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InVivo Therapeutics Holdings Corp. Message Board

  • twrose12000 twrose12000 Jan 27, 2013 12:30 AM Flag

    feels closer then ever.......?

    feels closer then ever.......?

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    • It feels close, but it is just one piece in the puzzle. HUD is a nod, and they still need the IDE approval to start trials. After the trials start and they are looking good (expected) then the final approval that opens up marketing (and revenues) in restricted quantiy is the HDE approval. Someone correct me if wrong, but this is what I am reading here and elsewhere.

      So... say HUD comes this week, IDE comes soon afterward, then human clinicals can start at any time thereafter but lets say positive clinical data is in before the end of Q2... I would suppose then the HDE application is submitted in Q3 and then another wait from FDA, but you'd have to expect the HDE by Q4 or better and so that means NVIV could be pulling in revenues from the scaffold in Q4. The hydrogels have their own time table. Lots of positive catalysts in 2013.

      Sentiment: Strong Buy

1.99-0.20(-9.13%)Jan 29 3:59 PMEST

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