Ann: Mesoblast Newsletter on Advanced and End-Stage Heart Failure, page-36

Hi @Treed,

With the information provided, imagine is probably the best anyone could do at the moment. I’m well aware they didn’t conduct the trial. That’s not in disagreement. Now let’s say the message from MSB was “we are doing our best to ensure a timely outcome but are not in a position to assert any control over the progress of this submission, but based on our duscussions with the trial team we are under guidance that they will begin submission consultationsy with the FDA in the first half of 2019”. Something like that conveys a lot information about the state of play. It sounds at a minimum more confidence inspiring, result may still be the same but they sound proactive at least. 

But that’s not what they said, MSB said in their announcement that they themselves will undertake the consultations with the FDA “In the first half of 2019, Mesoblast plans to meet with the FDA to discuss the pathway for approval of Revascor in end-stage heart failure patients for the reduction in GI bleeding.”, this puts the onus squarely on MSB to do better with their communication to the market. Words matter. The market has a confidence problem with MSB, they need to fix it. Are they misleading the market, no idea, but they could be leading it better. The announcement itself was a good start, building on that shouldn’t be hard.