How is this figure of 206 obtained? You can minus 1 because I am total out now. It was disheartening to see a huge profit got wiped off and I haven't still got over it. You did your research weighed the all risks that you could possibly could and thought aGVHD was 95% in the bag. The 5% risk was there for something something unknown, something no one would have thought and then you got hit with something so fundamental and basic, the trial design, like 45% null hypothesis and DOR (against FDA's advice). And also at the start Mesoblast was planning for accelerated/conditional approval then somehow along the line they decided to submit the BLA for full approval. And all the while Mesoblast gave you the impression that they worked closely with FDA!!!
I just think Mesoblast has not been completely transparent to its shareholders.
I'd also like to see the exact wording of the CRL. I think the problem is not just the trial being single arm, i have the feeling that the FDA is not entirely happy with the design and control of this single arm. So there is a very good chance for the accelerated approval that Mesoblast is requesting is not going to be approved.
the approval of Ryoncil for me was the foundation for Mesoblast to enter the market, the anchor for the progress of other products in the pipeline and more importantly the acknowledgement of the science. All that has fallen apart and that leaves everything else hanging in the air and prompts questions to what we have been told.
Good luck to all holders, I may enter again if the price is right for the risk/reward ratio.
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