Episode 59
Biotech Hangout
00:00
The FDA Issues CRL for Combination Use of Lead Candidate and Patients With Non-Muscle Invasive Bladder Cancer
The company was down 55% Thursday and then down more today after management announced the FDA issued a CRL for its BLA seeking approval. The product is an IL-15 super agonist to be used in combination with BCG for non-muscle invasive bladder cancer that has failed BCG already. And when you read something like that, this close to the PDUFIDATE, you kind of have a feeling that it's not going to be good news.
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