Just like a redo of work already performed FDA is once again doing their substantive review. That has already been performed.
https://www.globenewswire.com/news-release/20...pdate.html
Like a learning curve FDA knows the company and the prior work performed like an audit!
12-22-21
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States.
Approval within 45 days!
$5-$10++
https://www.globenewswire.com/news-release/20...pdate.html
Like a learning curve FDA knows the company and the prior work performed like an audit!
12-22-21
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States.
Approval within 45 days!
$5-$10++