MiMedx (MDXG) responds to an FDA letter which sent the shares tumbling 36% during the regular session.
The FDA says the company's Amnion / Chorion Injectable products "are not regulated solely under section 361 of the Public Health Service Act" and in order to market them, the company needs a "valid biologics license." Because "none of the ... products ... are the subject of an approved biologics license application, nor are there INDs in effect for any of these products, [the FDA] has determined that [the company's] actions have violated the Act." (full letter)
For its part, the company is "surprised" and says an inspector from the FDA advised it that the Center for Biologics Evaluation and Research "had completed its review and had no findings or further questions and, therefore, the  inspection was classified as No Action Indicated." MDXG says a copy of the report establishing NAI is available on its website. (PR)
MDXG +9% AH.