Ann: Meeting Requested with FDA on Revascor Accelerated Approval, page-64

Hi@col69 It has only been 24 hours since a few in the market became aware (via details publicly available on the internet) that Mesoblast has just secured payer coverage from United Healthcare for Ryoncil from July 01 2025….a huge development worthy of an announcement on its own in my opinion ….and now we have this widely anticipated pre BLA meeting announcement on cardiac.
First any idea that they have had a pre BLA meeting on HLHS already is nonsense. So why have they changed the order of their accelerated approval pre BLA submissions ? Well, let me speculate with you…and i know you like to use the wink button. Maybe the answer is lying in plainview right in front of you ? Ischemic Heart Failure …Has Silviu forgotten to mention the end stage heart disease with an LVAD bit ? How careless of him
The size of the ischemic heart indication dwarfs the 2000 babies in the USA diagnosed with HLHS each year.... and whilst it would be great to receive a voucher worth circa $100m for putting HLHS first…the Board must have concluded that it would be economically illiterate to prioritise a small orphan indication over a blockbuster which might easily attract a global partner .
Any potential partner in ischemic heart disease would obviously need to know the monetary cost ,clinical endpoints and timescales of financing a confirmatory trial and that the FDAallows the chosen potency assays in writing, after all the kerfuffle with steroid refractory acute GVHD. Put simply, the guidance Mesoblast is seeking from the FDA could be worth many billions to the Company…dependent on the guidance it receives .







I suspect Silviu has chosen his use of words extremely carefully in today’s announcement. You have all been warned..but once again the incomprehensible drift in the share price has distracted you. When the minutes become available from this pre BLA meeting …it might end up constituting one of the most important pieces of the puzzle in reaching regulatory alignment for the whole ischemic disease franchise

As for the data available on the clinical trials website for CLBP, an old warhorse like you must appreciate the Company only gives periodic updates. Whilst i doubt the Company has reached its stated goal of securing 40 locations …you would be unwise to assume they have not made significant progress towards achieving that goal. I suggest you wait for the next periodic update before being too critical . Personally, i expect full enrollemnt of the pivotal CLBP phase 3 around the end of Oct/early November. Now wouldnt it be great if that represented the opportunity to file for another accelerated approval opportuniuty ? this time in those who have been prescribed opiods for chronic lower back pain . Apparently it is the cause of approx half of deaths in the USA from opiod overdosing. Pres Trump seems pretty fired up over the use of fentanyl and opiods …dont you think ?

Well thats enough winks from me to last a whole year…but you get the point

I believe todays announcement serves as the countdown to something very very important in the Mesoblast calendar. Treat that as you may ! OP


Please do not rely on the facts or opinions expressed in the above post when making an investment decision .