NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

The FDA does not babysit trials. They do not decide if a sponsor should halt a trial early for futility or efficacy (though they can be asked for advice on the latter) - exwannabe

It seems that is most often the case.

http://www.cancerletter.com/articles/20151204_1

But how do you explain this...

On March 4, FDA announced approval of the Bristol-Myers Squibb drug Opdivo (nivolumab) in metastatic squamous non-small cell lung cancer. The action was almost certainly unprecedented, because the agency received the data and sprung into action—read this carefully—before the results were unblinded to the sponsor.

“With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded,” Pazdur said matter-of-factly to The Cancer Letter (The Cancer Letter, June 2). “Patients and physicians need to be informed about these findings and this was the impetus for the rapid inclusion of the survival data in product labeling.”- The Cancer Letter December 4, 2015

http://www.cancerletter.com/articles/20151204_1
http://www.cancerletter.com/articles/20150306_2