Focus
The company is focused on Remestemcel-l for Covid-19 Ards EUA with Novartis as the blockbuster.
Approval of Remestemcel-l potency assays at OTAT
allows for the resubmission of BLA for paediatric AGvHD.
Approval of Ryoncil on the paediatric market is one step -
Everything else is noise.
My guess - my noise if you like
Confirmatory Covid-19 Ards trial will commence in partnership with Novartis immediately on OTAT concurring with the FDA that the potency assays are
acceptable.
By the time - 6 months- the BLA has gone through the process it’s feasible that a trial conducted in under 65s
with elevated Crp levels will have been stopped for
overwhelming efficacy.
FDA then grants the EUA for COVID-19
Who’s is going to stop a cure?
Unmet need people .
Unmet need for Severe Ards -
Mass production is the missing link for an EUA- ahhh welcome back to the circle of life- that’s why Novartis
is waiting. Size of partnership will depend on what needs
to be invested to scale and the supply limitations will affect
market valuations.
We ain’t trying to develop a cold and flu tablet
It’s a tad more important
Rant over
Sorry
Reg
Ann: CEO Presentation to 2021 Annual General Meeting, page-51
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