From latest investor briefing webinar. Questions at the end
Dr Itescu
"The second question you’re asking is, what is likely to happen should the results be positive, I think, of the trial? So we see that the potential approval for GVHD supports the initial label of the product, and it’s built around a very large safety database. Should the COVID-19 trial also be positive several months thereafter, for example, we would leverage the extensive safety database of remestemcel for GVHD, and be in discussions with the agency around a potential label extension for COVID-19.
If we were in that position, we then have to be prepared to substantially scale up manufacturing, which is currently have invested in and are currently investing in to be in a position next year to make sufficient quality of product to start to meet some of this – the unmet need. And really the unmet need is dependent obviously on the success or otherwise of the vaccines at the front end.
I think if there’s a successful one or more vaccines, as we all hope, there will be then really the incidence of patients getting infected or the proportion of patients progressing to requiring ventilation will become more manageable. We are planning for, obviously, a long-term therapy to patients with viral-induced ARDS.
Today, the number of patients who died from influenza related to ARDS in ICUs across the U.S. is around 60,000 to 70,000 patients a year. That’s a very large number. And if we overlay on top of that, a steady state number from COVID-19 that provides us with a substantial market opportunity, but also substantial challenge for our rapid scale-up in manufacturing, and that’s exactly what we’re working towards"
Thoughts.. They are not in a covid race , a vaccine does not affect the long term profitability of the ARDS market nor does the current flu vaccines. They are scaling up for next year to meet some of the unmet need. But viral ARDS is the long term predictable cash flow opportunity. That is their cake. They are leveraging into the ARDS market using the Covid opportunity. That then becomes icing if it hangs around. As long term investors the challenge is to think and act like our CEO and not get caught up in hype. Hang in there everyone. It's just the beginning and good luck in the "momentous" coming months.
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(20min delay)