Ann: Mesoblast Maintains Momentum with FDA, page-45

More than 20 centres onboarded - sales $$$ will come - ticked As per projected roll out advised April 29- so we are on track,
Good news on Rex-L BLA - ticked Detailed minutes required for a partner to commit is one possibility.
Good news on adult trial to come - ticked This is happening same week that the minutes come out first week of July.

Can someone remind me the Sharts exit plan again? If Sharts were planning, as just advised again, to exit pre sales update or were
Now get on with burning those Sharts! expecting dismal sales. That is no longer the case- they now have until first week of
July to exit.


change of language below- broadening the scope- chronic gvhd anyone?
“We are very pleased with the momentum of interactions with FDA on both ourcardiac and GvHDprograms,” said Mesoblast Chief Executive Dr. Silviu Itescu. “We are also encouraged by the strengthof the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payorcoverage exceeding our expectations in the ten weeks since commercial launch. We will be providing anupdate on sales of Ryoncil® in our quarterly activities report at the end of next month.”

My take - sales are not strong, any strong numbers would have been updated. But when he updates at the end of July for April May June I bet you that July numbers get a mention. Why? Probably closer to 300 million coverage , 25 centres on boarded, Full medicaid coverage.


Remember that Japan rolled out Prochymal not Ryoncil when considering market adoption.


Total projected market annually was 375 patients.

50% of those patients were in the 15 largest hospitals. Another 30 % of patients in the next 25 hospitals. 40 centres cover 80% of patients.


We will be at 20 by the end of June- mind you if my kid was crook I'm heading to an onboarded hospital before you can say Remestemcel-l.

The pool at the moment has just reached around 130 patients or 2.5 a week. Why that number- 375 total pool- 72% insurance coverage, only 50% of patients hospitals onboarded- still to add more kids via medicaid.


In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adultswith SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical TrialsNetwork (BMT-CTN), the objective being to extend the product’s label from children to adults with SR-aGvHD.



I note the bleating of the sheep on here- same baa baa baa every time they post.


With the Ryoncil rollout well underway the team is readying itself for the next stages of growth. Where do you reckon the poor bastards who will be participants in the adult Sr aGvHD trial are located? In the same damn hospitals we just onboarded!!!!! Lets see - 1000 adult patients per annum- 50 % probably in the hospitals we have onboarded- apart from dedicated children's hospitals. That's 500 or 41 a month and we need to have around 70 patients in the trial that meet enrollment criteria. With a 28 day response endpoint. Not my area of expertise but extension of the label could happen rather quickly.


It will cost less than 10 million bucks to complete the Adult trial. Extending the label to a population pool of over a 1000 patients or to recoup trial costs- less than 10 sales to adult patients. It's not too hard to work out whether to have a go is it? 1000 times US$1,300,000 equals a lot.



I'm disappointed we have not been given a sales update, but for now we appear to be between 1 and three patients a week. - It makes sense to wait until the wheels are truly rolling- even the announcement mentions momentum. Big news will come before the quarterly on the 31st July , before the end of the second week covers early July , so the 11th. How fast can we get the label extension? Faster than the AA for CHF.




I'm amused that one extra patient a week is around US$67,000, 000 in sales per annum. Adult market is 20 a week.




Stop asking for a sales update- pay attention to the roll out details- use your noggin- listen to your mother- go clean your room





Reg