@Zenox@stockrockHi again guys,
I intended to include this as a reply to
@stockrock (Post
#:61149168) and
@Zenox (
Post #:61157419) but there was a problem with HC.
Actually, just on that last point about the CQA validation data, there's been so much confusion on HC:MSB previously, I'm not surprised it's still around.
Many non-holders have suggested new potency assays may not even have have been theoretically designed or created - much less run through validation on cryogencially stored stock. I'm no manufactuere, but I accept t's not a simple task - after all, one has to create a matrix of assays that quantitatively measure the relevant biologic functions that align with the scientific rationale for treatment. IMO it's worth keeping in mind exactly what CEO Itescu said in October 2021 as part of an exclusive interview to the Wall St Transcript on these new assays i.e.:
" .
We’ve continued to make the product. And we have established new assays that I think continue to even further underline that we understand the mechanism of action and that go to the heart of the mechanism that the cells go through in order to improve the outcomes in these steroid-refractory GVHD patientsAnd so we think that we will have alignment with the FDA because the potency assays now are very much in line with the disease process, how we think the cells turn off the disease process. And we think that it’ll allow us to be very confident, and for the agency to be confident, that as the product is hopefully in the marketplace, it will demonstrate that every lot behaves exactly the same way as the lot before.That’s really what the FDA wants. They want to see that we’ve got a handle on the mechanism, that we have a handle on the production, that there’s no differences in production from every product that goes out the door. " (interview link
here )
The language used by CEO Itescu in the interview is a lot less dry than MSB's 31 December 2021 announcement (link
here), which I suspect wasn't drafted as a press release.
But read the two together i.e. the interview and the announcement & you'll soon realise just exactly how significant these additional assays are likely to be for remestemcel-l's future & the future of MSB for that matter.
Clearly, MSB will not be showing the world those potency assays &, subject only to acceptance as validated by CBER/ OTAT on the resubmission, they will IMO effectively 'broaden' the IP moat for MSB which will in turn provide even more durable benefit to MSB shareholders from any resulting approval(s) and any supplemental approval or label extensions over time.
I'll get back to you all on those other points in Post #: 61163205.
Have a great day.
(20min delay)