Acadia preps for battle as the FDA rejects a potential blockbuster application
The rolling argument about whether or not the FDA is getting tougher this year just got a fresh spur in favor of the affirmative.
Just a few weeks after the FDA signaled trouble for Acadia’s blockbuster pitch to expand the dementia franchise for Nuplazid, the biotech is back this morning with news that the FDA has handed over a CRL. And execs seem ready to throw down over the rejection with regulators as soon as possible, as a slapdown here would likely require at least one major trial to cure the FDA’s objections.
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