NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Try harder.

42 CFR 11.48 s specific to results. There is a lot more to 42 CFR 11 than just results.

Try 42 CFR 11.64 which says when the registry information must be updated for changes.

Start with (a)(ii)(A):

(A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not less than once every 12 months

Then try (a)(ii)(F)

(I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. At the time, the date is changed to “actual,” and the Enrollment data element specifying the actual number of participants enrolled must be submitted.

But the specific issue being discussed was in (a)(ii)(O):

(O) If a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board.