I read this article again over the weekend (below) and IMO it could infer that the FDA have had the CHF meeting with Mesoblast and provided feedback on same ? ...... but then again if you look at the DREAM-HF ASX announcement on Feb 28 Mesoblast also claim they can use the data from both the DREAM-HF phase 3 trial and the LVAD phase 2b trial so that is perhaps the two trials referenced by the FDA ?
It's about as clear as mud so some clarity on the matter from the company would be good; especially seeing as Perin is then quoted as saying this after making the two trial comment:
"This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024."
blob:https://www.marketindex.com.au/74fe0724-534b-42b6-a7a6-4bebffb0abec
https://houston.innovationmap.com/t...&utm_medium=social&utm_source=twitter
“They said, ‘We can’t approve it with one trial, but we’ll approve it with two,’” says Perin.
This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024.
Once the FDA approves a new catheter system for injecting the heart with stem cells and genes, the team will proceed with new studies. Gene therapy will be another frontier for Perin — and patients with heart failure.
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