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Posted On: 10/15/2025 5:54:47 PM
Post# of 158066
Quote:
The Data Safety Management Board can recommend that all patients who show progression be moved over to a leronlimab + PD-L1 inhibitor treatment.
How fast is a process like this? Does it take days, weeks, months to get them moved over to something that may save their life?
The DSMB will outline the recommendations with the rationale for the changes and send them to Cytodyn. Cytodyn will kick this up to the FDA. With progression and a greatly increased chance of death the FDA will be more likely to move faster and be more willing to allow the changes especially with the rationale supported by the mTNBC data. Once the changes are allowed they will apply to all patients going forward.
The same would apply to a switch for all patients from 350mg to 700mg.
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