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Friday, June 30, 2023 9:13:46 AM
‘…The testing of additional batch lots of Hemostyp returned favorable results indicating that Hemostyp is manufactured, packaged and shipped with specs identical to those in the human trials. These results have been incorporated into the PMA application, which is now complete, and the full application will be submitted to the FDA.
We have alerted the FDA of our intentions and expect to have confirmation within 30 days that the PMA application has been accepted and put forward for substantive review…’
If this is not the case, hopefully they are clear and to the point with what the future holds for Hemostyp and the next steps in the process.
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