NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

You have stretched too much but your efforts are appreciated. Agreed the stubbornly fixed number of 300 and the final data collection day of September 2015 appeared in the clinical trial site might mean something although the site is famous for its unreliability: while all other trivial has been updated regularly , why not the total enrolment number and the final data collection day if there were some changes?

As far as the most positive scenario is concerned, DMC by seeing the unexpectedly good data (unblinded)can decided to have a look (interim analysis) before full enrolment. No rules have prohibited that. And if the results confirm, it can recommend stop and the company can file AA application to FDA if the results are significant good enough (for instance, more than 6 months or more PFS advantage over standard of care compared to the target 4 months). Of course, before the filing, there must first have some consultation with FDA for direction.

If FDA not buy it, the company may just issue a release saying the temporary screen halt has been lifted as the 1st interim analysis has been conducted, and the trial will continue according to the protocol.