This slide is interesting. Even if Mesoblast get downvoted by ODAC tonight for efficacy, but get positive results from the secondary outcomes in the COVID-19 trial i.e. shows a reduction in pro-inflammatory cytokines e.g. TNF-a etc (whether the COVID-19 trial suceeds or not), then they provide evidence towards showing the mechanism of action and therefore can satisfy the requirement for potency irregardless.
So we have two potential ways to prove potency: 1) by providing efficacy, which might be enhanced by a favourable vote at tonights meeting and 2) a reduction in pro-inflammatory cytokines in the COVID-19 trial regardless of whether it successfully treats ARDs or not
Disclaimer: these are my views only, DYOR
This slide is interesting. Even if Mesoblast get downvoted by...
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