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
Actually Rhys that's incorrect. Phase III will be required for...
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