Replies to post #706392 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

If individual patient-level data was a absolute FDA requirement for ECA then no lethal cancer drug trial could be run ever again.

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. Kind of ridiculous for you to say something that is normal is impossible.

Why are you convinced LL is an idiot when she bemoans this issue and wishes there was a way to make data more available?

Also in the treatment arm every patient must be 100% identical

That is not what individual patient level data means. And not what "matched" means. Just because you do not understand the basic language here does not mean the FDA does not.

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

[exwannabe]

Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid

The FDA guidance on this reads easy,

Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations,

Your argument that this makes no sense because it makes trials impossible is absurd as trials are being run with these constrains.