For your time line reg.
Part transcript of Silviu at ********* in 7th march 2024.
https://www.youtube.com/watch?v=HBGR6ZAQPPA
(excerpt 1 original link provided hear Silviu for yourself)
[1.40] {slide InvestmentHighlights}
Wehave two platforms. One is called remestemceland the second is called rexlemestrocelwhich is the next generation using monoclonal antibodies to isolatevery very pure populations of cells. The remestemcel platform is themore advanced. It’s completed certain phase III trials and its inphase III in addition for the adult version of steroid refractoryacute graft versus host disease. But the pediatric program hascompleted phase III. Aaah it demonstrated in a devastating disease(2.18) after bone marrow transplantation that we met the primaryendpoint and we see a more than four year long term survival benefitwhere we see at least 50 percent of the children are cured of thisdevastating disease whereas very few children are alive more than twoyears using existing standard of care. (2.38). Umm. We have met withthe FDA several times and we’ve been delayed in terms of approval.We have a meeting with the FDAcoming up towards the later part of this month where we are providingto the FDA data (2.53) from a brand new, well, a newsecond potency assaythat was in placeduring the phase III but that data had prviously not been shown tothe FDA and (3.03) we’re looking forward to sharing those data withthe FDA and we’ll be updating the market after, after this upcomingmeeting. (3.10).
(excerpt 2)
(14.30) SI: I think that mightbe my last slide.
Host: Thanks. Great presentation..
There’ssome questions here. - With regard to the Ryoncil – why did the(14.42) request additional data from a second potency assay? And wasthe additional data in line with the original potency assay?
SI:Yeah. Look its the first product of its kind. First in class. Andwe’ve suffered a couple of years of delays and on going requestsfor more data by the FDA. Ah even though we were successful and eventhough we had an advisorycommittee meeting that voted nine to one (15.08) advisingthe FDA to approve the productUm,you know, FDAwants
abit more clarity and a bit more certaintythat every vial that will go into the market to treat children andadults is identical andmeets(15.25) stringent potencyrequirements. Sothis second potency assay, I think, addresses FDA’s concerns, andis yet very much in line with the first assay, and in fact(15.34) was ah, in place, even in the phase III trial. Sowe more than one assay in place, we just, um,(shrugs shoulders),we’vejust, reanalysed the data in a, I would say more robust way, andwe;ve provided all the data to the FDA, and we think, it more thanmeets, their criteria.(15.54).
ButI think, you know, you need to appreciate that the product, even whenits approved for children, will be available for hospitals and usersfor much wider use, and I think the FDA (16.07) wants to be certainthat when they release this product on the market its widespread usewill come with potency assays and disclaimers that allow it to beused safely. Yeah. (Nods). (16.20).
Host
Moves in seat). Yeah, totally understand.
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Now Reg that Silviu on 7th March. Which is after January (so The Herald Sun and The Australian I think have flubbed the timeline with respect to January- I seem to agree with phaedrus on that part) And also after I think your posts links excerpts in which you post Matt Klinker (I beleve talking in general terms in 2023 to a broad audience not about or too MSB specifically.
Silviu ("we've just reanalysed the data in a, I would say more robust way, and we've provided all the data to the FDA, and we think, it more than meets their criteria") . 7 March 2024.
(20min delay)