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  • francolaval francolaval Aug 31, 2005 5:28 PM Flag

    Restricted approval plus....

    MRA of the abdominal vessles - or MRA of the renal arteries. The pivotal studies in this indication are quite unequivocal. Then, they may ask to do a comparative trial MS-325 in an MRA indication (or multiple MRA indication) versus current 0.5M standard. BUT, what's strange in all of this is that the FDA had given them approval of their plans many years ago, stating their current trial design was okay - but, they've seem to have changed their minds. I think there will be some pressures on the FDA to get their act together and approve this agent.

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    • <<BUT, what's strange in all of this is that the FDA had given them approval of their plans many years ago, stating their current trial design was okay - but, they've seem to have changed their minds. I think there will be some pressures on the FDA to get their act together and approve this agent.>>

      Hope so. Seems like it's one of those situations where they might. But I agree that EU approval would be a good thing all by itself.

 
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