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Insmed Incorporated Message Board

  • fudfighter3 fudfighter3 Mar 21, 2014 1:28 PM Flag

    Look for reasons for the FDA to REFUSE approval

    The objective of the new legislation is to "encourage" the FDA to expedite the availability of drugs where there is data "reasonably likely to predict clinical benefit" in "unmet medical needs for serious or life-threatening diseases or conditions".

    The most effective drugs currently available to the NTM patient population require the patient to endure serious side-effects for a minimum recommended period of two years.

    The most effective drugs currently available to the CF patient population are only able to halt deterioration in lung function for a month or two.

    The FDA will have data showing that Arikace halted the deterioration in lung function in CF patients for a year (and counting).

    What reason could the FDA have to refuse to use its new powers to make Arikace available to the US CF patient population?

    Hopefully the data from the NTM study will be considered by the FDA "reasonably likely" to predict a clinical benefit in a second unmet medical need.

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