There has been much discussion and unmeasurable noise about achieving statistical significance vs SOC. But isn't it also possible that achieving marginal improvement over SOC with vastly less side effects could win approval, especially in palliative terminal management? Or is the game strictly black&white: statsig or fegggedabowwwdit?
"But isn't it also possible that achieving marginal improvement over SOC with vastly less side effects could win approval, especially in palliative terminal management"
Yes. Alimta does not have and increase in OS over the comparators it was trialed against but it has a far better safety profile. This not only made it approvable but it has driven its commercial success.
You bring up a good point that I haven't seen discussed here. They could go head to head with the SOC in several indication with REO in combination with low dose paclitaxel and not even have OS improvement as an endpoint. They could get probably get this approved if the OSes for both arms were statistically equivalent but the grade 1/2 toxicities seen for chemo were missing on the REO arm.
I would be extremely happy if the H&N trial achieved statsig (if one assumes that .05 is statsig, and there's plenty of room for debate about what statsig is from what I've read). Personally, I don't see it reaching that good of a level as most of what I've seen/heard/read says it's highly unlikely to achieve such a positive result with a small enrollment like we have here. Maybe in one of the subgroups (mets only perhaps), but not for the entire trial population. But there's much to be happy about if we come in at .1 to .2. Those aren't bad numbers, although I'm fairly sure the market would treat them as bad.
This topic is sure to stir up emotion, D2. What are your thoughts?
My guess is the market will react badly (How badly I don't know) if its less than stat sig, but the news will be less bad (or as you suggest even good) in terms of longer term approval. It might be a very great buying opportunity.