MARIETTA, Ga., Oct. 28, 2013 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company concluded a productive meeting with the Food and Drug Administration ("FDA") earlier today, October 28, 2013.
Parker H. Petit, Chairman and CEO, said, "We were pleased to have had the opportunity to present to the FDA our basis for concluding that our micronized products are minimally manipulated and meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 of the FDA's regulations. The FDA acknowledged that our presentation included new information that they would review and consider, and they committed to responding in a timely fashion. We hope that, upon further analysis, the FDA will agree with our position. In all events, we are committed to continuing to work with the Agency to agree on a regulatory solution to ensure that our micronized products are available for patients who can benefit from their clinical effectiveness. These solutions could include, among other things, one or more of the following: labeling changes, changes to the product, changes to the process, or submission of a Biologics License Application."
The problem with today's meeting is that there was expectation of something definitive and positive being reported.
My post of 10/17 -
"I'm repeating myself but I don't expect to hear anything positive or negative from this meeting until months later. Based on our timeline with the FDA, it could be sometime in the Q1 or later before they respond to the company."
My post of 10/10 -
"I know we're both just spit balling here but I don't see the FDA telling our boys immediately "you're right, we're wrong". They don't generally work that way which leaves Petit et al leaving the meeting with the announcement that they've had a productive meeting and the FDA might change their mind. All to say, I don't think anything definitive will be announced next week if (delayed until 10/28) there's the scheduled meeting.
nice call however one thing you did not spot was ..."The FDA acknowledged that our presentation included new information that they would review and consider, and they committed to responding in a timely fashion".
Clearly the FDA did not do it's job and MDXG had to educate them.
I see comments from the FDA within the next week and additionally positive color from management on the cc tomorrow. JMHO