They didn’t give an extension they allowed a conversion to a Q submission. I’m sure FDA didn’t say it would be denied but given FDA has asked questions that Vivos felt they could properly address without more time, Koreneko saw the writing on the wall and pivoted.
Converting from IDE submission to Q is not common but also not unheard of. So we just proceed from here.
FDA didn't grant an extension. FDA allowed MK to withdraw application and return to pre-sub discussion program. The alternative was an FDA rejection of application. All MK's fault for not getting everything to FDA for feedback while in pre-sub. He's still messing with stuff that should have been put to bed many years ago. The guy is a gross incompetent.
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