Harry,
<<But as you know, I've been wrong before when it comes to neuroprotection in stroke.>>
Me too, at least in one case (if not more). As I said early, didn't follow field for years, so my simple question to you (it is yours field), or anyone else with knowledge, is:
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?
Appears that this is AZN position, still no guaranty that FDA will accept this approach, at least without positive trend in NIHSS. SAINT I indicate no positive trend in NIHSS end-point, and pts number increase may only further neutralize any positive trend. Further, AZN is banking on drug combination with tPA (maybe the only, and best approach, imo). In that case 20% penetration is max. I do not have original NEJM article on SAINT I, it will be interesting to see what is mRS p-value for tPA pts?
To others, sorry for bringing this discussion on Valuation tread, it is (for now) RNVS specific.
Miljenko |
