Heimlicht
Oct 12, 4:36 PM
$CA Nov 22 is a coin flip with a loaded coin, and the moon boys are pricing it like a lock. The adcom voted 9-3 AGAINST on July 29. That's not a "mixed panel," that's the FDA's own experts saying no. Add the 2025 CRL for weak efficacy and CMC problems, plus a last-minute pivot to "upper limb only" after the main story got picked apart. The 3-month extension isn't a victory lap, it's the FDA reading a rewrite.
Could they still get approved on rare disease flexibility? Sure, ~15% in my book. But CRL is ~75% so the hopium crew yelling "PRV incoming 🚀" is out here buying lottery tickets and calling it DD.
Wake Up People, Dont destroy you or families finances b4 Christmas
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