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InVivo Therapeutics Holdings Corp. Message Board

  • jmnotechie jmnotechie Dec 16, 2012 11:32 AM Flag

    clean batches submitted?

    Question for those more knowledgeable about the FDA process than me. The following is from the
    business update of Nov 12:

    •Biopolymer Scaffolding for SCI: FDA approval to commence an open label clinical trial of five acute SCI patients is expected in early 2013. The Company expects the product to be regulated under a Humanitarian Device Exemption pathway that should accelerate commercialization. Before the end of 2012, the Company expects to validate its manufacturing clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application.

    On Friday, NVIV requested HUD approval from the FDA. Is this the same as the IDE application referenced above and does this mean NVIV now has validated it's clean room and submitted GMP batches to the FDA?

    Sentiment: Strong Buy

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    • "Before the end of 2012, the Company expects to validate its manufacturing clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application.

      On Friday, NVIV requested HUD approval from the FDA. Is this the same as the IDE application referenced above and does this mean NVIV now has validated it's clean room and submitted GMP batches to the FDA?"

      That sounds like a reasonable interpretation to me.

      Sentiment: Buy

 
NVIV
0.97+0.02(+2.11%)Jul 28 3:51 PMEDT

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