Hi
@col69,
as usual, HC: MSB posters are in furious agreement, and it so reminds me of the old chestnut about academic debates. Here the stakes aren't trivial, but as holders we're (unfortunately) forced to sit on our hands - unless we want to play in the markets.
IMO the CEO and Board went out of their way at the AGM to set the full stage for 2024 (which, as you mention, correlates well with multiple uses of the funding placement & insto/ retail offers, especially when NIH is going to pick up all but "
mid-single digit millions for the Phase 3 " in the adult indication for SR-/ RR-aGVHD trial costs).
I think the big picture from November 27 bears repeating, viz:
...and
I'm not going to highlight anything, because IMO the Board thought it's all important for 2024. We can all read the dates for which progress is planned & what's 'in progress' i.e. happening now. I don't think they were picked idly. The CEO made the point:
"..
some of these milestones are obviously fairly aggressive, but we're working towards them as we always do, and there's a lot of resources that go behind this snapshot.. "
However, IMO there's still plenty of room to accommodate the tactical prioritising of actual operational activities within these 3-mth modular blocks of time.
For example, FDA are still hiring like crazy for these new CBER Offices. That means they don't have the resources yet that they want to perform their functions. So, to the extent that the now seemingly more intense (and focussed) & higher priority discussions with FDA personnel on RYONCIL can advance Rexlemestrocel-l trial preparation, it makes sense that RYONCIL go first & do the hard yards e.g. to ensure MSB's CMC processes keep learning & avoid further potency assay risks (e.g. characterization, lot to lot consistency) that conceivably might affect Rexlemestrocel-l when it gets to the same place i.e. despite FDA having seen the potency assay for Rex already in 2023.
Is MSB simply going to wait until CBER makes some formal determination on RYONCIL's readiness for BLA resubmission? I don't believe so.
Remember, there is stuff already happening now in CLBP trial prep with Rexlemestrocel-l anyway e.g. (again from the AGM) " ...we continue to have our start-up activities with investigators, trial sites and contract research organization currently in place, and we expect to be able to sign up the contract with research organization that will run the Phase III program sometime in the first quarter". So, important stuff - getting the CRO and investigator trial sites onto the same sheet of music. I'd call that a significant commitment to commencing enrolment for the CLBP trial.
And lets not forget Col, as you often mention, that MSB not only can use, but is planning to have a good partnership in this CLBP space. We can all think on CEO Itescu's one-off comment during Q&A at the AGM:
" .. suffice to say that we're in quite advanced discussions in ...back pain ...with potential partners who are well aligned in the space with us and appreciate the data and the opportunities. And I think the further interactions with the FDA progress, the more attractive those discussions. ... They're in advanced discussions that are active and ongoing. "
Sounds pretty tactical on MSB's part, to me.
Cheers
GLTAH
(20min delay)