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CryoLife Inc. Message Board

  • dlhild Apr 9, 2013 12:00 AM Flag

    Google "Cryolife FDA warns implant maker".

    You will find an April 7, 2013 article from The Atlanta Journal-Constitution. The article was written by Lois Norder. It amplifies on the previously discussed FDA warning letter.

    I'm wondering whether the FDA warning letter is actually more serious than SA made it appear during the last conference call. Also, I'm wondering whether the PerClot clinical trials are being delayed in part because of all this other FDA stuff. I know SA said in the last CC that the FDA enforcement and FDA clinical trial groups were separate tracks. Maybe, but you have to wonder about his answer. The recent HeRO Graft approval would argue in his favor on this though, but who knows for sure?

    Also, this again gets back to the question of whether CRY should entirely exit the cardiac and vascular tissue businesses. If SA isn't careful, the no/low profit cardiac and vascular cost centers are going to sting CRY with a big liability judgement similar to the Brian Lykins one in 2001. These two cost centers don't appear to be profitable, so why run the liability risk?

    There appear to be two cases where potential problems with the manufacture of BioGlue many have been present. BioGlue is generating most, or all, of CRY's current net operating income. If CRY would have their BioGlue sales impacted in a serious way, who knows how low the stock price might fall? Obviously, this would be a great time for the executives to sell more of their free option grant shares.

    Google the article. Read it. Draw your own conclusions. You are responsible for your own due diligence.

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