Hi @chucke, yes, I agree about a partner for the 'blockbusters'...

Hi @chucke,

yes, I agree about a partner for the 'blockbusters' in the USA, but lets keep in mind that we do operate there & Mesoblast management has already put in place some strong strategic partnerships in the US, e.g. THI, Lonza Houston, the SurgCenter principals, which the Americans value highly (unlike Aussies in my experience). I undertand we're prepared to move particular product lines from Lonza Tuas to Lonza Houston, for example. So, it's not as though we're completely outside the market looking in.

IMO we will need that financing/ sales (but not necessarily research) partnership for HFrEF (w. LVAD) in due course - even more so than for CLBP, which I understand MSB has planned to cover for at least 12 mths funding atm (including the CRO commitments). I've been following CEO Itescu's comments closely re the need to have as a partner someone with an existing salesforce i.e. to keep our costs down & growth manageable. I really didn't think I'd be talking about CHF this way a little while back: I thought it would necessarily take a lot longer to get FDA over the line. But I've done my own research on the AA pathway & I think it's possible to work out a lodging of a BLA in CHF in H1 2024, depending on when the Type C is convened (& many other factors). Not advice to anyone, of course.

Ironically, if the FDA now agrees that just puts the ball back in our court i.e. to prepare & submit the BLA (for AA) and simultaneously nail down the (conditional) funding of the confirmatory trial that FDA absolutely will require if it were to grant approval.

I guess the size of that funding is an imponderable e.g. over what period of time could a required Ph IV ethically & otherwise acceptably defer recruitment? Could RWE fill the breach in the interim? I dont know the answers to these questions, but it doesn't change the fundamental need for a partnership in CHF generally to be in place at that point in time. What form it might take, & what role contributions the venturers would make is of great interest to me.

As I see it, the go/no go time will be within a month or so after the Minutes of the upcoming Type C (the pre-BLA) are released - because at that point all undertakings to the FDA will need to be underwritten or funded so that work on assembling the BLA can commence (and there's no room in the budget for anything like a 3rd trial (PhIII/IV) and won't be IMO until breakeven).

A good problem to have IMO. Fingers crossed.

Cheers
GLTA(LT)H