Irrespective of the funding, the intention of this trial is to gain permanent approval. EUA is just a temporary bonus IMO.
I understand the purpose of the trial, and an EUA is only ever a temporary bonus in any case.
But I wonder if the trial would be allowed to continue if there was a benefit below outstanding efficacy but with a statistically significant decrease in all causes mortality, because that improvement fell within the needs of a COVID-19 MCM?
My question that leads on from that is what is the improvement needed over the SOC for a MCM in terms of preventing death from COVID-19. Does a new COVID-19 therapeutic MCM require the product to produce outstanding efficacy or just a statistically valid reduction in all causes mortality?
Overwhelming efficacy - the stats required, page-189
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