NorthWest Biotherapeutics Inc (NWBO)

[Ready4bluesky]

More recently in October she indicated the current estimate for reaching the primary end point is September/October 2016.

The following is a list of events I've pieced together (mostly from your posts) that may be part of what we will call a likely scenario (among several). Please review when you have time and let me know if I missed anything.

The 1st IA occurred around June/July 2015. The results were statistically significant enough to warrant a DMC recommendation for regulatory review, but it was necessary to wait until the number of patients enrolled/screened reached a number where full trial enrollment was 'reasonably expected' to be attainable from the pipeline.

The enrollment/screening requirement occurred in early August and the screening suspension was implemented.

The regulatory information (AA/BLA application) was filed in mid September.

Full trial enrollment may have been reached at the end of October (as indicated on the .gov status change). They have not announced it due to the close proximity of the 1st IA and regulatory filing and the conclusions that could be drawn if everything were PR'd. Or, enrollment has not been officially completed, but the last patient will begin first treatment in the next few weeks.

They are currently working with regulatory agencies through rolling review, and are awaiting a 74 day response that may occur any time between now and the end of February.