you seem genuinely interested in the timeframes for marketing authorization approval (MAA) for Mesoblast's products. Good for you. IMO an investment in a biotech like Mesoblast Ltd requires & deserves a high degree of openness to ideas from any conscientious investor.
Sadly, there are some who just can't, or for personal reasons don't want to, see what management have worked to put in front of us in terms of proliferating MAAs and ever shortening timeframes to approval.
Just on the point I posted on over the weekend i.e. about the EAP notice attached to NCT06325566, the confirmatory CLBP trial, here's a recent (8/2023) article from the Journal of Clinical and Translational Science which I think you & other interested Mesoblast holders will enjoy reading:
So, as I see it, the use of EAP-generated data (i.e. as acceptable RWE) in support of an accelerated approval is not novel - far from it, it's now becoming something which the FDA are familiar with.
Good to know.
Cheers GLTA(LT)H
MSB Price at posting:
33.0¢ Sentiment: Buy Disclosure: Held
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