There's a few things that I've taken from the presentation yesterday, but the most immediate items are:
- Independent DSMB has set a review date of early September for first interim analysis of the Phase 3 trial fromthe first 90 patients after they have all completed 30 days of follow up
- Rem-L: Lifecycle extension strategy
Firstly, I have assumed that to get #1 above, a public statement would have been announced by Mesoblast that data has been sent to DSMB already. But, in the absence of this announcement, I'm now assuming that the DSMB has already got their data, as SI has said the data for the first 90 patients after they have all completed 30 days of follow up is expected to be completed at the end of August.
Secondly, I have assumed that the path of least resistance for the FDA is to approve Ryoncil first for aGVHD and then extend the label for Covid-19 ARDS. The slide below is confirming this view, as Covid-19 ARDS is part of the extension strategy.
So what does this mean for the SP?
Early Sept can be as soon as Tuesday next week, the question is what do you want to do today? What is your position?
Are the professional shorters going to hang on and wait for these news or do some break ranks & close their short positions?
Also, in order for Covid-19 ARDS to be extension of Ryoncil, then Ryoncil must be approved much earlier than 30th of Sept PDUFA date.
So again, this could be as early as next week.
Tick tock tick tock.
My guess for today is that we'll test the yearly high again.
What I've seen previously is that when a high is tested and the SP pulls back, it takes a day or two for the high to be tested and surpassed.
So why not today and make it a green Friday.
Again, I don't want to put a ceiling on the SP today.
As if the yearly high is breached, then who knows where it will close
Of course the professional sharts will put up a fight, but resistance is futile!
So much is happening guys.
Enjoy the ride MSB'ers and HODL
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