banter and General Discussion, page-8266

Hi @irenekwshiu

IMO MSB isn't waiting for anything. I expect it's driving it. As I see it, the study elements are in process now, and would have to have been for some time.

I'm not sure exactly what you're referring to re 'early October', but IMO these study/ies, or at least the prep for them, commenced prior to August 31 Operational Update, & were referenced by CEO Itescu in passing when he said:

" ..measured using the potency assays that are now in place and that have in part been shown to the FDA, although there's additional potency assay work that we're now undergoing that we intend to show further to the FDA... " and again

" ..And our potency assay needs to be substantially the same potency assay as was used in the Phase 3 trial in order to demonstrate that the 2 products are the same. And we have those data that are currently being developed. Some are in place, some still need to be added. We expect that in the next few months, we will complete those data. And that is part of the discussion with the upcoming Type A meeting. Perhaps Phil Krause could add some color to my comments... "

So, the 'next few months' is not a tight timeline for any studies, as I see it.

But to meet the timeline announced by CEO Itescu during the AGM webcast on November 27, any studies would need to be concluded in time for analysis, results write up, data formatting to FDA requirements (maybe) & for packaging in required format (along with other stuff to do with the adult trial) in time for a Type A meeting to be held within Q1. His exact words:

" ....And so that's a parallel strategy for us as to how we go back and present them with additional potency assay data from -- explicitly from product used in the Phase III trial ... And I think that discussion still has to be had in the first quarter as to the totality of that data. "

So, I think things are moving apace right now.

All good as I see it.
Cheers