"The timeline for Paradigm's New Drug Application(NDA) with the US FDA remains on track."
They can't make a statement like this to the ASX if in fact they know the timeline has slipped by 6 months. They open themselves up to all sorts of problems like litigation etc.
I see your point about the underlying slippages and you have mentioned this before. But what I think has happened here, is that they have worked so hard on recruitment, that they know they can make time up on this aspect. So while there may be some slippages on the underlying dose trial etc, the overall programme is on target. The delay is also going to allow (hopefully) incorporating the DMOAD aspect in final part of trial.
A good announcement imo, another box ticked.
Ann: PAR Reports Phase 3 Clinical Trial Update, page-28
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