GREY:ATBPF - Post by User
Comment by
MrMugsyon Mar 26, 2021 10:05am
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Post# 32885450
RE:RE:RE:Quick update: Pfizer’s tanezumab voted down!
RE:RE:RE:Quick update: Pfizer’s tanezumab voted down!TriumphSpitSix wrote: This gives us good goal posts to aim for.
Our Ph.3 needs to provide "convincing evidence of a superior efficacy" of OTEN over NSAIDs (easy) and any dose-related adverse events need to plateau (or better, trail off) by the end of the study. (Harder since we only have safety data out to 2-3 weeks tops and Ph. 3 is 12 weeks of dosing.)
This supports my prior suggestion that Antibe could reduce the dosage down into the sub-100mg level and still demonstrate superiority to NSAIDS (Naproxen specifically) and more importantly, significantly reduce the possibility of adverse GI or hepatic effects over the much longer Ph. 3 dosing period than we currently have data for.
Better safe (and still obviously better than other NSAIDS) than sorry.
Triumph ... superiority in safety (that's the key).
On the efficacy side (pain and inflammation) - we are not aiming for superiority - want to be "as good" as the other alternatives, with less NSAID (active ingredient).
I think we mean the same - just wanted to clarify.