RE:RE:Quick update: Pfizer’s tanezumab voted down!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.