Replies to post #514583 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

NWBO was asked long before about updating the clinical trials site and they discounted it as just a clerical issue. I never bought that.

So, to clarify, NWBO misled shareholders on this issue.

That’s an issue, though how serious is open to debate.

One can justify management misleading stakeholders out of necessity but this information shows that when there is criticism that NWBO management has not been honest, there is truth to that as stipulated by both both pro and anti mananagenent shareholders.

Then the only remaining debate is the degree to which this behavior exists and the extent to which it exists.

[Hopeforthefuture3]

Doc L, I questioned DI in late 2020 as to why we saw the new evaluation protocol (SAP) on the European sites and yet clinicaltrials.gov did not and just got total evasion from my questions- only thing DI would answer is that the cl.pany was responsible to update clinicaltrials.gov
I still find it very difficult to believe there are legal ramifications for having the actual evaluation protocol (SAP) listed on the usa site as well as Europe- and they are still different as clinicaltrials.gov last I looked shows a singles secondary endpoint to evaluate while 5 are shown for Europe
I do believe that ultimately once a bla is submitted that it is up to FDA to decide if the SAP is valid to evaluate a product for approval but I do not think it involves legal liability
Bty do you know how large/difficult a process it is to write and submit a BLA? Are we talking weeks, months, year(s) - I do not know and am very much wondering how big a project this is - might it take a similar amount of time as for the SAP?