Ann: Ryoncil Commercial Launch Update and Product Pipeline, page-185

Hi @stocksa,

re your claims that Mesoblast management, in the slide deck you referenced, were:

" outlining preparations that are and will be put in place by the expected acceptance by the FDA on 7th January 2025"

it seems to me that you choose to define the word "launch" as the very moment that Mesoblast received in the mail any form of approval letter from the FDA for RYONCIL i.e. regardless of the post-marketing and other conditions of approval imposed bythe FDA, or commitments on approval, and regardless of the need fpr Mesoblast management to communicate those terms and conditions to Mesoblast's employees, consultants, CDMO (Lonza), insurers, PBMs, trial clinicians etc.

You also don't seem to give any weight to the fact that the words "Go to Market" appear in both the pre-launch and post-launch sections on the slides you've posted. Your assertions indicate to me that you believe that "launched" is synonymous with "approved".

Why would that be the case? National Drug Codes which must appear on the labelling for the approved product hadn't even been issued, nor could they be issued, pre-approval.

Can you point out to me anywhere in any public statements by CEO itescu where he actually said what you are claiming? Or where he said the product would be completely and definitively "launched" on or by 7 January 2025?

Could you also explain for me - as unfortunately I didn't attend the AGM - why 'label extension strategies' were preparations to be put in place by 7 January 2025 i.e. at the same time that Mesoblast management were talking on the same slides about there only being a "Potential Approval" from the FDA by that date (see Slide 19)?

Cheers