For information about the ECA/crossover design, endpoints, and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.
Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.
Correct, we have approval from all 4 RAs for the SAP, but this isn't a public process. What is crystal clear and in the public domain is the MHRA approving the same trial design for a pediatric trial. It's clear we have buyin from the regulators. Thanks for pointing this out.