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Re: kayak_wench post# 168841

Thursday, 12/21/2023 3:45:21 AM

Thursday, December 21, 2023 3:45:21 AM

Post# of 175931
Congrats to us and all that endured a very lengthy saga to get to this point.

Today's news at this particular time came as quite surprise .

So reading this paragraph I'm wondering if the Genotoxicty data along with final 9 rabbits were already submitted to the FDA

Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness.

I'm thinking we ready to roll with submission.

Now I believe we all can relax as IDE approval is 100% in the bag no doubts and very soon
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