It certainly is the quarter to get excited...
OTAT feedback will enable
- The company to re-apply for GvHD approval
- The company to initiate the all cause ARDS / or 2nd Covid phase 3 trial
- Accelerate the closing of the Novartis deal and milestone payments if the feedback enables 1 or 2
FDA feedback on the final CLBP trial
1. Should enable approval for the final joint EU/FDA trial , and associated Grunenthal milestone payments
FDA feedback on the block buster Dream HF trial
1. Enables the company to continue with it's plan of a second phase 3, or possibly other avenues as directed from the FDA
AHA and NEJM article release
1. I suspect this is really going to turn some heads as the world comes to grips with the only treatment that has proven so far to halt class 2 CHF progression in it's tracks. Big money are going to come wanting a slice of the pie and may end with an agreement earlier than people think or realize. IMO this agreement is going to be much bigger than the Novartis deal.
2. I think this may well be the kick starter for Tasly's CHF studies in China since the results are so completely astounding. Remember the Tasly deal...
Mesoblast will receive double-digit escalating royaltieson net product sales in China. Mesoblast is eligible to receive six escalating milestone payments upon the product candidates reaching certain sales thresholds in China.
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