Actually Rhys that's incorrect. Phase III will be required for FDA approval, but Prima is currently undertaking Phase IIb - they started recruiting about the middle of last year - they plan on 60 patients but it's hard to find out how many are enrolled in that trial currently. Anyone know?
We are still some 2-3 years at least from phase III results. But remember that this was always going to be a 15 year process so in fact we are entering the end game now. That's why things are warming up I believe. It ain't hot yet but wait till it really gets pumping when positive IIb results (if that's the case) appear and we move to Phase III!
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I have no knowledge beyond what's publicly available, but that doesn't stop me forming strong opinions! Which is all this post is. DYOR
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