Media Thread, page-18234

Thanks for that input .
In trying to follow (my own ) logic , and looking at the FDA announcement extract as below ....given that 81 patients were in the IMU trials as per the July 2024 Preso , if these numbers have or were increased and results continued to show growing promise ....would this open the case for IMU to be escalated to Phase 2/3 .....or must be an entirely new "Trial basis ". set up under FDA independent criteria ?
Again ..apologies for perhaps the naivety of the question , just trying to evaluate the context of the last sentence from the FDA ANNOUNCEMENT , which I have repeated :Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.”
Thanks for any comments that might follow .


“The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies. REMS is a useful safety system, but reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,” said FDA Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research. “Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.”