoint. I’ve studied thousands of clinical trials in my career and everything about the trial and results says FDA approval to me.
1. Quality of the investigators
2. Study design:
- WIRB
- patient selection
- head to head vs. SurgiCel (current standard of care
- positive outcomes on primary and secondary endpoints including non-inferiority AND superiority.
Folks, it doesn’t get any better than this. HemoStyp WILL get the class 3 approval. I couldn’t be more certain of that outcome!
We will all be celebrating for a very long time!
Cheers and have a great weekend friends!
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