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MiMedx Group, Inc. Message Board

  • stemcellmagnet stemcellmagnet Sep 20, 2013 4:45 AM Flag


    FDA is about safety and Efficacy. This train has left the station and with 180,000 units sold with no adverse events we should have a great meeting with the FDA. In addition Mimedx agrees with the FDA that this space should be more regulated. When this is over Mimedx will have built another barrier to entry for competitors!

    Sentiment: Strong Buy

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    • The injectables will not be the short term driver of the stock as I eluded to in a new thread. The injectables remain a speculative play until the payers reimburse and that will require studies, regardless of how the FDA rules. For those of you who believe that this segment will fuel the growth MDXG in the short term will be disappointed. This segment a 5-10 year plus project before it bears the good fruit.

    • Yeah, the company will have a "great" meeting with the FDA and then everyone will go out to McDonalds for a Happy Meal to celebrate!

      Do you really think the FDA sent out this letter so they can later apologize and say they are sorry for destroying shareholder value, and causing all these lawsuits?

    • monarch6500 Sep 20, 2013 12:42 PM Flag

      The next letter from the FDA only has two outcomes and will be the catalyst.

      1. Micronization does meet drug status.
      2. Micronization does not meet drug status.

      If choice 1 then no change in sales because product still available while status resolved with studies.

      If choice 2 then no change in sales.

      All of these suits are without merit. If they want to sue someone the let them sue the SEC for removing the uptick rule. That is what caused the crash to below 2. Base the uptick on the prior day's close.

      Sentiment: Strong Buy

      • 1 Reply to monarch6500
      • My concern is FDA knows the available data, and has sent the untitled letter because they intend to pursue your option #1--and they will seek clarity then take it off the market after the meeting. Why else would they have taken their initial action? Regardless of the small part of the earnings, it will create uncertainty in the stock if the lawsuits are given a footing by the FDA. WHY would they have sent the letter in the first place?

    • Someone arranged a buy of 120,000 shares at the open today. I'm willing to bet it was one of the law firms or someone related to them.

      • 1 Reply to david_gaithersburg
      • lets call it a 120K "transfer" as the PPS slumped for the next 1/2 hour (true, on squat Vol but that was true all day) . Obviously someone took the other side of the bet but the market was not intrigued. If I had been watching, would have been hard to not reel in some fish at that level or close. Still charmed by the macd though its slightly mellowing and of course this is bio, hinging on a catalyst, & candles not co operating yet. Go get em Pete but FDA proves to me every day the dont care nought but for FDA.

        Tell you one more funny thing ; 80K bid 5 hours after close, (380K on the day) and on the NAS no less, not even the edgx crooks. Weird.

    • I appreciate your optimism but unless you can identify some catalyst, I think you're expressing wishful thinking. I do believe we'll have a $1 billion market cap company in the best two or three years. The recent FDA issue has created a buying opporunity.

    • What makes you think we should have a great meeting with the FDA?

      • 1 Reply to wemowgrass
      • Is there ever such thing as a great meeting with the FDA? But if you recall what Pete Petit said was he is in agreement with the FDA that this space should be highly regulated! So Pete Petit is willing to do what ever they would like. But also keep in mind that the FDA visited the Georgia Facility and gave Mimedx the approval to sell the injectable! (14 months ago) You can read the letter it is on their web site. So my guess is worse case scenario we have to do a "BLA". But while we do the ""BLA" we can still sell the product. So everything is still a go! This company will grow 90-100% this year with 84% margins. Terribly exciting!

        Sentiment: Strong Buy

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