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InVivo Therapeutics Holdings Corp. Message Board

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  • rx7171 rx7171 Dec 16, 2012 11:11 PM Flag

    clean batches submitted?

    "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

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