Ann: DMC Completes Final Review of Phase 3 Heart Failure Trial, page-10

Contrary to some of the comments earlier in this thread it seems that the role of a DMC and relationship to MSB is not well understood. The DMC is absolutely and completely independent of MSB.

@dontfollowme The DMC does not provide detailed analysis or unblinded data to MSB therefore MSB has included in it's announcement exactly what the DMC has concluded and reported to MSB - the trial should continue.

The role of the DMC is to advise MSB of three things.

The primary role is to ensure patient safety during a clinical trial. The DMC has concluded the trial can continue as Revascor causes no additional harm when compared to the placebo group. This is unsurprising as Mesoblast's MSC technology has been shown to have an outstanding safety profile in every evaluation made to date.

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.

@timothy TM Lim, the DMC has never commented on any of the end points (primary/secondary or otherwise) - happy for you to correct the record if you have the factual information. Based on MSB's previous studies we can also be certain there are not 270 positive responders out of 270 treated patients - I wish that were the case then the trial would have been halted and we would all be rolling in money!

@mgavoca - "highly probable the results will be significantly positive" cannot be inferred from the DMC recommending that the trial continue. You are by all means allowed to hope that but the DMC by allowing the trial to continue are not telling you anything like that.

The tertiary role of the DMC is to assess futility - in layman's terms "Is Revascor a WOFTAM"? Fortunately for MSB investors the DMC have been able to concluded in both the interim and final analyses that the trial can continue.


GLTAH and watchers - Have a great Xmas break everyone and looking forward to a prosperous "MSB game changing" New Year.