The FDA Reversed Course on a Huntington's Gene Therapy — and a First-Ever Filing Is Coming
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YouTubeNorthlance
The FDA Reversed Course on a Huntington's Gene Therapy — and a First-Ever Filing Is Coming
uniQure (QURE) says the FDA, in a recent Type B meeting, will accept the three-year analysis from its Phase I/II study as the primary basis for a Biologics License Application for accelerated approval of AMT-130 in Huntington's disease — instead of the sham-controlled trial the agency had pushed for. The company plans to file in the third ...
1 day ago
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