I've just came back from a bike ride with my family and now...

I've just came back from a bike ride with my family and now enjoying a beer or three after what has happened this week!

Second week of August and wasn't that an engrossing week?
Park the SP gyrations aside, it was such a significant week in what is a significant month in Mesoblast history.

We may even get the ODAC approval recommendation for the first MSC product in the US.
How can any SHs not be excited by this?
Lots of committed MSB'ers stayed up and tuned into what started out to be a very dry FDA process, into a very exciting process, filled with loads of emotions - with the voting at the end and we were still unsure what the answer would be.
But, 9-1 well that was as close to unanimous as you can get
It was definitely the first ODAC review for me, and I'm glad I've stayed up with the rest of the MSB'ers lunatics
We've spoken plenty about this already, but I don't think there were any that tuned in and didn't enjoy the event.

I'm a proud MSB'ers and I'm happy to wear my feelings on my sleeve.
We have been vindicated with our belief in Mesoblast.
So now there's not too much to be stress about, just let SI and team lead us forward - and the SP will follow

So where to now?

Ryoncil approval will pave a way for the FDA to extend the label for Rem-L Covid-19 ARDS.
This is the path of least resistance and will allow the FDA to stand up and say that they have an approved product that has gone through a very thorough and safe process.
The stage is set - get on with it FDA!

This will also create a great MOAT for Mesoblast; as we are that "lucky" company with years of science behind us
It will be hard for other companies to get an FDA approved product without the long, arduous and costly FDA process.

So what can happen next week?
The 90 patients interim data is likely to be sent to DSMB, they need this in order to provide a conclusion by early September.
Possible partnership for ARDS as well, as there's a fair bit of setup to be done. There's no time to waste.
I'll give two weeks for FDA to approve Ryoncil - they need to do this quickly to allow for Covid-19 ARDS label extension
So bring on those announcements!

August 2020, maybe news about:

1. ARDS patient enrolled updates (maybe at 30% or 50%)
2. ARDS partnership announcement
3. ARDS data sent to DSMB for review
4. ODAC review (and news leading up to ODAC)
5. FDA approve Ryoncil

6. Leaks from doctors, family & friends in COVID-19 ARDS trial (this has started already, but likely to be escalated)

7. More analysts updates (regarding above)
8. CHF readouts
9. CLBP readouts (only one of #7 or #8, for this month. Yeah, upcoming is not imminent, but the expectations also has not been set to Q4 either)

Potentially, but unlikely for this month:
9. Discussions of Pediatric multi-system inflammatory syndrome PMIS
10. Crohns updates
11. WH announcement ontherapeutictreatment - surely Gilead's treatment is not enough!
12. Quarterly reports

HOLD - the warp speed part of the ride to begin soon

BTW - Some otherbig ticket items are also listed herehttps://hotcopper.com.au/posts/44627079/single
And please don't feed the trolls, put them on ignore!


Of course, it goes without saying - all the above is IMO