Thanks @aquazul, @dplane and @Reginald - maybe, I'm reading too much into this and hopefully all of it will come out in the wash very soon...
However, the language in yesterday's announcement is very precise.
It's not a BLA resubmission.
If it is not a resubmission, then what is it?
Yes, the FDA are a law unto themselves. But, they are still a bureaucracy and they will need to follow some procedures or guidelines. So which procedures are they following atm and where are we with Ryoncil? Any thoughts @stockrock@otherperspective anyone else?
I have no doubts that Mesoblast has been in discussions with the FDA and have followed "as guided by FDA", and with a bit of luck this may result in a quicker approval than a BLA resubmission Category 2. I'm curious though why this came out at the 11th hour and has not been explained properly by Mesoblast. If this filing was a pre-requisite to the actual BLA resubmission, then why wait till now?
This is certainly a change of direction from the Ryoncil BLA resubmission that SI has flagged recently "Remestemcel is in line for aBLA resubmission, which we expect to be filed this quarter"
I'm looking forward to more news. As I've said, I may be reading too much into this and hope you guys are right. In the meantime the SP needs to keep nudging up from here
GL MSB'ers
MSB Price at posting:
83.0¢ Sentiment: Buy Disclosure: Held
(20min delay)