makes perfect sense. Yes, there were information arm and compassionate arm going that time that you can see how the treated patients are doing in terms of pseudoprogression in those single arms. Plus Keytrudas were trumpeting pseudoprogression issues.
FDA does not swing from the hip. Add patients to your study or change primary endpoint or both.
Decide an ECA is an acceptable, approvable design when a validated database does not exist…implausible.
Change your only pivotal trial design voluntarily for your lead asset with no existing product portfolio, please explain how this is not material? How about after data lock?