Cell Therapy News/Articles, page-12475

I believe Dr Perin recorded this before they actually presented the data presented at the AHA, to the FDA. I believe after the FDA were presented with the AHA data, they then “encouraged” Mesoblast to do another analysis to find the highest risk group that would benefit from this treatment.

Typically you need two phase 3 trials for full approval, so what Mesoblast and Dr Perin may have sought from the FDA was primarily if the second phase 3 trial could use the 3 point MACE that Dr Perrin was referencing on that video. But they may have, or the FDA may have suggested that a single trial approval may be on the cards, if the data is “very persuasive”.

Which may explain why the latest analysis, about a month after the AHA is not only CRP>2 patients, but also ischemic and diabetic.

It’s a very high bar, so it is only by exception that it is granted… but it appears we are at least in with a chance. And if that doesn’t eventuate, we will be able to use the data from the first trial for potential approval if the second trial is successful.

But in any case, a partner for our heart program is extremely likely shortly after the FDA confirm the approval pathway.