NorthWest Biotherapeutics Inc (NWBO)

[iclight]

None of that addresses anything Hygro wrote.

The company ran combo trials years ago and everyone claimed they'd be partnering with Merck. Nothing happened. Early stage success happens with many trials because of selection bias. And they die when a legitimate comparator trial is run. Like the original P3, not the cherry picked bullshit non-patient level data hail mary P3 that this trainwreck has morphed into because it failed originally.

The FDAs draft guidance from this year doesn't even address ECAs without patient level data because it's a non-starter.

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance for Industry

B. Access to Data and Documents

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, for both the treatment and external control arms. If sponsors do not own the data
used for the external control arm, they should structure their agreements with the data owners to
ensure that patient-level data can be provided to FDA in support of the marketing application.