Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-566

Thanks for the mention.

Two key points stick out to me: 1) the fact that these pre-specified groups met the primary endpoint (or came painstakingly close), and 2) at the 17 min mark of the webcast SI mentioned they have made adjustments to these groups for multiplicity factors, which you would only do for primary endpoints.

So this tells me that for these two pre-specified groups (group 1: CLBP of less than the median onset of symptoms, and group 2: CLBP baseline opioid users) the primary endpoint was met and therefore only the secondary endpoints that fall under those two groups can be considered for approvals. The primary endpoint was only just missed for group 1, but it is still close enough to be considered for approval. The treatment also exhibits dose-dependent effects, which is remarkable considering this was a randomised, double-blind study.

The "pre-specified' nature of these two groups is vital and runs counter to the data mining criticisms that some have mentioned on this thread. Also, since they are pre-specified, this also means they've already held talks with the FDA about them, so the FDA is aware that they were specifically looking at these groups. The only question is, what was discussed and what was the FDA's guidance in relation to these two pre-specified groups. Only Mesoblast and the FDA will know.

Two slight criticisms is there's a slight overlap in CI intervals and the effect size is less than ideal, but these are minor criticisms considering this was a randomised-double blind trial and that you're dealing with chronic pain and an opioid epidemic.

@Moneymaker1979 I think one of your earlier comments may have been directed at me about why I don't hold. I am a deep value investor, which is what attracted me to MSB in April (and by extension hotcopper). I considered reentering MSB yesterday, but decided to stick to my original plan of buying back into a different company, although I will keep monitoring MSB. I think MPC's hold great value and yesterday's results reaffirms the long term hold strategy for most on this message board. Will MSB get accelerated approval? Who knows, but IMO they will land some major partnerships within the next 6-12 months for both CLBP and CHF. I expect a CR in August/September for an additional P3 trial for aGvHD, which is unavoidable in my opinion. Overall I think short sellers were expecting a trial failure and for the debt to start being repaid in March (which got pushed back to 2022), so it turns out the short sellers were wrong and I expect them to start covering.

All in my opinion, not advice, DYOR, GLTA