Amniofix IS FDA Approved

From MassDevice in March 2018:

MIMedx won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week.

The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee.

Can we stop with the talk that AmnioFix is not FDA approved?!?

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All the MiMedx reps were put at risk by this unethical management team and ended up breaking the law by stating AmnioFix was actually FDA approved. Now that MiMedx is in a free fall I would like some of the posters on this thread to come out and admit they were wrong. Acceptance is the first step.

good luck with that.

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All the MiMedx reps were put at risk by this unethical management team and ended up breaking the law by stating AmnioFix was actually FDA approved. Now that MiMedx is in a free fall I would like some of the posters on this thread to come out and admit they were wrong. Acceptance is the first step.

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The problem with this post is that the writer does not understand Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. This designation is NOT "approval" of a particular therapy. It is instead a STATUS given to a particular therapy whose developer claims that it has regenerative potential, and there is some evidence to back up the claim. If RMAT status is granted, a developer may proceed with therapeutic trials to test whether, in fact, the particular therapy meets the FDA's standards for approval.

Pete likes to argue similar points kind of like you...coincidence?

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The problem with this post is that the writer does not understand Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. This designation is NOT "approval" of a particular therapy. It is instead a STATUS given to a particular therapy whose developer claims that it has regenerative potential, and there is some evidence to back up the claim. If RMAT status is granted, a developer may proceed with therapeutic trials to test whether, in fact, the particular therapy meets the FDA's standards for approval.

They may not understand the ins and outs of what you do but now everyone, including payers, are waking up to what many people have known for a while. You speak of the FDA? They're waking up too.

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The problem with this post is that the writer does not understand Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. This designation is NOT "approval" of a particular therapy. It is instead a STATUS given to a particular therapy whose developer claims that it has regenerative potential, and there is some evidence to back up the claim. If RMAT status is granted, a developer may proceed with therapeutic trials to test whether, in fact, the particular therapy meets the FDA's standards for approval.

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Do a story on ALL the employees who will end up losing their job at MiMedx because of Parker's shady behavior and the complicit upper management. Good people just wanted a job and now they will be on the street once this house of cards falls.

is the short term, 3 options may happen to Mimedx

1. File Bankruptcy, Default on debts and get taken over by a private equity firm

2. Get bought out by a bigger company for a bargain price of 25% of what it was worth a year ago

3. Clean house of all bad apples , Bring in all new leadership, restate all the financials for last 6 years and try to come out current downward spiral . Could take years

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I am a journalist doing research on MiMedx and I would like to know what the sales reps have been told since Mr. Petit's resignation. More pressing is how have the sales practices changed at MiMedx since the DOJ and SEC investigations started. Thank you.

Do a story on ALL the employees who will end up losing their job at MiMedx because of Parker's shady behavior and the complicit upper management. Good people just wanted a job and now they will be on the street once this house of cards falls.

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I am a journalist doing research on MiMedx and I would like to know what the sales reps have been told since Mr. Petit's resignation. More pressing is how have the sales practices changed at MiMedx since the DOJ and SEC investigations started. Thank you.

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Fact: $MDXG is one of the most shorted bios out there right now.

This doesn't happen by mistake or because of one person.

Even more shorted now that the CEO resigned this morning.

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Fact: $MDXG is one of the most shorted bios out there right now.

This doesn't happen by mistake or because of one person.

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When will Surgeons and Hospitals realize this company is nothing but a Fraud?

Their business practices, marketing, selling,and finances are some of the shadiest I have ever seen by a medical device company. But somehow they have duped a lot of smart surgeons in believing that the same placental tissue can be called 10 different names with different forms , powder , sheets , injectable , etc and all have different uses without any long term reputable studies

Hospitals apparently have started to realize the fraud that MiMedx is --

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Replaced CFO

Restating earnings

--What insure(s) will remove MiMedx products from their formulary next?

When will Surgeons and Hospitals realize this company is nothing but a Fraud?

Their business practices, marketing, selling,and finances are some of the shadiest I have ever seen by a medical device company. But somehow they have duped a lot of smart surgeons in believing that the same placental tissue can be called 10 different names with different forms , powder , sheets , injectable , etc and all have different uses without any long term reputable studies

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When the going gets tough, Parker Petit and MiMedx don't want to answer the tough questions. They pulled out of the Jeffries conference today and sited a "last minute business conflict" as the reason why. Going to the conference would have exposed them to questions from analysts about the Sparrow lawsuit, channel stuffing, VA lawsuit and why multiple insurers have been dropping AmnioFix from there formulary. Why hasn't the rest of the investor world realized the fraud that MiMedx is selling to them?

Replaced CFO

Restating earnings

--What insure(s) will remove MiMedx products from their formulary next?

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there is a bigger underlying issue from the top down at Mimedx. The reps are being fed the lies from the CEO , Managers , and Marketing. The reps are not dumb, they keep perpetuating the smoke and mirrors to keep the sales up with the high pay day.

When the going gets tough, Parker Petit and MiMedx don't want to answer the tough questions. They pulled out of the Jeffries conference today and sited a "last minute business conflict" as the reason why. Going to the conference would have exposed them to questions from analysts about the Sparrow lawsuit, channel stuffing, VA lawsuit and why multiple insurers have been dropping AmnioFix from there formulary. Why hasn't the rest of the investor world realized the fraud that MiMedx is selling to them?

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