Replies to post #562013 on NorthWest Biotherapeutics Inc (NWBO)

[hope4patients]

You’re clearly wrong on multiple levels.

[sentiment_stocks]

Could you please cite your source for this quote? I can't find it (using command F) in either journal article (JAMA and TJM) nor in the JAMA supplements. I'd like to see the full context, if possible.

The vaccine was aliquoted in individual doses and cryopreserved at < 50 °C [22]. The doses were stored centrally, and shipped individually to the clinical trial sites.

[sentiment_stocks]

I believe that the doses being shipping to the hospitals was kept blinded, meaning the central location that was shipping the doses could not know or see the patient name and/or number as it was hidden to all but a single or very few people at the CRO. This or these few people would have had a special dispensation to direct the blinded lot number doses to their respective medical centers.

This article offers an example of how carefully the blinds in these clinical trials are maintained.
https://eclipsesol.com/2016/02/22/maintaining-the-blind

But who really cares about the merits of what I consider to be your false and ludicrous claim of that Linda somehow snuck in to Cognate and peeked at the blinded data without leaving some sort of data record trail of such an action.

What’s important is that we can see from the data thus far presented is that DCVax improves the survival rate by more than double when compared to the percentage of GBM survivors from what is now a very large number (1366) control patients (our randomized control arm was just 99) with an amazing hazard ratio of .80 and a 98% confidence interval.

In other words, 20% of the ndGBM population are less likely to die when receiving DCVax-L compared to those patients who don’t receive DCVax-L, and the certainty of this is just 2% less than 100%.

And for methylated treatment arm patients, their hazard ratio was 0.74, so they were 26% less likely to die when receiving DCVax-L than when compared to their methylated counterparts in the control arm; again, that is with a 98% CI.

And for the rGBM treatment patients, with an HR of 0.58 and again a CI of 98%) - whew! well with a 42% less chance of dying when receiving DCVax-L in recurrent GBM, we should be over the moon!

No wonder the clinicians are excited.

The DCVax-L data and results for both newly diagnosed and recurrent GBM are both solidly impressive figures, and while you apparently choose not to recognize this, what’s important is that the regulators recognize it.

And to circle back to your empty claim that LP broke into the blinded data record to look at the blinded shipping records, it’s unfortunately just a waste of time to argue it because you will never concede or agree to any points that I might make regarding this, because your claim fits into the "post-hoc" narrative that Adam and the other naysayers are spinning. I’d be very surprised that if there were ever an FDA AdCom meeting to discuss whether DCVax-L should be approved or not, this post hoc argument claiming the decision to use and assemble an ECA arm instead of the original randomized control arm was made because the CEO of the company had earlier looked at the blinded shipping records and knew from such a peek that the original endpoint comparing progression had failed will never see the light day at such a meeting. It’s silly, and IMO, and anyone understanding how a trial blinding is protected should be embarrassed to make it. It's simply grasping at straws.