Add the FDA to the list of federal agencies who are on to MiMedx

Believe or don’t believe the channel stuffing allegations. We believe MDXG’s channel stuffing is significant, and we believe Petite Parker and friends are breaking the law.

Completely separate from the above, the FDA just put an Axe in MDXG’s forehead.

Today, FDA guidance was finalized that first came out in draft form in 3Q 2015. When the stock crashed to around $7, Petite Parker issued a press release to say:

In terms of the impact to MiMedx, we find the significant price decline in our stock today to be an overreaction of the market to this issue, likely because the market misunderstands the significance of the documents and the lengthy process that is involved in bringing matters to closure,” continued Petit. “What has been released by the FDA is an initial proposed draft, which is subject to modification as comments are received and testimony is submitted. Additionally, a determination will need to be made as to whether the process will involve rulemaking and legislative oversight, which will further extend the process.

On the call, Petite Parker continued,

Now I also want to follow up on the press release we sent out regarding the FDA’s guidance document agenda for 2017. Every year, they publish a calendar year guidance agenda — a calendar for the guidance agenda. This is a schedule that projects the release dates of guidance documents, both draft guidance as well as final guidance documents. The 2017 agenda did not include any reference to the minimum manipulation or homologous use of HCT/Ps. This was not a surprise to us as we’ve been told that the FDA received many thousands of comments; the vast majority of them taking issue with the draft guidance as proposed. So we’re very encouraged that the FDA is taking the time to carefully review the input. And based on the calendar it has published, we don’t expect any significant updates in this area for about a year or possibly more.

Another consideration that we think is very positive is that the people that are in the current consideration for the position of FDA Commissioner generally believe that new technology should be made available to the public once safety is assured, much like what was stated in the 21st Century Cures Act. So that gives us comfort that we are not likely to see something coming out of left field like the untitled letter or the draft guidance that’s coming — in the coming years.

So much for that.

Today’s significant update shows that comfort was completely misplaced. Don’t take our word for it. Just read MDXG’s risk disclosure in their 10-k:

FDA Untitled Letter and Draft Guidance

On August 28, 2013, the FDA issued an Untitled Letter alleging that the Company’s micronized allografts do not meet the criteria for regulation solely under Section 361 of the Public Health Service Act and that, as a result, the Company would need a biologics license to lawfully market those micronized products (the “Untitled Letter”). Since the issuance of the Untitled Letter, the Company has been in discussions with the FDA to communicate its disagreement with the FDA’s assertion that the Company’s micronized allografts are more than minimally manipulated. To date, the FDA has not changed its position that the Company’s micronized products are not eligible for marketing solely under Section 361 of the Public Health Service Act. The Company continues to market its micronized products but is also pursuing the Biologics License Application (“BLA”) process for certain of its micronized products.

On December 22, 2014, the FDA issued for comment “Draft Guidance for Industry and FDA Staff: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.” Essentially the Minimal Manipulation draft guidance takes the same position with respect to micronized amniotic tissue that it took in the Untitled Letter to MiMedx 16 months earlier. The Company submitted comments asserting that the Minimal Manipulation draft guidance represents agency action that goes far beyond the FDA’s statutory authority, is inconsistent with existing human cells, tissues, and cellular and tissue-based products (“HCT/P”) regulations and the FDA’s prior positions, and is internally inconsistent and scientifically unsound.

On October 28, 2015, the FDA issued for comment, “Draft Guidance for Industry and FDA Staff: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The Company submitted comments on this Homologous Use draft guidance as well. On September 12 and 13, 2016, the FDA held a public hearing to obtain input on the Homologous Use draft guidance and the previously released Minimal Manipulation draft guidance, as well as other recently issued guidance documents on HCT/Ps. The Company awaits further decision from the FDA on the draft guidances, but anticipates this will be a lengthy process.

If the FDA does allow the Company to continue to market a micronized form of its sheet allografts without a biologics license either prior to or after finalization of the draft guidance documents, it may impose conditions, such as labeling restrictions and compliance with current good manufacturing processes (“cGMP”). Although the Company is preparing for these requirements in connection with its pursuit of a BLA for certain of its micronized products, earlier compliance with these conditions requires significant additional time and cost investments by the Company. It is also possible that the FDA will not allow the Company to market any form of a micronized product without a biologics license even prior to finalization of the draft guidance documents and could even require the Company to recall its micronized products.

and

Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time- consuming and may impede our ability to fully exploit our technologies.
The process of obtaining regulatory clearances or approvals to market a biologic or medical device from the FDA or similar regulatory authorities outside of the United States is costly and time consuming, and there can be no assurance that such clearances or approvals will be granted on a timely basis, or at all. As discussed above, we intend to pursue approval of a Biologics License Application (BLA) for certain of our micronized products. Additionally, the FDA may take the position that some of the other products that we currently market require a BLA as well. Some of the future products and enhancements to our current products that we expect to develop and market may require marketing clearance or approval from the FDA. There can be no assurance, however, that clearance or approval will be granted with respect to any of our products or enhancements or that FDA review will not involve delays that would adversely affect our ability to market such products or enhancements. The process of obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources and may take years to complete. The fee for filing a BLA and the annual user fees payable with respect to any establishment that manufactures biologics and with respect to each approved product are substantial. Additionally, there are significant costs associated with clinical trials that cannot be estimated until the IND is approved. Moreover, data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. Like the process of obtaining an approved BLA, the process of obtaining a PMA requires the expenditure of substantial time, effort and financial resources and may take years to complete. The FDA may not grant approval on a timely basis, or at all. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.