NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

A cautionary thought relating to my previous optimism as to the
imminence of approval is embedded in this just released 10Q
because it seems that additional MHRA inspections are still
pending and have not yet been scheduled. Also apparently
in preparation for those inspections, the company is arranging
for additional mock inspections.

If you find that I have misinterpreted this 10Q section please
let me know. I. really hope that my concerns are unfounded
and that the upcoming ASM will not precede the long awaited for
approval.

quote]: for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.