Hi irenekwshiu,
" I wonder if Dream-HF trial could be considered as the confirmatory trial for the HF LVAD trial? "
I think not. There's no doubt that Mesoblast intends to hang its accelerated approval BLA in large part on the DREAM-HF results, in tandem with the earlier LVAD outcomes. However, I don't think CEO Itescu expects that the two trials together would, or could be made to, satisfy a post-marketing approval condition attached to any accelerated approval which may be proffered by the FDA later this year.
Without detailing why (and I do agree with your point on MOA & would take it even further), I think it's enough to refer to CEO Itescu's comments during the November 2023 AGM when he said, in passing, in relation to the CHF plan of action for 2024:
" ...So we know exactly where these cells work. We understand the underlying mechanism, and the objective is to replicate these data just like we are aiming to replicate the back pain data... "
and re the funding & timing of that CHF replication:
" So again, you can never predict when exactly these partnerships can be signed up. But suffice to say that we're in quite advanced discussions in both the back pain and the cardiovascular space with potential partners who are well aligned in the space with us and appreciate the data and the opportunities. And I think the further interactions with the FDA progress, the more attractive those discussions. But again, I can't give you -- I can't tell you whether it's next week, 6 months, but they're very advanced. They're in advanced discussions that are active and ongoing. "
Well that was still a Ph III trial he was talking about, and that was then. Before the Feb 24 meeting & the FDA showing its hand on support right now for the accelerated approval pathway for Revascor for CHF with LVAD. Now that planned further Ph III trial morphs to a Ph IV confirmatory, as I see it. But it will still need to focus on providing FDA with significant evidence of an efficacious primary endpoint (which DREAM-HF was unable to provide).
I'll post more on this 'perfect storm' of opportunity, but Mesoblast is now in March 2024 being deluged by opportunitites for early approval, as I see it. This will load up Mesoblast's deal-making capacities and test them to the hilt, as I see it. Especially up until the 19th.
It's a great problem for holders to have IMO. Hope this assists.
Cheers,
GLTAH
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