" I can’t imagine the company not having become smarter with the way it runs these trials, or working out the shortest possible way to approval "
these are all good points. I believe I've made similar points about Tenet long ago on HC:MSB. And I see your focus is on the CLBP trial, no doubt because clinicaltrials.gov has listed it (& put its existence beyond downramper speculation).
However, when I think about the practical hard-nosed differences between Rex for CLBP and Rex for CHF, as general projects, I get to a point where the differences right now - i.e. for management planning purposes - boil down to 2 things:
1) first, unexpected (by me) expression of FDA support for MSB pursuing the AA pathway specifically in HFrEF with LVAD; and
2) second, the fact that the confirmatory CBLP trial (for standard approval) is demonstrably up & running i.e. after FDA agreement on the clinical trial protocol.
Apart from that, both projects have as project assets equivalent RMAT designations, Ph III clinical data available, the benefit of a 'zero issued 483s' facility PLI (albeit for a different indication & indication processes) of the currently intended Singapore manufacturing facility, favourable prior signoff of some kind by FDA on potency issues etc etc. Of course, the risks and benefits associated with each project's outcomes data, characterisation data etc is an imponderable known only to the FDA.
So, which wins out IMO? Well, in the absence of a similar expression of FDA support for MSB pursuing the AA pathway in CLBP, it has to be HFrEF, as I see it. In other words, unless and until the FDA does something new to show Mesoblast that it recognsies the potential for a shorter pathway for Rexlemestrocel (in CLBP), the money has to specifically follow the HFrEF with LVAD indication for Rex.
That's as I see it, atm. Could be wrong. Often am. New options are starting to gel as we speak. Exciting times.
PS: I see the multi-center aspect of the newly published CLBP trial as likely tying in with Tenet (via SurgCenter principals & Philip Facchina). Time will tell.
PPS: Note that the zip code for Mesoblast enquiries on the CLBP clinical trial is in Austin, Texas. Interesting, eh.
(20min delay)