Replies to post #706397 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

The term individual patient (or participant) data (IPD) is defined as the information obtained for each specific patient in a given study. It is the most detailed level of information on the individual patient available. Individual patient data would consist of a specific patient's demographic characteristics (e.g., age, weight, and gender), both assigned treatment and actually taken treatment if those data are available (e.g., drug used, specific dose, and dosing schedule), disease characteristics (e.g., disease stage and baseline biomarker) and the individual drug exposure measurements (e.g., longitudinal concentration over time data points, maximum concentration [C max], and area under the concentration time curve [AUC]).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10508576/#:~:text=The%20term%20individual%20patient%20(or,on%20the%20individual%20patient%20available.

[dennisdave]

That is not what individual patient level data means.

no Im saying that is what YOU think what it means. which is idiotic. If you don't think that that is what it means then we agree and general/average/medium etc patient data can be used for ECA as well.
Its you who don't understand what individual patient data means and why its not necessary for ECA comparison.

Why are you convinced LL is an idiot when she bemoans

I was referring to the shorts and bears as the idiots

Looks to me like plenty of cancer trials are being run and we have yet to see one with an approval based on summary level ECA data.

Provide me with a current lethal cancer medical trial where the sponsors have no problem letting the placebo group parish to be able to compare the data to the treatment arm. I know you are medieval and have no ethics but that is not how we do things anymore in 2024.

If it is so obvious that the concept makes no sense, then why did the FDA put it in their ECA guidance?,

If obvious then why dont you quote the FDA on this issue? Why are you refusing to do so for months now? Perhaps you dont understand FDA language is that it. Too difficult for you? Pock pock pock pock