Excellent explanation, parent is also correct. I think the author’s position is misinformed. The FDA doesn’t hold back researchers on inclusion/exclusion crite

Excellent explanation, parent is also correct. I think the author’s position is misinformed. The FDA doesn’t hold back researchers on inclusion/exclusion criteria. Inclusion for the Moderna trial he linked to: > Must have primary refractory or acquired secondary resistance to prior immune checkpoint treatments. Primary refractory is defined as prior exposure to anti-programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) antibody for at least 6 weeks but no more than 6 months with demonstration of progression on 2 separate scans at least 4 weeks apart but no more than 12 weeks apart and progression occurring within 6 months after first dose of anti-PD-1 antibody. Acquired secondary resistance must have confirmed objective response or prolonged stable disease (SD) (>6 months), followed by disease progression in the setting of ongoing treatment and confirmed progression on scans at least 4 weeks apart. Exclusion criteria: > Participant has received treatment with prohibited medications (that is, concurrent anticancer therapy including other chemotherapy, radiation [local radiation for palliative care is permitted with approval from the Sponsor]… From the description of the patient’s treatment course it sounds like he had curative intent radiation (given he subsequently had surgery) and would probably not meet this study’s criteria making the limiting factor Moderna not the FDA. He also doesn’t mention whether he’s starting immunotherapy/checkpoint inhibitors (or his tumor status) and may be lumping immunotherapy with chemotherapy which is a good new treatment option and would typically be offered if eligible. Definitely better than being enrolled in a dose study and in fact is required by Moderna.