Sunday, March 17, 2024 4:32:18 PM
If it were up to me, at least in drug approvals, at the end of a trial the regulators could sit down with the DSMB and clinicians, if they like what they see and discuss, they could make an instantaneous decision to approve. That would eliminate the need for million page applications and save years of time, and millions of dollars being spent. I'm certainly not speaking about just our trial, I'm thinking of almost every product I felt certain would be approved, and ultimately was. If with no medical background I could be that certain, I can't believe the regulators, clinicians, and DSMB couldn't come to the same conclusion without years of additional efforts.
I suspect the same can be said of the Judge in our legal case, he may not know precisely, but I suspect that if all the key players got together it could be resolved far faster, but that's not how things are done, so they'll play with all the means of delaying a decision.
Gary
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