Jul. 29 at 10:53 PM
$CLNN think you're underestimating CLNN's management. This isn't a first-time biotech team learning the FDA process. They have decades of experience in drug development, regulatory affairs, clinical development, and commercialization.
I'm sure they're watching every high-profile FDA decision, including CAPR's AdCom, and incorporating those lessons into their own strategy. Any competent biotech preparing a BLA would do exactly that.
Yes, the FDA expects rigorous statistics, a prespecified SAP, and clear justification for every analysis. That's nothing new. Those are exactly the issues experienced management teams spend months preparing for and discussing with the FDA.
At the end of the day, approval will come down to the quality of the data—not the assumption that management is walking into the BLA unprepared.
