Under his leadership, the biologics division could bring more scrutiny and requirements to developers creating new gene therapies. Earlier this year, Prasad said he wanted to see more stringent reviews,writing on X that “The FDA did nothing to speed gene therapy, other than talk about how they will use uncontrolled endpoints. But we want to speed effective gene therapy, not ineffective gene therapy. The FDA had no solution for that.”
FDA provided guidance to Mesoblast that the company was eligibleto file for accelerated approval of REVASCOR in patients with end-stage HFrEF based on the totalityof data across two randomized controlled trials.
Prasad wants rigorous proof but will speed up effective therapies.
He will be in this role for four years, more if Republican's reelected. How to effect major and lasting change in that time??
Dream HF was what,7 years of data? LVAD , 5 years of data?
I feel like a rather large pendulum is swinging our way.
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