I spoke to AI who tells me "An FDA Deficiency Letter is a communication sent by the U.S. Food and Drug Administration (FDA) to an applicant during the scientific review process. When the FDA identifies discrepancies or deficiencies in a product application, they issue this letter to request additional information. It’s not meant to list concerns about the product but rather to inform the applicant of identified deficiencies." I am not concerned that Brian Thom and his team cannot adequately reply but the timeline certainly is aggravating but the efficacy of the product is not concerning to me. Sterilization testing data should provide some information with regard to shelf life IMO! The FDA clock has been paused and is encouraging and also a positive sentiment IMO.
"We are very pleased to have reached this milestone in the PMA process, and to understand the FDAs assessment of our application. We are confident we can address these deficiencies to the FDAs satisfaction. In the coming weeks the company will be engaging with the FDA review team directly to determine the most efficient path to providing our responses."
$5-$10+