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Re: doccjc post# 161997

Saturday, 05/27/2023 4:05:32 AM

Saturday, May 27, 2023 4:05:32 AM

Post# of 180777
Gotta keep it real.

How does approval come within two months (by end of July), when as of end April, MK hadn't bothered to write up and submit the rabbit tumor containment results, the rabbit dosimetry study remains on going and he has to respond to the comments on 2nd draft IDE application?

Then FDA will need time to review and comment on those submissions. Even if no further meetings are needed, it's hard to see an IDE submission by end of July, let alone an approval, which will likely take the full 30 day consideration period.
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