Wednesday, March 31, 2021 9:01:52 AM
On March 3, 2021 we participated in a discussion with the Food & Drug Administration (“FDA”) regarding our Premarket Approval (“PMA”) application,
wherein the FDA requested supplemental information relating to our manufacturing procedures, including quality control related documentation. The FDA also
commented that the form and content of our clinical and non-clinical data has been evaluated and were satisfactory for them to complete their review process once
our application was finalized. We are collecting the requested information and incorporating these materials into our PMA application and will to resubmit to the
FDA once completed. There can be no assurance that our application, once revised and resubmitted, will lead to a successful FDA decision regarding a PMA
I have no idea what I am doing ... and I can prove it.
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