Good questions to ask!
Is this selection of patients not considered a meaningful result?
It is not. They were looking to recruit 30 particpants.
I couldn't find a report discussing the resuts of this and presenting their conclusions.
Yeah, the reason there is no report is that nothing can be concluded. The trial was powered to require 30 participants, so anything significantly under that is pretty meaningless. But RCE keep saying it was "complete".
Is that the reason you consider they are mislabelling this result as a Phase2 ?
Well there are no results from burns. It's a different trial, the rapid IV trial, that is being mislabelled as P2.
Regarding the Indo trial. It's not necessarily a bad thing, but why Indo? They have not articulated why not Australia, or the US, which can more easily lead to global approvals. I can't think of a single biotech that has kicked off their regulatory program in Indonesia only. I'd love for someone to give a good justifcation of why Indonesia.
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