Replies to post #421779 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Exactly what I thought too Hspooner.

[Basin Street Blues]

Youll remember LP said ` the halt might not have been for bad reasons ` ... but a halts a halt and no one cared ...

[Smokey21]

Yes, I believe you are 99% correct. That is the most logical explanation to what has occurred. The only thing that isn't addressed by this theory is why they assigned the last cohort already enrolled entirely into the treatment arm.

[MI Dendream]

She was referring to the halt overall IMO. Can’t be due to pseudoprogression because patients continued to be enrolled for the next three months and all were placed on active therapy, none on placebo. The trial was never halted. New screening was halted when enough patients were screened and could be added to complete enrollment in the treatment arm.

If there were any question as to the safety of DCVax, there is no way FDA would allow new patients to go on active treatment until that was sorted out. If there was still a question of efficacy, placebo would have been retained. If it were a question of manufacturing and/or storage, no patient new or existing would have received active drug until the manufacturing issues were sorted out which would have taken months to years.

There is only one plausible answer to a screening halt that continues enrollment with all new patients being placed on active drug….oh yeah, and keeping an EAP open in case the company chose to make drug available outside of a trial.

EAP is short for EARLY ACCESS Plan.

[MI Dendream]

Pseudoprogression may be the answer as to why NWBO needed to provide additional information after the decision to continue was made. It answers the question of why you would continue the treatment regimen even after the primary endpoint at the time was reached in an individual patient. Had they stopped treatment in those patients, then you would have a classic crossover design trial, but they didn’t because that would be unethical to do to those patients.

If there are fingers to be pointed as to why this has taken so dang long, those fingers should probably be pointed at FDA. I am certain LP spoke with FDA when they chose to go past 248 progressions, 233 deaths, before they published in JTM, and before taking almost two years to lock the database. They could have verbally given guarantees but obviously they did not.

[biosectinvestor]

A few other people believe that and I think that was highly discussed at the time. I do not think that is the case because 1) it was a partial halt and there is no indication it involved halting giving DCVax, but there are many fewer placebo patients; 2) that would have suggested at the time it was a potential safety issue if the actually halted for that reason, that would have required conspicuous notice and updates to consent; 3) patients appear to have continued new enrollments, but those patients appear not to have been placebo patients; 4) the company would have necessarily been fully approved or the situation and failure to disclose that exact reason, FOR THE PARTIAL HALT, would cause serious issues for them from a disclosure perspective; 5) the company has repeatedly said, including I believe during that time that the partial halt was not a safety issue and that DCVax’ side-effects and safety issues are negligible, I am paraphrasing; 6) if it was pseudoprogression why would it be a “partial halt”, again, if they suspected the drug was accelerating progression, there would be a full halt to enrolling patients and then once it was understood, the halt is conspicuously lifted, for the stated reason that caused being resolved, and that would not be because no further patients are being enrolled in my opinion, years after new patients were effectively started on the drug.

I just don’t believe the facts line up on the pseudoprogression narrative, at numerous levels and there are too many legal duties and problems that would have been created and caused a more conspicuous resolution of that problem that would have ensured it was not an ongoing issue.

Could they have continued to be blind and why would placebo arm patients been stopped from enrolling? There are too many levels at which that narrative simply, in my opinion, could not possibly be the answer.