Will not try to spin anything on these results,as it is what it is - a bad result, on top of a bad week.
Two questions need to be answered:
1. Why weren't we told that the endpoint was to achieve 43% mortality above SOC? It may be that we were and I had blinkers on.But if we were not, why? I would not have invested so much if I had known we had such a high bar that it would be very, very difficult to ever achieve.
2. Why did the patient enrolment demographic change between analysis 2 and 3? I accept that this may be out of the companies hands given they were not running the trial, but why wasn't a different enrolment criteria provided?
The issue it seems is that the science of Mesoblast is sound, and that the drug works - however, their trial designs for aGHVD, CHF and now ARDS does raise some questions.
From here, the best things to wait for is:
1. Whether secondary endpoints in ARDS is met, and whether Novartis bankroll a general ARDS trial.
2. CLBP Phase 3 results and partnership
3. Partnership for CHF which is expected "in the coming months" -
4. Outcome for aGHVD accelerated approval pathway
Points 2 and 3 seem most likely to see investor value.
Although I know some have been somewhat negative on the CLBP results, I do seem to recall that MSB are gearing up for a Phase 3 trial in Europe, so I am hoping that means the results are at least acceptable / pass to permit a confirmatory trial or otherwise. Hopefully that means milestone payments and possible extension into America.
As to CHF partnership, well SI and the team now have a lot more time on their hands to chase down a lucrative partnership for funding purposes.
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