<<Can FDA give approval based on modified Ranking Score (mRS) end-point without positive result on neurological impairment score (NIHSS)? Additionally, what p-value (<0.01, I guess) will be of medical significance to neglect NIHSS score end-point failure?>>
The FDA can do whatever it chooses. But I do know that Rusty Katz told one company that if they brought him two trials both reaching .05 on the primary endpoint (which for them was a composite), he'd approve it. Would the same go for just hitting the Rankin? Given the lack of alternatives, if they hit .05 twice, I'd say yes.
<<Further, AZN is banking on drug combination with tPA (maybe the only, and best approach, imo). In that case 20% penetration is max>>
I disagree. Yes, the combo will be optimal. But the beauty of the Renovis hemorrhagic stroke trial was that it showed no worsening when NXY-059 is given in a hemorrhagic condition. Which means they don't have to wait for the scan to find out if the pt is safe for tPA, so more patients will be given the neuroprotectant than tPA. And if a pt arrives four or five hours post-stroke, if NXY-059 becomes established, it will be given anyways--at least a good proportion of the time. Which is why I expect that, if approved, the penetration rate will hit 50%.
Harry
NeuroInvestment |
