Mesoblast CC Transcript 31/8, page-25

So @col69

aGVHD

Efficacy and safety now have been ticked off, it is just now proving potency consistency on each lot from current batches vs previous trial batches? A question that seems missed is whether this data was provided with our BLA resubmission or is still outstanding. From SI and Krause I believe we have provided part-information, and the rest will be provided at AA.

Best part of the call was below:

One of course was the favorable results of the inspection, but the other important thing to take note of is that, the CRL did not question the efficiency of the product as was demonstrated in GVHD001, as had been the case in the previous CRL.

Is it correct that if this information is provided and satisfies FDA, does that mean in mid-September we could have approval for pediatric and adult aGVHD?

Overall, seems like we are 180 degrees different to when we first heard of CRL. I still cannot consider a possibility where we escape a trial, but the above gives some hope that we may be a lot closer than previously thought a month or so ago.

CLBP If we are recruiting patients in October onwards, then that would be massively positive for the SP. Particularly given the confidence SI and others seem to have in this indication, especially now we have control arm indicated, along with both primary and secondary endpoints.

Interesting that both partnerships and royalties was mentioned as ongoing. I do not think they will do a CR to fund this P3 but a royalty deal. Which hopefully they are holding back finalizing until after the mid-September meeting, because if it turns out to be positive with FDA than that could affect the $$ value of the partnership.