From the AGM today...
First off, I think as a SH if you should make every effort to attend the AGM when you can,as you will get the information first hand and can get more colour from talking to management directly.
I went to the AGM today with low expectations and I came away with mixed feelings.
This is mytakeaway, with some inferring from my understanding. So if in doubts, pleaserefer to the published material/ announcements direct from Mesoblast. In anycase, anyone else who was there today can contribute or dispute what I'veposted.
PotencyAssay:
I've gotclarity on potency assay after asking SI to simplify it for me. The summary isthat we have two potency assays the original potency assay used in the P3 trialand inventory; and the new potency assay used in the P3. The FDA are happy withthe new potency assay (it's very detailed and have addressed their originalCRL#1 concerns) and have indicated that Mesoblast can use this for the adulttrial, but they want assurance that the potency assay used for the inventory isconsistent with the new assay. So if you like, the old assay is being refinedand new data will be provided to the FDA to back this up. This can getcomplicated and beyond me, but that's is my understanding.
The FDAhave now acknowledged that the Study 001 well constructed and executed trial -it met it's endpoints. So no more talk about RCT for kids!
When theadditional potency assay data is finalised, Mesoblast will discuss this withthe FDA prior to another BLA resubmission, whereby the expectancy is Class 1 (2months review) - as this is only potency data and no new clinical data
Adult GVHDTrial
Singledigit in terms of millions costs to Mesoblast. Likely to be single arm, butnothing is confirmed until they meet with the FDA again.
CLBP
Was pushedback a quarter potentially due to tight funding management.
Funding:
I've askedseveral times, but he held it very close to his chest. I even tried so we are"very very very" advanced now?
Mesoblastis on very good terms with Oaktree
Essentially,we have these three methods, it's up to you to assess which one we are going gowith:
1. CR
2. Monetizationof Royalties
3.Partnership $$$
4. Survivetill Ryoncil approval for kids
I don't want #1, as that's too dilutive.
#2 ispossible
#3 and #4 -who knows
... I was going to type more, but that will do for now.
Happy to answer any questions where I can
GL MSB'ersI'm still really hoping for Onwards and Upwards, but until the funding issorted out - I've got mixed feelings
BTW - AGMare great to finally meet the real people behind these HC names 
(20min delay)