House, yes, I think you would be correct about the timing of an amendment before the start of a trial. As in the Cytodyn May 13 Press Release, I think the only amendment was to prospectively collect PD-L1 data on the CRC trial patients.

If a patient doesn't satisfy the trial requirements, such as choosing other treatment options, moving away or being lost to follow up for other reasons, I don't think his/her data can be included in the analysis (the data might help the company decide on future strategies, but not as part of the trial).

Would the DMSB stop the trial early based on smashing success? I don't know. I hope the trial will enroll and finish quickly, that Cytodyn can show the validation of LL's MOA, and that the checkpoint inhibitor companies can start bidding.