MiMedx slips as FDA reaffirms position on Axiofill [Seeking Alpha]
MiMedx Group, Inc (MDXG)
Last mimedx group, inc earnings: 4/28 07:00 am
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US:NASDAQ Investor Relations:
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Source: Seeking Alpha
Food and Drug Administration (FDA) reaffirmed that the company's placenta-derived wound treatment, Axiofill, should meet the strict regulatory requirements of a Section 351 product. Therefore, Axiofill will be subject to the marketing requirements of a Section 351 product under the FDA regulations related to Human cells, tissues, and cellular and tissue-based products (“HCT/P”). The agency communicated its decision in its determination letter in response to the company's Request for Designation. The issue relates to an FDA inspection in early 2022, after which the FDA said Axiofill is not a Section 361 product and instead will be subject to obligations under 351 products, which are associated with a costly and time-consuming path to approval. MiMedx ( MDXG ) has already filed a lawsuit related to the matter in a Georgia district court and said it “intends to exhaust all legal options available, given the arbitrary and capricious manner in which FDA is regulating like-kind prod
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MDXG
News
- MIMEDX to Host First Quarter 2024 Operating and Financial Results Conference Call on April 30GlobeNewswire
- Global Advanced Wound Dressing Market is on track to reach a valuation of US$ 8,374.50 Million by 2034 at a CAGR of 2.80% | Future Market Insights, Inc. [Yahoo! Finance]Yahoo! Finance
- Spectral AI, Inc. (NASDAQ:MDAI) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA [Yahoo! Finance]Yahoo! Finance
- MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDAGlobeNewswire
MDXG
Earnings
- 2/28/24 - Beat
MDXG
Sec Filings
- 4/24/24 - Form 4
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- MDXG's page on the SEC website