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SC8

01/26/24 7:10 AM

#170220 RE: doccjc #170214

How is MK "doing everything to assure an APPROVAL" when he waited until 2021 to enter FDA's pre-sub program and then wasted two more years resisting FDA suggestion for the controlled rabbit testing that remains ongoing? Why did he wait over a year to respond to FDA comments from first meeting? It was in reviewing those responses that FDA flagged the genotoxicity omission, and here we are a year later and MK is still messing with that too. His biggest failure time wise was not wrapping this up many years ago when they still had patent protection. That weak process patent he crows about isn't even a fig leaf of coverage vs. what the now expired patents would have provided.

mc73

01/27/24 9:29 AM

#170281 RE: doccjc #170214

True - we need approval of IDE. What I'm saying is share price is essentially stuck until we submit the IDE and all these thing the cheerleaders keep posting ad nauseum are meaningless as far as share price.

Don't get me wrong, I'm happy with each step forward, but it sure seems like the communication between RDGL and FDA isn't very good. We should have a road map of all testing required and a timeline of when the required tests will be complete and an estimate of when we submit the IDE. So far, it has been test, meet with FDA, more tests....repeat.