NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

"out of box' thinking? He is not close to that or he is much more than that dependent on convenience.

For instance, in his post citing impossibility for interim analysis to be conducted if enrolment is not complete, the document he cited is an FDA discussion I remembered clearly in the time when I have involved in a couple of Non Small Cell Lung Cancer companies as an investor, and is titled "Clinical Trial Endpoints for the Approval of Non Small
Cell Lung Cancer Drugs and Biologics Guidance for Industry."

1) Clearly it is specific to Non Small Cell Lung Cancer companies [it may not apply to other cancers, although it might have reference value]; and
2) It emphasizes "the observed magnitude of effect should be substantial and statistically robust," and " In addition, a statistically significant difference in PFS that is small in magnitude may not be deemed clinically meaningful." [the small here means 1~2 months PFS with significant p].

So a company which uses PFS as primary endpoint for Non Small Cell Lung Cancer indication can definitely have interim analysis before full enrolment and DMC can definitely recommend trial be stopped due to efficacy as long as PFS advantage is significant [like 3~ 4 months or more] with significant p value and the treatment is of course safe.

For those who are interested, the link of the document is below:

http://www.fda.gov/downloads/Drugs/.../Guidances/UCM259421.pdf