CYP Price Target post MSB FDA approval., page-168

I'm glad you found it. Hopefully didn't take you too much time since ypu only just posted it on here 8 days ago.

So, what are the steps for the FDA to grant label extension?
Is it as simple as sending in a letter?
Or does it require a form to be filed?
If it does require a form, would you need to attach additional evidence?
If so, would that be clinical or real-world evidence?
In either case, would they want to see "old" or "new" evidence?
If it is old evidence, would you consider the existing clinical evidence to be supportive of a label extension even through neither Osiris nor Mesoblast deemed it good enough to pursue the adult patient group, or even submit it in either Canada or New Zealand, where the drug was already approved.
If it is new evidence - in adults, not children - has Mesoblast published such evidence that would support the label extension since it hasn't been on the market to generate real-world evidence?
I am aware of an SI comment about adults treated via EAP, yet nothing has been referenced anywhere other than his comment.
There hasn't been an approved therapy in children with SR-aGvHD, there is however (a bad) one in adults - would that make things easier or harder to get label extension based on the old P3 trials you think?

It won't cause any delay for CYP's P2 trial in HR-aGvHD. But keep repeating it and reposting the same old screenshot. Maybe you can convince yourself one day.

Next quarterly will hopefully see a healthy increase in recruitment numbers, at least based on the CEO's recent comments in presentations. Lets wait and see if his interpretation of the numbers is the same as ours.

Regarding the presentation, I can see why KK prefers to mention the T/O offer to be $2 per share, rather than a subsequent MV at the time of $200 million. Fully diluted today, that would equate to less than 80c per share. I know, progress has been made since then - except, we no longer have a sub-licensee and whilst now completed another P1 trial, so far no new one in sight.
The time to be overly picky when it comes to deals is over, has been for years actually, especially when you do CR's at discounted prices. Stop "ross-ing" us around about the vigorous engagements, and get a deal done to finally create value for shareholders again, rather than issuing even more free performance options for met KPBSIs in case of an early exit strategy.