On the ARDS trial, in my stats I was working off a 10% target improvement, which is reasonably easy to meet. While this does leave some room for post-hoc analysis on secondary endpoints to show some real promise, I think they should have published a few more details about the trial and what threshold they were trying to achieve. I was also under the impression that the Bayesian endpoints were only in use for the interim analyses - so much of the trial design was not public, so the shock of what they were actually going for was a big one for me. However...
If covid reinfection is possible (seems likely) and there is some promise in the full trial data, then the next phase 3 trial could be for "all cause ARDS" (ie. including covid) targeting patients a little earlier in the process and with guidance on trial design from novartis. There's a chance the cells don't work reliably enough and in a consistent way that they will be able to pass a clinical trial... but honestly the ARDS trial was so hastily put together and not safeguarded against the changing nature of the virus, that there's a 50% chance it's bad/unfortunate trial design and a 50% chance it's the product. If I am novartis, I might just buy mesoblast in entirety for a broad offer of something like $3.50 a share and take the tech forwards myself, rather than dicking around with any milestone payments. If not, then I expect them to be heavily involved in constructing the trial design and using an endpoint that can be met for approval from the FDA or in Europe.
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