@col69
Do you honestly think Mesoblast would have been so public about this submission, without receiving reassuring words regarding their regulatory pathway from the FDA ? If the data shows consistency in mechanism of action (which Mesoblast has just validated ) through all four trials, questions over “hypothesis generating” results look pretty academic to me ! This forthcoming FDA meeting could change perceptions of this stock materially …in my humble opinion. I am surprised that Mesoblast has been sitting on such “bombshell data” for so long. I recall that Prof Bolli has already noted improvements in LVEF in the meta data of some other autologous MSC heart trials …but was unable to arrive at similar conclusions with regard to the Dream trial because the data was not available at the time of publication ..so the missing pieces are now falling into place. A trial involving LVEF as a surrogate endpoint under an accelerated approval pathway would be extremely well received ...Fingers crossed …i believe we have every reason to be optimistic because the data from rigorous RCTs appears to confirm the hypothesis. OP
Please do not rely on the opinions expressed in the above post when making an investment decision.
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