RE:RE:RE:RE:RE:RE:Recent study I meant to add, it all depends on how good the drug is performing, but maybe they don't need to wait until 10 if the responders show up. So the next update could be PoC but I'm not in anyway suggesting they can force it through for the next quarterly. It will come when it comes, hopefully sooner rather than later.
qwerty22 wrote:
https://www.biocurate.com/resources/proof-of-concept-industrys-perspective/
Looks like a good description of proof of concept. As this says it can be a moving target and context matters. If you took this 'practical' definition from early in that article rather than some of the scientific driven definitions then my guess is PoC comes when they hit the first go/no-go decision point.
"For industry, POC almost always applies to clinical trials. POC studies are usually small and designed so as to provide early statistical evidence allowing drug developers to make the decision whether or not to proceed into larger, more expensive Phase 2b or 3 clinical trials."
It does say statistical evidence and at 10 patients the stats will be pretty thin but I think it's plausible. So I've been saying 2 responder from 10, don't take that as gospel, but if that triggers expansion in one particular cancer and is ok'd by the fda then that seems as good a time to call it as any.
As that article points out later you can work based on more scientific PoCs, such as the one Jfm is pointing to now. Seems like a hard ask to me until you have more patients.
To be fair Paul called the 3 patients they highlighted "signs of efficacy". That's a pit stop on the road to PoC for sure.
Bucknelly21 wrote: While i always appreciate jfms posts he also say we basically had proof concept without them actually saying it and bow it seems hes saying we need to have data showing the link between the results and sortilan