(Total Views: 274)
Posted On: 10/15/2025 10:33:40 PM
Post# of 157986
Do we know if these specific TNBC and CRC subtypes are always PD-1 negative or do they have to be PD-1 negative to be enrolled in the trial. If a patient' cancer is naturally PD-1+, they are probably doing well on a checkpoint inhibitor and would not be enrolled. If they are negative, does the trial protocol specifically forbid testing them for PD-1 approximately every month? If not, and they are tested monthly, and are now PD-1+, would it now be considered unethical not to go ahead and treat them with a PD-1 inhibitor. I guess what I am asking is if regular PD-1 testing is not forbidden in the trial and CYDY pays to have it done, would the FDA's hand then be forced. Would it look bad in the public eye for the FDA to tell a clinical site that they are forbidden to use a PD-1 inhibitor in a PD-1+ patient. Would the FDA get upset and punish CYDY or the clinical site for doing PD-1 testing to avoid putting them in a tough spot.

