Ann: Coviu and ResApp Complete Initial ResAppDx-EU Integration, page-68

If that's the case, they should have given the reason 1) or 2) and not based on 3), I think the market has misinterpret why the FDA decline (it wasn't due to safety or efficacy and RAP need to provide more data, I think these were cleared and it's point 3) and why the review took 4 months more than usual) and smashed the pps similarly to when the market didn't know how to interpret the US clinical trials results......which I've been having a very good discussion with @Petrj