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Posted On: 11/29/2025 8:42:16 PM
Post# of 158771
Before the recent updates, I threw out there Cytodyn was most likely not including the ICI in our CRC, to stay aligned with the Briefing Book section on past CRC, due to no past PD-L1 / ICI observations.
You don't request it in current CRC before Briefing acceptance. ICI is not our battle to fight, per say.
Dr. J has since commented he's excited that the Briefing has presented potential improvements to current CRC trial.
That surely sounds like he secured ICI influence / backing baked into the mix, to the FDA on our CRC / ICI.
Now add the Data Safety Committe can too recommend ICI @ any point, & Dr. J / team / Advisory Committee, have played the CRC protocol 100% correct.
Protocol adjustment is the easiest of the bigger picture
Expecting news of bumped to 700mg's any day. No news @ this point , means it's been approved.
You don't request it in current CRC before Briefing acceptance. ICI is not our battle to fight, per say.
Dr. J has since commented he's excited that the Briefing has presented potential improvements to current CRC trial.
That surely sounds like he secured ICI influence / backing baked into the mix, to the FDA on our CRC / ICI.
Now add the Data Safety Committe can too recommend ICI @ any point, & Dr. J / team / Advisory Committee, have played the CRC protocol 100% correct.
Protocol adjustment is the easiest of the bigger picture
Expecting news of bumped to 700mg's any day. No news @ this point , means it's been approved.