@Naughty Morty“The secondary role of the DMC is to halt a trial...

@Naughty Morty
“The secondary role of the DMC is to halt a trial when there is overwhelming evidence of efficacy. The DMC has concluded that Revascor has not met this standard. This is also unsurprising, the expectation is that patients will have a range of responses to Revascor as MSB has previously demonstrated.”

Everything you say is entirely sensible and normally valid.....however, it is my understanding, having asked the question myself, that as DREAM HF trial was the first major US phase 3 trial in a completely new class of stem cell therapy...Mesoblast agreed with the DMC/ FDA before commencement, that they would continue with the trial regardless of whether or not there was overwhelming evidence of efficacy . Indeed i think i might have already posted about this some months ago. Just to be clear, this does not infer anything other than the normal rule does not apply...we could still get an average result or an amazing result or somewhere in between. The function of the DMC was to measure safety ...and efficacy at pre agreed levels on a Bayesian modelling of posterior probabilities. I am not a statistician but i would have thought that the last test would have applied actual methodology on a complete factual data set...thus implying extremely low risk of error ?....which is why i think it is so encouraging from a futility standpoint.
Just to be clear, Mesoblast was allowed by the FDA to be unblinded just one time for both efficacy and safety...to see the interim futility test results in April 2017. At that time I believe only approx 25% of non fatal MACE had occurred. They have not recently commented on this information, but you may wish to draw your own conclusion as to why they continued on with the trial. Indeed i believe the interim futility test was a vital component in helping persuade investors to continue financing the project at the time. I did post a link from a trade magazine where an analyst who previously had a corporate relationship with Mesoblast, published what he believed to be the pre agreed hurdle rate for minimum level of efficacy..it was a high percentage but perhaps not in the overwhelming category. What was so encouraging , is that the interim futility test for efficacy was achieved even though the tolerances at this early stage in the trial would have had to allow for a wide variety of future possible outcomes. This means that there is always a much larger margin of error , in “early look” futility tests which can lead to false negatives for many clinical trials which it was later established should have continued.

I think your very valid assumption has wrong footed many a potential investor and may well have been overlooked by the shorters. I am afraid that when it comes to FDA discussions this Company is not very forthcoming...i understand the good reasons why it has to be this way...but it has led to many misunderstandings of trial protocols with its investors. So fingers crossed for “overwhelming efficacy” .....just like the phase 2 trial result !!!

Lastly, i just want to reiterate that for the DREAM trial to end with slightly less MACE events than originally suggested and towards the end of the period suggested (even after adding largely Grade 3 patients since the interim futility test to further enrich the trial number of outcomes) is very very reassuring....in my non professional opinion of course. OP

DYOR Do not rely on facts or opinions expressed when making an investment decision.