Replies to post #437101 on NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Got it?

I doubt it :-d

[exwannabe]

I disagree on that wrt the FDA. The FDA would certainly have comments on such a huge change. They would allow the protocol change, but the comments are what counts.

As far as EU. The change was submitted to the countries (not the EMA), as trials are regulated at the state level. The only responsibility they had was to accept it as a safe change to the trial.

Why will NWBO not discuss this? Again, they made a big story of working on the SAP. Then radio silence right at the point where any disclosure would have to include the bad news.

[TiltMyBrain]

Overall survival is the gold standard

Way harder to achieve than progression estimates

All you have to do is count the living. Not too tough