Replies to post #232447 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

It also rules out the futility. If there was a problem with the trial or if the FDA thought it would likely fail they could not lift the halt. This is in the statutes and is not a matter of opinion or speculation.

Right!

[iclight]

Wrong. As has been discussed before, the Cyclacel P3 trial. DSMB futility rec, no safety issue, the trial can continue.

Cylcacel Futility rec, trial continues

However, the independent data and safety monitoring board recommended that the patients remain on the treatment as the interim data analysis showed no safety concerns.

In this case, the FDA didn't need to halt enrollment because the trial was already fully enrolled.

And this will be the outcome here:

Feb 23, 2017 - Seamless study fails

The trial did not meet its primary endpoint of demonstrating statistically significant improvement in overall survival (OS) for the experimental arm versus an active control.

In December 2014, the study’s monitoring committee determined after an interim analysis that the futility boundary was crossed. In accordance with the committee’s recommendations, the Company continued to follow up enrolled patients to maturity.