Dr. Magill also recommended that a postmarket study address pediatric patient populations.
"There are several unanswered questions about other patient populations, like pediatrics, and potential for other indications. I think what happens next is very important, whether it’s a postmarketing surveillance of some kind, required phase IV studies, or the sponsor seeking new indications with new data and a new trial," Dr. Magill said. "I’d be looking forward to see how that evolves."