Trodelvy is SOC because it's been approved. Any number of drugs in the clinical trial stage can come along and get BTD if they are a substantial improvement over SOC. But the FDA even admits that there is no clear cut definition for substantial. Given that Leronlimab had a small improvement shown in mOS but would obviously improve further and a good improvement in PFS coupled with far superior safety should have been enough. What I can't understand is why Cytodyn did not continue to track deaths and turn that over to the FDA as they received results.

Quote:

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To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

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