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Re: chereb19 post# 146850

Tuesday, 05/17/2022 1:48:33 PM

Tuesday, May 17, 2022 1:48:33 PM

Post# of 172899
Doesn't sound like something FDA asked. Sounds like something MK is anticipating they may ask, and that's what makes it a dumb tweet. He's inviting FDA to ask for another test they haven't asked for. Will add, I'd be surprised MK doesn't already have this data from prior recipe, but he's anticipating FDA may ask for repeat with new polymer process just like was required with bio-compatibility testing that had to be repeated. No details like that should be public at this point, as only opinions that matter are those of the FDA reviewers. Public opinion is irrelevant to getting IDE application approved.
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