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uniQure NV Stock Forum
Benzinga· 3 mins ago
-As part of uniQure's Regenerative Medicine Advanced Therapy (RMAT) Type B meeting held in late November, the FDA agreed that data from the ongoing Phase I/II studies, compared to a natural history external control, may serve as the primary basis for a BLA submission under the Accelerated Approval pathway, avoiding the need for an additional pre-submiss...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
uniQure has reached an agreement with the FDA on key elements for an Accelerated Approval pathway for AMT-130, their Huntington's disease treatment. The FDA agreed that data from ongoing Phase I/II studies compared to natural history external control can serve as the primary basis for a Biologics License Application (BLA), eliminating the need for ad...
4 MINUTES AGO, 7:05 AM EST
VIA GLOBENEWSWIRE
I went with the wrong Curi! lol, both are good LT though
$uniQure NV (QURE.US)$
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