Pick Today's Price Range Low-High... Just for Fun, page-147

@whytee says:

"The FDA don't make unsolicited responses"

They did exactly that with CHF when they invited MSB to submit additional data from the DREAM-HF trial to see who benefited the most from Rex.

"In recent guidance to Mesoblast, FDA confirmed that reduction in incidence of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is a clinically meaningful acceptable endpoint in patients with chronic HFrEF and encouraged Mesoblast to identify the highest-risk group with greatest likelihood of beneficial response to intervention with rexlemestrocel-L in the DREAM-HF Phase 3 trial."

And now, after a painfully long wait, we have guidance to apply for AA.