EMA - very good guidance for Invex -> Proceed as planned
FDA - @curis, yes somewhat open I agree, but still positive. They want more information. They have said 2 well controlled trials would be sufficient. So there is a path forward, with options to Invex - perhaps a small delay to evaluate and some more cash burn inevitable.
So a good announcement I think. Incidentally if they burn a few mill I could not care. Big Market
DYOR
Ann: Initial FDA and EMA Advice on Presendin Development, page-6
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