Antibe Therapeutics Inc(Pre-Merger) ATBPF

Quick update: Pfizer’s tanezumab voted down!

[endpntplay]

"Edward Cheng, professor of reconstructive surgery at the University of Minnesota, said tanezumab “does not fill” the unmet need for an effective drug for osteoarthritis and chronic arthritis pain, explaining that it’s no better than aspirin or ibuprofen, or even placebo."

https://endpts.com/fda-adcomm-lines-up-almost-unanimously-against-pfizers-osteoarthritis-drug-tanezumab/

When will pharma realize that a PH3 ready OA drug is up for grabs for the largest markets: US and Europe. Soon...?

[endpntplay]

More coverage and commentary: https://www.biospace.com/article/fda-advisory-committee-raises-objections-to-pfizer-and-eli-lilly-s-tanezumab/ “A drug like tanezumab that accelerates the joint destruction of the underlying osteoarthritis disease it is intended to treat but lacks any evidence of clinically meaningful benefit in comparison to use of a placebo or oral NSAIDs obviously should

[TriumphSpitSix]

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

[MrMugsy]

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.

[TriumphSpitSix]

This sentence in the article is clearly mistyped: "The panel overwhelmingly said the risks of taking the medication do not outweigh the therapeutic benefits." That obviously should say (take your pick): "The panel overwhelmingly said the risks of taking the medication outweigh the therapeutic benefits." OR The panel overwhelmingly said the therapeutic benefits of taking

[Marky1]

Well said End..TU...one day they'll open their eyes and wallets and come charging...Widsh Stern would be doing more on our behalf