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Thursday, 01/21/2021 3:49:34 AM

Thursday, January 21, 2021 3:49:34 AM

Post# of 181881
Chereb - Now I will agree with you there and share some of your concerns. Since we do not know exactly the conversation that took place it is hard to guess. For all we know MAYO was asked to support part of the submission with data and content and that is exactly what they did. I does suggest to me they either felt they had strong grounds to pursue this route and that they were somewhat surprised by the FDA decision. Either way the key here is that they did provide support and are on the team to get this over the finish line. I believe they will be great partners for the human trials piece when we get there to help shorten the process and bring all of their internal processes, best practices and accredidation to the collected data. Once they put their stamp of approval on the data for FDA submission it should go along way.
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