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Momenta Pharmaceuticals Inc. Message Board

  • daniellaki daniellaki Feb 15, 2005 3:52 PM Flag

    Question. Please help me understsand

    Obviously the benefit of generics is that yu don't have to go back and reinvent the wheel
    with clinical trials.

    Buty it would seem that with Biotech Generics, there is no guarantee how FDA would view this perhaps in particular based on recent development with MRK's product.

    Does anyone here more of a grip on this. Would the FDA tell the company their thinking before they went through the whole ANDA submission

    Are there any models with other companies that give us an idea in advance?

    Could all there be variations based on the nature (problems seen etc.) of the BASE product the company is building on?

    Or is this PLATFORM ACCEPTED by FDA to be automatically more safe?

    Does the ANDA the company intends to submit basically ask for the ability to market? Or test efficacy in humans?

    Any help in these areas would be greatly appreciated.


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