Ann: Mesoblast and FDA Align on Key Items for Revascor BLA, page-67

On Monday 25th March 2024, MSB closed at $0.33c with 1.7m in volume
On Tuesday 26th March 2024 there was a price sensitive announcement advising that the FDA would support a refiling of the Ryoncil BLA, MSB closed at $0.48c or up 45.5% on 59.0m volume.
On Wednesday 27th March 2024 MSB closed at $0.495c up 3.1% on 60.3m volume
On Thursday 28th March 2024 MSB closed at $0.555c up12.1% on 30.8m volume
Then it was Good Friday and Easter Monday
Trading resumed on Tuesday 2nd April 2024, and MSB closed at $0.95c up 71% on 66.8m volume

The rest is history ...

When I read the announcement today, it was the same feeling I had on Tuesday 26th March 2024... except its Tuesday 1st July 2025 and we closed at$1.84c up 11.2% on 7.8m volume

If it plays out the same as it did the last time we got confirmation of a BLA filing, then the shorters will be working extremely hard tomorrow to stack the sell side and manipulate people into selling... they did remarkably well in 2024 where 60m in volume went through with only a 3.1% increase in share price ... they then eased up the next day ... market was tentative and thought the run was probably over.. and then over the weekend, FOMO set in and it exploded on the next trading day.

Lets see if we get a repeat, keep an eye on Monday ... could be a big day for MSB after a few relatively modest movements over the rest of this week.

Games aside, the fundamentals of MSB have never been stronger. The announcement today was extremely important, and allays any fears that the progress we've made over the past decade have somehow been dismantled by the new government. Few appreciate the deep history the Texas Heart Institute and Dr Perin have with the FDA, which started in 2003 and Mesoblast's MPCs really came into the scene with the release of the Phase II results back in 2015 if I recall correctly ... it's been a long journey with the FDA, and Dr Perin has been there alongside Mesoblast to bring this treatment to the patients who need it ... a nice video from about the 25 minute mark where Dr Perin talks us through that journey, and you can see the excitement in his face as I think he knows we are damn close to the first approval.

https://youtu.be/sqGcAvWsMSA?si=IBa2RsnAiqOAmo_D&t=1504

I've highlighted before why this AA is significantly de-risked compared to the Ryoncil BLA .. not only is it an accelerated approval, which means the bar for approval is a bit lower .. but we've also navigated and learned invaluable lessons by getting the first ever FDA approval in the US using MSCs ... and in contrast to the Ryoncil BLA, we have two large randomised well controlled studies to support this AA BLA ... it is never a sure thing, but I feel we are going into this approval process far far far far better armed to succeed than with Ryoncil, with the added history of supportive FDA interactions in the heart space.

On the backdrop of quicker approvals, as well as a significant unmet need that this AA would unlock by giving the FDA confidence in CMC/potency assays, efficacy and safety in an end-stage population, before allowing MSB to label extend into late-stage which is a much much larger market. Baby steps, but very lucrative steps even in these 'smaller' indications.

I can't believe we still have two big announcements this month to look forward to... we'll get some initial feedback on the adult SR-aGVHD label extension, but likely will need the official minutes before we get the details on timing / endpoints etc... and of course our first quarter of Ryoncil sales in the US, which has at least a few patients ... but how many more, all whilst the centre roll-out and payor coverage is still expanding ... oh 1st July today, mandatory coverage for the remaining lives ..

We can't be sure when it'll happen, but this is set for another leg-up and re-rate before it settles .. the potential upside is now undeniable with the confirmation of a second BLA application in as many years .. with a potential one for adult SR-aGVHD next year, and then CLBP the year after... is there another ASX company that has a chance for three more FDA approvals in the next 3 years... could do a panthers.. 4 in a row

watch for the FOMO / short squeeze .. @ddwn is getting the popcorn ready

Goodluck all