Replies to post #774381 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

AI, Are you saying that all those years of Les’ Big Biz Show appearances were purposely meant to look like a joke?

[exwannabe]

The Pediatric Investigation Plan was approved in 2022 using the same matched external control methodology as the adult trial.

That argument is very flawed.

First, the pediatric studies are early stage, not pivotal. Nobody cares if the endpoint is established, it just needs to be sufficient to run later stage trials. Many such trials have similar OS comps.

Second, he fact that it is prespecified is a huge factor. Read the MHRA guidance and see how often they talk about pre-specified. And they define that as prior to enrollment. IMO , that is a bigger problem with the -L trial analysis than lack of patient level data..

Third, though it uses an ECA, it is not the exact same SAP. That is obvious. That LP hypes it as the same is just playing to her suckers.

But whatever. LP played a brilliant card wasting time on submitting a PIP that is never going to be used. Plenty of free hype.

[exwannabe]

What’s likely happening is not a delay. It’s a controlled alignment. SI 87 changed the law in the UK. Flaskworks reached automation readiness

Uhm, really?

First, we know that NWBO is waiting on the C cleanrooms before they even have the EDENs designed to be GMP client delivered and start testing, So they are not even close.

Second, what that law does is allow additional MFG sites to be approved under the "parent" license. NWBO has spend 2 decade and well over 100M building LP's 2 CDMOs. The idea others will just spout up is kind of hard to make work.

The idea that the MAA is being held up for EDEN is, and always has been, total quackery.

[sentiment_stocks]

Powers has kept it moving through walls.

That is so true, IMO. :)