My kids woke me up with ''pinch punch for the first of the month" this morning, I can't believe we are into August already, but here we are.
What a weird year!
Mesoblast Chief Executive Dr Silviu Itescu stated: “Remestemcel-L has two imminent major milestones, the interim analysis in the ongoing Phase 3 trial of remestemcel-L in COVID-19 patients with acute respiratory distress syndrome and the FDA advisory committee panel review of our submission for potential approval of RYONCIL™ (remestemcel-L) in children with steroid-refractory acute graft versus host disease. Together with the upcoming Phase 3 read-outs in chronic heart failure and back pain, these key milestones will take the Company into the most significant period in its history.”
Onto Mesoblast...
Yes, I was hoping for an exciting June & July - it didn't come! 
However, August is certainly is gonna be a significant month in Mesoblast history.
We may even get our first FDA product approval!
How can any SHs not be excited by this? 
Looks like the SP is primed for further advancement, and all is needed was some surety... and guess what with the recent quarterly we have two immediate dates to look at:
- ODAC date on 13/08/2020
- DSMB in early September 2020
Each of these dates are significant.
Leading into the 13th of August, we'll get some more news and likely analyst updates.
Even without these news, the surety of the dates, written in black & white; which IMO will drive the sharts to close most of their positions.
Rogly 34.5m shares. That's a lot of volume, especially in the face of significant company news, when hardly anyone wants to sell.
So the unwinding of short positions will escalate in the coming days and will push the SP beyond our recent high of $4.50 or so. I'm not going to put a ceiling on this, but it could be a nice number before the actual ODAC date
In conjunction with the ODAC date and sharts closing their positions, we'll get compound news with Rem-L Covid-19 ARDS.
In order for the DSMB to be confident to set an early September 2020 date, MSB (or NIH) must have informed DSMB that the data for the first interim analysis is almost ready.
So, I'm going out on a limb and give MSB (or NIH) the next two weeks to announce that the data for the first 90 patients are sent to DSMB.
What sort of new articles and excitement is this going to make? Will the WH have a say?
How will this not compound the ODAC date?
Now given the urgency of the pandemic, will political pressure be put on FDA to approve Ryoncil as quickly as possible?
Why can't this happen in August?
The PDUFA action date of September 30, 2020; that's the last day for the approval, but it can happen before this date; and IMO it can happen in August!
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 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 on therapeutic treatment - surely Gilead's treatment is not enough!
12. Quarterly reports
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/single
And please don't feed the trolls, put them on ignore!
Of course, it goes without saying - all the above is IMO
(20min delay)