@ddwn I couldn't help myself 
but free time is currently very scarce, but thankfully there is very little need for me to spend too much time researching Mesoblast any more ... I am spending any spare time researching other stocks and building positions in those. I was able to grab some more MSB cheapies in the high $1.50's recently, a bit naughty as I have plenty already.. but it was simply too hard not to buy more at those silly prices!
It's somewhat exciting to again be talking about a potential BLA .. and to remind everyone that for the FDA to approve a product, it needs to tick three big boxes.. CMC/manufacturing, effectiveness and safety.
Now one of the key differences between the roller coaster we experienced with Ryoncil's BLA, which got rejected twice, is that the proposed Revascor BLA will be supported by two large randomised well controlled phase 3 studies... as opposed to a relatively small, single arm phase 3 study which eventually got approved after the third attempt!
The fundamental concern with Ryoncil's BLA is that it was a small single arm phase 3 study, which made it very difficult for the FDA to sign off on CMC and potency assays .. .and to conclude that it was an adequate and well controlled study, which is what is required for FDA approval.
That should not be a problem for Revascor, with an abundance of data derived from two large adequate well-controlled studies .. it should not be difficult for Mesoblast to find the data required to satisfy this step - however what the FDA wants to see will be clarified in the minutes of the Type B meeting and Mesoblast can then confidently proceed to compile such data.
Oh and we've already passed a manufacturing inspection for Ryoncil too... another de-risk ahead of this potential BLA!
Safety should be a breeze, with a clean sheet. No serious adverse effects recorded to date across multiple clinical studies.
And effectiveness will be backed by strong data across two large phase 3 clinical trials, which was enough to excite the FDA into offering up an accelerated approval pathway! Not to mention that means the hurdle for effectiveness is actually lower than normal, meaning we can use surrogate endpoint which only need to be reasonably likely to predict a clinical benefit, which compares to a full approval which requires us to meet an endpoint that clearly results in a clinical benefit.
Now I'd very much welcome another ad-com... but not having one might be a sign that the FDA don't feel they need it.. but they may be compelled to have one given it will be a first in class treatment for heart failure ...
CLBP progressing in the background, Ryoncil Adult trial progress update is finally upon us, IBD and other label extensions lurking in the background...
Cashed up ... multiple irons in the fire, approved product.. sales ramping up ... quite frankly never been in a better position.
Goodluck all
(20min delay)