jorgegb
Sep 25, 8:21 AM
$CHUC WSJ: FDA expected to announce in coming days it will revisit the 2021 PMTA rule, simplifying scientific study requirements and speeding review times.
Why this matters: the 2021 rule is the framework used to deny CHUC's PMTAs. The comparative-efficacy requirement the Fifth Circuit ruled was unlawfully applied in NicQuid? That came from this rule. Revisiting it doesn't just lower the bar going forward, it potentially unlocks 678 timely-filed PMTAs already in the queue.
Henry's words: 'The unwieldy PMTA review process has punished hundreds of small American businesses. Meanwhile billions in illicit Chinese product flooded American streets.'
6 years. 678 PMTAs. Products in the warehouse waiting to ship.
Honest risk: plans could still change. Litigation certain. Cash clock still running. But if this happens as reported, the regulatory wall blocking CHUC for 6 years doesn't just crack. It comes down. Heidi Overton's FDA confirmation hearing, slightly positive for CHUC.
$BTI $MO $PM
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