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OCATA THERAPEUTICS, INC. Message Board

  • FIGHTERPILOT FIGHTERPILOT Jan 10, 2010 9:55 AM Flag

    How many animal tests?

    Does anybody know how many animal studies the company has conducted with published results? If good results were achieved in a particular study on which the IND is mainly based, the FDA quite often wants to see those results repeated in a second confirmatory animal study with the same parameters.

    Sorry I have not followed this company that long to know the answer, but I do know that this is today a common request by the FDA.

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    • Fighter, I've never seen any numbers to that question. I only know they have run test for at least three years, and with several different animal models.
      They have also been working with the FDA for several years on this issue, pre-IND meetings with the FDA, they were one of three (ACTC, GERN, and ISCO, if I'm not mistaken) companies ask to meet with the FDA concerning hESC's.
      Lanza also said one time,"we pretty much know what they (FDA) is looking for."
      So, I can only hope that any issues are minor and this point, and the FDA simply put a hold on the process to slow things down a bit since this is a new process and treatment for everyone. Plus, I feel the Orphan status complicated things a bit for the FDA and they need to get a full understanding of their role and how things are going to proceed from both sides.
      GLTA

 
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