Ryoncil: ODAC/FDA Meeting Discussion, page-1862

I may well be wrong here but this is how I saw things. But I was asleep between 2-5 am I think, or in a daze not sure.

Here is the summary of the last few days.

• Mesoblast explains why Remestemcel L works and works well.
• FDA (doing their job, give them a break) plays devils advocate and has some concerns over various matters.

The questions broken down in all its basic form are;

1. Is Mesoblasts data accurate? FDA not sure.
2. FDA asks we have questions, what do you guys think? (to the panel)
3. Fact of the matter is, whether we are right (FDA) or Mesoblast are right, does it matter because the endpoint is achieved, it saves lives?

The panel decides, well mesoblast has a lot of experience here, and the endpoints are great for kids. It's clearly safe, it clearly works, but it's not 100% clear why. But we don't think the last reasons is enough not to go forward. It works, how or why, really doesn't matter, because it's safe.

So here is the next questions,

1. AFR article timing, why, and who? (you know what I mean)
2. How does this now look for Covid? the points made today make it pretty clear Reme is going to be a go for Covid
3. The most important question, how much do you load up on when it opens?