Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-317

Mesoblast are entitled to announce the results in any way they choose, and they appear to have received a better market outcome on the release of these results compared to the CHF trial. So SI has done a good job today.

however the FDA is still an unpredictable beast, and ultimately they will decide if these are good or bad results. I think the pain outcome is outstanding, but the FDA requires function to be assessed along with it for a reason... and from experience, we know the FDA can be very stubborn when it comes to approval.

having a further read into the opportunity to accelerated approval in the US for reducing opioid use- I’ve yet to find any pathway for accelerated approval. All I can find is FDA providing guidance on endpoints they would deem approvable.

media is going to paint a negative view on Mesoblast ... at a glance, the Covid trial did not complete... CHF and CLBP failed to meet their primary endpoint... and Ryoncil was initially rejected by the FDA. That’s 0-4, not a great look.

but as highlighted in another post, there are many positives that could lead to approvals, partnerships and short term cash... it’s just the Mesoblast way.. always doing it the hard way!

goodluck all