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Stock Watch: The Two Sides Of A Complete Response Letter

Acadia Comes Out Guns Blazing While The FDA’s Hands Are Tied

 
• By Andy Smith

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

A complete response letter (CRL) from the FDA instead of an approval will always be a disappointment to a drug sponsor. But while companies can issue robust responses by press release, the FDA treats all interactions with the drug sponsor as confidential.

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