NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

There were more than 6 versions of the DCVax-L trial protocol... each version was an update from the last one. I have at least 4 of them... with two being made public by UCLA, and two having been accidentally leaked. There were significant changes made between them, such as the pseudo progression arm having been dropped.

The final protocol was completed before the trial was data locked and unblinded. Along with the Statistical Analysis Plan (SAP).

And with each change, there was a complete and very thorough explanation made to the regulators. One that took a long time each time a change was made to hash out. Many of us went through the Jan to August 2014 change... so there's that. Prior to that was the one that covered the change from a P2 trial to a P3. That change was also completely hashed out with the regulators.