We are heading into the last week of an exciting August 2020.
We have two official dates in front of us:- PDUFA on 30th Sept
- DSMB completion of first interim analysis of Covid-19 ARDS in early Sept
PDUFA on 30th SeptThe ODAC approval recommendation for the first MSC product in the US was critical for Mesoblast, but really that's only for existing investors and well researched companies.
Mesoblast is still considered a spec stock and is largely unknown in Australia and even less in the US.
This is all going to when we get the first FDA approved MSC product in the US.
That's is significant news. Old news to us existing SHs, but new news for the rest of the investment community.
The due date is 30th of September, but the FDA approval for Ryoncil can happen any days before this.
First interim analysis of Covid-19 ARDSDSMB completion of first interim analysis of Covid-19 ARDS in early Sept.
What is early Sept anyway? The first week and maybe stretch out to the first half of the following week?
How can this be achieved unless the data is sent to DSMB by next week.
My anticipations
Those two events are independent - or are they?
I believe they are not independent and see the following events played out...
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.
I've may have gone one week early last week, but these are my thoughts for 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
13. Prelim final report and annual fin report
HOLD - the warp speed part of the ride to begin soon BTW - Some other big ticket items are also listed herehttps://hotcopper.com.au/posts/44627079/singleAnd please don't feed the trolls, put them on ignore!
Of course, it goes without saying - all the above is IMO
(20min delay)