Replies to post #197444 on NorthWest Biotherapeutics Inc (NWBO)

[TopelRoad]

Marnix B 2018 ASCO (posted from Senti):

"The timing to unblind the trial… you saw all those patients that are still alive… we have to wait to see how they do before we unblind. So that’s my final conclusion here. That the timing to unblind the trial will be dependent upon the rate of accumulation of events. If patients continue to live, the temptation to unblind is great, and the pressure to do it is huge. But it could be a terrible mistake. So we’re going to be very, very careful and deliberate in making that decision."


NWBO spoke about extended survival after patients cross a 36 month threshold, but that may not translate to trial completion. Data collection may continue until a rate of events is reached. I certainly hope ~36 months triggers some sort of data review. GLTA

[Rkmatters]

They did state they would wait until the end of the trial just not in that press release. You just decide to focus on releases where they speak about possibly ending sooner. Only they don’t remind you of their own words that they plan to do the statistical analysis at the end of the trial — which isn’t the same as minimum threshold crossing. But they wouldn’t of had to because hey, they told us in August 2014 that they would remain blinded until the very end. And yes, I also believe they were subtle when they reminded us they needed a minimum of OS threshold crossing, along with ALL the treatment data clinically checked — which would be to complete at at the end. :)

[flipper44]

Here, let's make it a bit more clear the apparent games NWBO played -- if RK is correct.

August 2014 -- The Company said primary endpoint will be reached at 248 PFS events in order to determine if the primary endpoint is reached. This is normally how trials work. Evaluate later confirmed IAs were suppose to occur as well. (However, RK states because NWBO stated the company will be blinded until the trial is "completed," they really meant this trial was going out to more like the end of 2018, because she akins completed with last patient last visit. Can you imagine if people thought that in August 2014 this trial would not be unblinded until the end of 2018 or the beginning of 2019? RK states she figured this out around November 2017)

December 2014, LP actually stated they planned to reach "Topline" by early 2016 and "Finish" the trial about then. If you are paying attention, this would completely mean RK's August 2014 theory was nullified at this point. (No problem says RK, NWBO had an adaptive trial, so they can say they'll end the trial whenever they want. the "end" is suddenly whenever they say it is, under her theory)

February 2017 (skipping many other pertinent events for now), NWBO states they will reach data lock when they get to 233 OS events and reviewed the patients treatment data and follow ups. They said they were going to sites and doing this. This would normally mean all data "frozen" at 233 OS events. (Not true, says RK, what they really meant, contrary to their August 2014 sentiment, is that even though they'd reach 233 OS events by around July 2017, they were not planning on data lock until after last patient last visit which would occur by November 2018 + time to quality check those last patients. Let me run this by you again. Before they reached 233 events, they knew, according to RK, they would not actually data lock until after November 2018 -- one and-a-half years later. Somehow RK tries to argue they've been consistent about this point (she perceives) since August 2014, even though they clearly diverted from it December 2014. (and other points) )

Where I come from, if RK is correct, we'd consider NWBO misleading.


Things to remember.

Blinding is not the same thing as not knowing stat. sig. results. If NWBO knew they were statistically significant all that time (aka: end of 2015 to now), one might question their accumulation of shares over that period of time people were ill informed -- if RK is correct.