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No. of Recommendations: 3
Baffled by this one. Hoped to get more insight into what went wrong with TCDA. Instead I found stuff like this:

a) veverimer has a novel surrogate endpoint
b) there is little precedent for accelerated approval of cardio-renal drugs

Huh? FDA accepted the surrogate endpoint and now is... well...., not so accelerated

FDA determines that precedent is a factor in granting accelerated approval? This is an easy one. If precedent matters, don't grant accelerated approval in the first place.

Major disconnect between the bodies within FDA who grant breakthrough and accelerated status and the actual voting panels and TCDA is the middle, IMO.

TCDA data is among the most convincing I have seen in over 35 years of biotech investing. This isn't a TCDA problem, it's an FDA problem. I will hold for sure. Probably dead money for a year to two. Might buy more, but will wait another 24-48 hours until I can screw my head back on.

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