GREY:ATBPF - Post by User
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TriumphSpitSixon Nov 30, 2020 1:02am
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Post# 31998496
RE:RE:RE:RE:RE:Pfizer's anticipated approval of Tanezumab for OA
RE:RE:RE:RE:RE:Pfizer's anticipated approval of Tanezumab for OA100mg is still my target. The safety profile at this level would be unparalleled and if efficacy is even 75-80% of the "unpowered" 150mg dose it would still work well AND be an absolute rubber stamp for FDA approval.
The unpowered-for-statistical-significance 150mg dose demonstrated a WOMAC score (39% reported pain reduction) that was only 5% lower than either the 200mg or the 250mg which both demonstrated a 44% reduction at 14 days. We know from anecdotal evidence in other NSAID trials that pain reduction continues to increase out to what, 6-8 weeks, so this number will continue to rise.
Safety is No. 1 for FDA approval. Cut efficacy a few percent to guarantee safety = WIN.
MrMugsy wrote: Correction on dosing ....
If we can prove out 150 mg ... that's 1/6.67 the naproxen (we have a chance).
If we can get to 125 mg ... 1/8 the naproxen (I will cross my fingers and bet on this one ... for fun!).
If we can get to 100 mg ... 1/10 the naproxen (I would not take this bet ... even I don't believe it and I've been extremely positive to this point).
: )