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Tuesday, 05/17/2022 2:36:46 PM

Tuesday, May 17, 2022 2:36:46 PM

Post# of 172121
Not a big hurdle IMO. They have access to many different cases with all of their regional clinics now unlike years ago when it was a few a year if they were lucky. They also have access to test animals like the rabbits and or rats they did a lot of their studies on.

I could see the FDA wants to have more than one or two studies showing the gel holds everything into place as this is one of the biggest parts that could go wrong if it were to. Again half of Friday's discussion is good to go per the FDA and the topic has a easy, quick fix if they end up requesting more tests/data. Not concerned and they were quick to keep us in the loops like everyone wanted. Very happy even though there may be a small set back if you can even call it that.

They are clearly doing the right thing and are on the right path for the best chance of moving forward. Very exciting times.
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