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Re: manibiotech post# 649238

Tuesday, 11/21/2023 10:30:06 AM

Tuesday, November 21, 2023 10:30:06 AM

Post# of 705240
I have been saying this since spring when they didn’t submit immediately in the weeks following MIA in March. They had 30 months post data lock to prepare for the application already then and it was supposedly their number 1, 2, and 3 priority.

Having submitted multiple class II and III neurology medical devices through FDA and European regulatory agencies through my team, I know regulatory applications don't take this long regardless of how big or small your team is. Its the reimbursements that take forever but that is separate and we are not even discussing that yet!
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