Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-796

Re "why not chuck it all [ existing RYONCIL stock] in the bin" and "it makeszero sense to argue...with the FDA" etc, I 've got to say that one stopped me for a minute. I wasn't sure if you were pulling my leg.

Then I realised you were serious, so let me say first up that I really have absolutely no idea why a MSB investor would say that. Everything to do with a BLA is an application over the details of which a sponsor will spend millions and millions of dollars just so that they can have the opportunity to argue for a marketing approval from the FDA.

...ok, a couple of last thoughts for you to chew on:

1. EAP clinical personnel are out there in the US right now & they're just praying that they can get some of the RYONCIL stock out of that bin you mentioned.

Do you know why? Yep, it's because they think it works. So do their patients. Think about that for a minute.

2. Guess what! The FDA agrees with you - they also would like to see potency demonstrated going forward i.e. yep, completely prospectively - remember, it was actually their idea to wait for it from a new trial after their own highly qualified ODAC practise experts voted to get RYONCIL out to the front lines ASAP.

But no. The FDA - they're regulators y'see, & they live in a perfect world (unlike you and me and MSB). It's a world where everything happens at the time they'd like, in the order they'd like, with the evidence they'd like etc. You get the picture, I'm sure.

So now the easiest thing for the FDA is to just chuck EVERYTHNG - INCLUDING THE ENTIRETY OF MSB-GVHD001 DATA in the bin. Have MSB spend another AUD10m. With no guarantees of the outcomes. How's that for a thought. Have MSB go back to square one.

Bonus: that would give them some extra time to deal with other applicants. You know, give those other guys approval before us. Surely we'd be OK with that, eh?

Wait for a new trial.
Wait for the new stock to be manufactured in future etc.
Wait for the potency to be demonstrated prospectively against trial results
Just wait.

See any problems with that being the priority for MSB? As an MSB investor looking for ROI.

3. the FDA haven't given MSB the little piece of paper yet that says that they're now happy. Nothing's agreed in their world until everything's agreed (by them). Remember what Dr Krause told the MSB Earnings Call: either we 'demonstrate' the resolution of their CMC issues to them, or MSB has to wait to 'demonstrate' it from new trial results.

We don't get to say to them 'hey, now we think you guys are close enought to know the answer so give us the prize'. Doesn't work that way. Instead we have to generate new data (which they haven't seen before) to close whatever their "kowledge gap". Until that is done completely i.e. the FDA gives us the piece of paper that says its OK to sell RYONCIL, Mesoblast will not throw away any opportunity. So that means we still have to resubmit the BLA modules. They still have to consider it. They reserve their right to serve another CRL on us.

It would be criminal IMO for any officer to just throw away our best short-term opportunity for approval & pin all mesoblast shareholders' hopes on a future trial off in the never-never.

OK, then finally you had a couple of things to say about management. In my view your comments were misconceived. Maybe you were tired.

There's no hubris in management here, in my opinion, much less arrogance in mitigating/ avoiding multi-$M costs, avoiding unecessary risks, maximising the chances of regulatory success and seeking to complete this vital asset acquisition early for the benefit of Mesoblast shareholders as a whole.

Food for thought.

Cheers