Replies to post #559660 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

No, they did not say it was based on “data” from the trial and I know some want the change in endpoints to effectively not have been approved, but the were and prior to unblinding. Further the SAP was drafted by a completely blind third-party entity, working with expert doctors also not connected to the trial.

They clearly made every effort to ensure that these false arguments cannot be made.

And we have discussed other circumstances even a BP that already had a special protocol assessment (SPA) that ultimately revised their endpoints with the approval of the FDA before unblinding and despite that scrambling the SPA.

Repeating facts that are not necessarily true together with speculation that is false that it wasn’t approved or that it violated core concepts around revising SAP’s doesn’t make those related statements more true the more frequently those false details get repeated.

[Dr Bala]

Nonsensical statements after the publication in a top journal.

[dennisdave]

You really are cluless

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/

When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?

To evaluate whether a change in endpoint is independent of data from the trial, investigators and reviewers should ask three important questions. First, what is the source of the new information that elicits consideration of the change in endpoints? If the source is external to the trial in question, for example arising from results from another trial, then the revision of endpoints may be credible. Second, have interim data on the endpoint (or related data) from a trial been reviewed? If trial data have not been reviewed, then the revision of endpoints may again be credible. Third, and most importantly, who is making the decision regarding endpoint revision (e.g., trial sponsors or an independent external advisory committee)? Appropriate decision makers should have no knowledge of the endpoint (or related trial data) results. In particular, if interim analyses have been conducted, the decision makers should not have knowledge of those data

Even if NWBO had an IA, which they had not and you can not prove they had any, then still its irrelevant. As long as those making the decision to change the endpoints and how the changing of the endpoints should be handled, have no prior knowledge and are objective (Dr. Kevin Duffy the architect of the amended SAP) to any prior history of the trial (data) then thats acceptable. Thats why, as I have said here a few times before, is why Dr Bosch, as the CTO and architect of the original endpoints, moved back to Amsterdam to remove himself physically as far as he could from the changing of the endpoints.

It has absolutely NOTHING todo with Linda Powers you are completely and utterly CLUELESS

[Doc logic]

exwannabe,

In order for PFS to fail it must be proven that true PFS failed. There is an appeals process that allows proof to be given that true PFS did not fail and proof of treatment induced pseudoprogression can be presented. The fact that PFS had to be adjudicated led to them changing the endpoints entirely as there still is no perfect way to separate true progression from pseudoprogression but the fact that treatment arm patients are living longer in spite of apparent progression confirms the problem.
The issue with endpoint changes on the clinical trials site, unlike Europe where the changes are made by others than the sponsor, is the rational for doing so must be made public first or there could be legal ramifications. This led to the May 10th attack which now is being used to take down the crooks who thought they could get away with what they were doing. FDA will take no issue with what had to happen as the company was blinded and protected by firewall the entire time that changes were made and they had their own blinded data to make determinations about potential PFS problems because of pseudoprogression. They didn’t need others to tell them. Best wishes.

[kabunushi]

Further, the OS endpoint change, they flat out said it was based on data from the trial. The high crossover count was data form the trial.

Of course the overall crossover rate was not blinded because the patients had to request cross-over, and almost all did. They knew there were pseudoprogressors who had been incorrectly determined to have progressed. Some crossed over from placebo to dc-vax and some crossed over from dc-vax to placebo. IIRC even some early vaccinated patients had 'hot' dc-vax doses remaining because different numbers of doses were obtained depending on the amount of tumor tissue that was extracted on the original surgery, and they were given those doses until they ran out.

LL said years before unblinding 'everybody is living longer.' They knew who died but until the data was unblinded they never knew of those who continued to survive whether and when they had received dcvax or the placebo.
WRT the PFS endpoint being invalidated due to pseudo-progression, they knew very well from the progression of symptoms that they had a problem because the radiology wasn't correctly distinguishing who actually progressed vs who were pseudo-progressors.

Spin as much as you want. We have clear valid data that dc-vax works as well as the clinicians say it does. I will be very surprised if the RAs will insist on throwing to satisfy complaints coming from those with a financial interest in delaying dc-vax coming onto the market.