Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-196

Repeating what I’ve said before, after following all the analyst conference calls in last two and half years, it’s clear that the recommendation for additional study was handled by Mesoblast and the FDA dispute resolution panel which was convened at Mesoblast’s request. These are higher ranking officials in the FDA. The consensus was that an additional trial wouldn’t be required before resubmission, and all that was required from Mesoblast were further meeting’s with CBER's review team at the Office of Tissue and Advanced Therapies, OTAT, for addressing certain outstanding chemistry manufacturing and control, CMC items, which included potency assay validation.

Silviu was very adamant about this point when asked by an analyst.

The FDA’s main requirement for resubmission was to ensure that Mesoblast’s manufacturing demonstrates consistency beyond what showed just in the phase 3 program, that all of Mesoblast’s commercial batches continue to show exactly the same potency and activity.

Apparently this has been completed and they’re very happy the results!

It’s now a 95% chance of approval for aGVHD in my opinion.

Within the next month or two I am expecting the following:

• CLBP Partnership announcement, which can take different forms however I expect they’re at an advanced stage and resubmission of aGVHD is what they might have been waiting for.

• CHF meeting with the FDA and possibly an Accelerated Approval. Just a matter of time now and as Silviu said can happen anytime in next 3-months, although I expect within April.

Please do not rely on the above as investment advice!