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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: erippetoe who wrote (63278)	11/4/2025 10:58:24 AM
From: li3511	3 Recommendations Recommended By erippetoe jhcimmu Oiji Read Replies (2) \| Respond to of 63311

> which could impact the transition from accelerated to traditional approval Not only that, it could cause the accelerated approval to be withdrawn. Accelerated approval is conditioned on the success of a confirmatory trial. Expect an emotional fight, and much more volatility in SRPT than we've seen thus far today. I don't think the market has fully realized the level of increased risk. Sarepta could agree with FDA to run yet more trials with different endpoints, keeping accelerated approval in the meantime. However, there's no guarantee that payers would continue to cover the therapies, because they've been proven to not work for their currently approved purposes.