NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The endpoints are defined in the trial protocol within the IND. The SAP clarifies details of statistical analysis.

The protocol is a formal document. There is no "maybe" in it. The trial investigators have a signed off copy that they are legaly bound to comply with. When submitted as an update to the IND, it becomes formally active in 30 days unless the FDA says no.

The "buy in" is a different issue. When the FDA allows an endpoint change, that does not say the new endpoints would be suitable for approval. It just means the new protocol (and trial IND) is still ethical to run. But, the FDA will provide a non-binding opinion on the suitability of the change in a P3. It is this opinion that is "buy in".

Every trial (at least those w/o a SPA) is the same. They have endpoints defined in the protocol that are published in the clinical trial registries. When updated, they are generally updated on the site. There is no BS about not doing so because of some "buy-in" garbage.

NWBO stopped updating clinicaltrials.gov for this trial over 4 years ago. They have not updated the status, expected number of patients or estimated primary/final completion. NWBO has a reason for not doing so, and it is not any "abundance of caution".