Replies to post #394636 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

And if they don't change the endpoints, the trial fails because of pseudo progression. They should just do that, right? Throw that baby out.

[sentiment_stocks]

So you say,

The FDA would not fall for that game, but a subset of investors will

But this December 2019 FDA guidance says differently.
https://www.fda.gov/media/133660/download

[thermo]

The answers to questions of (a) the use of external controls and (b) changing of endpoints (e.g. whether data snooping occurred or not) are not black and white. But the nuances are hard to discuss on a message board (actually, everything is hard to discuss on a message board).

I’ve considered these questions and yet hold a sizable position.

[Dr Bala]

Hard to argue against the survival benefit. The last sentence is basically nonsense.

[flipper44]

I see Sentiment Stocks showed you the 2019 guidelines (See pages 14 and 15) . The trial risk is legally mitigated. Give up ex. Moreover, an endpoint in the trial still evaluates treatment arm against placebo for survival efficacy. Give up.