The settlement between OSIR and FDA might provide us a big clue to how things may conclude between the FDA and MDXG.
We now know that the FDA will regulate Grafix has a drug and the product will require a BLA. In addition, Grafix will remain on the market. The letter to OSIR was dated on Sept 26 and OSIR settled in less than 30 days. An interesting question is whether or not OSIR fought the decision or agreed with FDA for a prompt resolution.
FDA wishes to regulate the injectables as a drug as well and is requesting a BLA...anybody see any pattern here? It would appear that the injectables should remain on the market regardless if it's classified as a drug or not. I would think this decreases the "uncertainty" factor.
Regardless, MDXG will need to fund trials for the injectables for the payers. Too many people forget or do not realize Amniofix is essentially cash pay. Product will not grow considerably without reimbursement.
Again, I see it increasingly unlikely that MDXG will be asked to withdraw the injectables (OSIR, FDA).
1) If MDXG has to obtain a BLA(s), it should strengthen its position with the private payers via solid clinical data with the FDA stamp. Injectables revenue will not grow without wide reimbursement. We need data.
2) If any injectables remain 361, we continue the status quo. But we still need data for wide reimbursement especially clinic based procedures.
I'm very bullish for Epifix. CMS proposed rule (a big deal for all shareholders) or not. We are set to soar regardless, IMO.
Simply not true! Mimedx has never gotten a 483. Which I guarantee Osiris was issued one back in June after they got an early inspection. They have been messing with the FDA for months! Their inspection shouldn't have been until July 2014. They got an early inspection which says something was up!