MSB 1.01% $1.00 mesoblast limited

Thanks Superior. I don't see the lack of an update on the...

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    Thanks Superior. I don't see the lack of an update on the Dream trial as a negative or positive, just that a conclusion on the agreed pathway has not yet been established. Perhaps discussions on the LVAD population and quickest pathway to approval has taken priority. I do agree that it is frustrating.

    Also I don't feel that momentum of the CHF program has gone off the rails, quite the opposite. It feel like it's ramping up on all sides and that Mesoblast are putting forward a calculated approach to identify the highest risk patients, the patients that benefit the most (elevated inflammation), a common MOA and the most efficient way forward for each cohort based on the data collected from all previous trials.

    The most telling sign for me that may identify AA is still on the table for class 1 & 2 is that the most recent half yearly update still included the wording "LVEF may be a potential early surrogate endpoint". I note that the update was released post the most recent FDA meeting. Identifying LVEF as an early surrogate endpoint and its connection to improved clinical benefit only serves one purpose, to open up AA pathways. Essentially FDA agreement on this surrogate endpoint means AA is on the table. id be very very surprised this wording would still be included if the FDA has explicitly denied this as a potential option. I'm not saying it's in the bag, just that it's still being considered. This inclusion may seem insignificant, but it certainly shows Mesoblast intentions and may be a subtly hint for what's to come. Like you said im just trying to find the breadcrumbs.
 
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