These excerpts look hopeful …. “I know that in some of the...

These excerpts look hopeful ….
“I know that in some of the decisions that I've made, it's possible that I'll be wrong,” Marks said. “But I can live with that in the bigger picture of knowing that it's important for us—for the community to know—that we're not so dead set on getting it right 100% of the time that we actually prevent things from getting to market that could potentially help people a bit sooner.”

Safety data is a red line for Marks, however. He asserted that he would never overrule reviewers if there were questions about safety.

Marks’ Sarepta ruling has, so far, caused much less consternation than the agency’s decision, backed by the Biden administration, to recommend a first round of booster doses to all eligible Americans in the fall of 2021. The decision, relayed in a joint statement from top health officials in August 2021, caused internal dissent and spurred the departure of two top deputies, Marion Gruber, Ph.D., and Phil Krause, M.D. The two scientists penned an editorial in the Lancet a couple of weeks after their planned departures were announced arguing that evidence at the time didn’t support boosters in the general population.