NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Ok then Im going to be as clear as possible too for we do not understand each other

Its common basic knowledge that the sponsor handles his government trial websitepage. Its also commonly known that the EMA, after being updated with trial protocol and endpoints by an EU member, handles the EMA website and not the medical sponsor.

In my view, you have not addressed the points which I posted before:
1. It's highly unusual, at least I have never heard of it perhaps you?, that a biotech company does add its endpoints to its page on clinicaltrials.gov, but does NOT have a plan in place that describes the planned analysis of the clinical trial they are conducting (aka the SAP).

Thus in other words NWBO did NOT have an SAP in place but did communicate endpoints. Again unusual since the study is open-label right

the statistical analysis plan should be finalised before the unblinding of study data, or in the case of an open-label study, before the conduct of the study.

http://onbiostatistics.blogspot.com/2020/01/pre-specification-and-statistical.html

2. I have already posted before that a biotech is NOT required to submit a SAP before the trial is unblinded https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167437009
Under § 11.44 d.3 the following is determined.

“(3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan”

3.

I'm not exactly clear what you're asking...

Im not asking you anything. Im just saying that I find it remarkable that NWBO did NOT have a SAP in place but did know its endpoints as far back as 2016 is all.

Thats why I said "Yes I know you cant do an IA without an SAP, but perhaps you should chance that you cant do any without one officially being submitted with the FDA." But now it turns out they did not have any from the start.