Ann: Phase 1B brain cancer clinical trial approved for initiation, page-9

This is just an ethics approval tho - nothing related to the FDA. Mostly a review of protocol, documents used in the trial, and documents given to patients, etc and see if patient's rights and welfare are protected throughout the trial. They do evaluate risk/benefit rationale for the trial, but quite different from the cost/risk/benefit analysis the FDA does.

Also, the confirmation trial at Phase 2 with really no complete responses in Phase 1 is quite a stretch.

Need to see complete responses or even partial responses. If there has been and I just missed the announcement, please let me know.