NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

wrong

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

In general, that is correct and I agree that NWBO has clearly not adhered to this NIH rule and made a long nose towards this rule since 2016 by not updating their trial government website page. No NWBO long will disagree with that, but that's not the subject now is it. The subject is, is NWBO amended to disclose it has changed its SAP. So you changing the subject now is what I have seen you do many times before as you do in your next point

(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.

what has the NIH rule requiring NWBO to submit trial results one year after primary collection date as described and specified under § 11.42, clinical trial results information 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, to do with the point at the discussion which is the yes or no requirement to disclose the amended SAP? For the record yes NWBO has clearly violated that rule by a few months now but that discussion has been held here long and short and is AGAIN another subject.


Then this

(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.

But the DCVAX L protocol has not been amended in such a manner that changes are communicated to human subjects in the clinical trial now have they ex?

Try harder ex