Ann: Mesoblast Update on Chronic Low Back Pain Program, page-148

@Pharmagang

Silvui did in fact say that they were looking at a 12 month primary endpoint for the confirmatory trial last year... which has been supported by the phase 3 data read-out.

I am also looking back at my notes and have something on MSB funding the EU trial, using the upfront cash that Grunenthal would have paid to MSB if the EU trial were to go ahead.

Looking at the ASX announcements, there is no specific mention that Grunenthal would fund the trial.. only on the upfront cash they would pay, as such I assumed MSB would be using that upfront cash to pay for the trial. US$30m sounds about right for a relatively small scale 12 month CLBP trial in the EU.

Can't access the investor update in Sep19 when the Grunenthal partnership was announced to confirm my understanding, but if Grunenthal was going to pay the upfronts and also fund the trial.. I would have thought that would have been specifically mentioned in the key partnership terms.

In any case, the US trial will need to be funded as the Gruenthal partnership would not have encompassed a US trial to be funded. As such, this upcoming FDA meeting, if positive, will lead to a US partner and more upfront cash. Given the opioid sparring capability of this treatment, it is going to make it a highly sought after treatment in the big pharma space.

we could end 2021 with a new partner in the US, more funds and the confirmation that a 12 month phase 3 trial in the US for CLBP for full approval (maybe even a sneaky chance of an accelerated approval application)... still have COVID ARDS, ARDS, and CHF FDA outcomes to look forward to... all in the space of the next 6 months...

investment case is rather simple... if the FDA gives a positive response to any or all (CLBP, COVID ARDS, CHF) then today's share price will be eclipsed in 2022... and if the FDA rejects all the data.. then it's an easy decision as an investor... gotta know when to hold them and when to fold them. Important thing is that we will know by the end of 2021.

goodluck all.. catch you when the FDA COVID ARDS announcement is made in a week or two...