Replies to post #790895 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Edit: I am still waiting for a superior trial design

[Gus1212]

FDA Approved the Cross over!

It's been a while, so I am going to assume you just forgot about it.

[AllSheWrote]

The takeaway is that placebo arms can often not be used in immunotherapeutic trials.

I mean, you don't have to use them. Ethics are a tricky thing. On the one hand, you can think you are being ethical by allowing crossovers, and then your drug doesn't get approved and more people die. Or, you can take take the perceived unethical route and not allow crossovers, get your drug approved, and go on to save millions of lives. It's a tricky thing, I know.

[Doc logic]

meirluc,

The Germans put an exclamation point on this ethics issue when they refused to allow SOC/placebo to be fully enrolled because treatment effect and longevity would be delayed and reduced. I mean since 2015 it’s been a big DUUUHHHH about efficacy, the problem of treatment induced pseudoprogression and the need for an adequate comparator. Since then the problems have been acceptance of comparator method, needed changes to regulatory governance and manufacturing safely at pace from a closed system approach vs open artisan method. This became a top priority after NIH experienced a contamination issue in late May 2015 with production of albumin (a protein component utilized in manufacturing L) with an open system method that they then closed and offered a process patent to NWBO for which was accepted and incorporated into all future production of L. Best wishes.