GvHD Lodgement, page-3

A - Based on my reading, this is my understanding
JCR intends to file for marking approval JR-031 for marketing approval CY2H14.
Milestone payments to MSB CY1H15.
Launch and royalty revenues GY2H15

Also listening again to the Q&A session (Aug 14 Webcast - still available on website) , Maxim raised a good point . JR-031 will be filed under the "old " regime.

Some of the SI's comments (to the best of my summary notes) were as follows:

"If approval is granted , it will be a full approval. Therefore on the basis of this Product we have rights to develop/expand the label across other application. Therefore we can look at Crohns Application in Japan where we have Substantial data in support of the Application already. In November 2014 , the specific guidelines will be released that will provide a framework by which Phase 2 Safety trials might suffice for conditional approvals of product and what kind of post marketing requirements they'll need to be to have definitive products approvals. At Mesoblast we expect our Tier 1 & Tier 2 products will potentially be available for accelerated approvals and launches in Japan.... once we have this Definitive regulatory Framework in place".

Worth having a listen to .

Other comments noted included ; how good the r/ship is with TEVA and how the trial is actively recruiting , ongoing and SI's excitement by the way its currently going.

Please DYOR and good weekend to all.