Ann: Annual Report to Shareholders, page-13

Traditionally the route to FDA approval for CLBP has been a composite measure of both pain reduction and increase in quality of life score.

what Mesoblast achieved was outstanding reduction in pain, which translated to significantly lower opioid use, but no meaningful improvement in the quality of life score.

So rather than needing to twist the FDA’s arm to argue the quality of life score is no longer relevant, Mesoblast and the FDA could be working together to pivot the results into the new Opioid sparing route of approval rather than the traditional CLBP.

Meaning the results generated thus far could either be used as a surrogate for accelerated approval or as data which could be used for approval if a second phase 3 trial using opioid use reduction/abstinence as a primary endpoint, thus eliminating the need for a quality of life score endpoint altogether.

Both of these outcomes, if true, would be massive wins as composite endpoints are notoriously difficult to meet, so finding and agreeing with the FDA that a single endpoint which is strongly linked to what your treatment can achieve makes it a much more relevant and easier trial to succeed in.

Could explain why in his letter he didn’t talk about the pain reduction, only the opioid sparing benefits … but no matter what, he said the guidance was coming shortly, which he didn’t say about any other FDA meeting or feedback… so my guess is that we will get this before the AGM.