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Ann: PAA completes Phase 1 and files for Orphan Drug Designation, page-394

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    Hi Quiltman,

    I agree that if MPL is granted approval for MND then the pathway to market for other neurodegenerative diseases could be relatively rapid. I wonder if a formal Phase 2/3 clinical trial for selected other indications would even be necessary.

    I'm uncertain about this but perhaps an open label study might be enough to attain approval for prescription of MPL for FTD. Does anyone know of a precedent for this situation?

    It's cart before horse on this speculation. The primary goal is to confirm our Phase 2/3 effectiveness on MND,

    Cheers, Thrifty

 
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