Hi
@dachopperAgreed about the new release spec too. I'd been absent-mindedly thinking for about 18 months now that the EAP275 lots might be the most likely to form part of the needed reference materials for remestemcel-l release testing purposes.
But it's not my field, so I very much appreciate your comments.
I've been following this & researching the potency assay angles for IL-2 Reg alpha for a while, ever since the below exchange during the AM session at ODAC in August 13, 2020 in fact:
and then CEO Itescu's clear as crystal blueprint for how MSB was going to fix it:
This correlation went completely under the radar at the time, as I recall.
And a lot of HC posting time was then spent focussed on TNFR1 - the downrampers & shorters had a field day.
And when CEO Itescu later in 2021 and 2022 referred in conference calls to revision of the potency assay(s), the connection still wasn't being made by those trying to drive the stock down.
I well remember CEO Itescu stating in the ASX announcements that "
a potency assay in existence at the time" had been modified. I thought the language very labored and considered. I thought to myself "why doesn't MSB just come out and say 'the TNFR1 assay' ". Well, we know now that it was because it
wasn't the TNFR1 assay , or at least wasn't only that assay.
Even as late as Q2 2022, MSB was deliberately notifying the market in terms that "
The improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes...".
But was he talking about one assay or more? And how could there be more than TNFR1-based assays? Well, of course it was an assay matrix that included IL-2 Reg alpha testing - and FDA (Steve Bauer) conceded the propriety of the MSB matrix approach even before they walked out the door ar ODAC. But we were all still focussed on TNFR1.
To me MSB's statement above i.e. even in 2020 - during the ODAC presentations & discussion - that even then MSB saw a process of validation of
the other existing potency assay as a way to address OTAT's 'concerns' was somethign like an invisible elephant in the room. .
So, for 2 years now, it appears to me that MSB has been quietly, collaboratively with the FDA and, most importantly, confidentially and trade secretly going about its business of:
A. Selecting additional reference materials for the release assay for all existing remestemcel-l stock.
B. Optimising the IL-2 Reg alpha portion (at least) of the potency assay matrix.
C. Validating the IL-2 Reg alpha assay against the clinical results back to and including the EAP275 datapoints, and then
D. Retesting all of the existing remestemcel-l stock.
I may have oversimplified the processes greatly. If so, I apologise to all MSB holders.
And there will be those who try to tear down this achievement. But I feel MSB has played this hand very well & it seems it has put the last 2 years to very good use.
Cheers all.
(20min delay)