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Isofol Medical: Agent trial to be completed without extension - Redeye

Redeye believes the recommendation from independent reviewers (DSMB) to complete (but not extend) the AGENT trial indicates a good chance of meeting the primary endpoint of improved tumor response rate. However, since there is no study extension, proving significant benefit in progression-free survival (PFS) (the key secondary endpoint and important driver of commercial potential) could be challenging. We adjust our base case to SEK 32 (35) as we assume a higher likelihood of approval (for PFS, a positive trend will be enough) but somewhat lower peak sales.

Redeye believes the recommendation from independent reviewers (DSMB) to complete (but not extend) the AGENT trial indicates a good chance of meeting the primary endpoint of improved tumor response rate. However, since there is no study extension, proving significant benefit in progression-free survival (PFS) (the key secondary endpoint and important driver of commercial potential) could be challenging. We adjust our base case to SEK 32 (35) as we assume a higher likelihood of approval (for PFS, a positive trend will be enough) but somewhat lower peak sales.
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