NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

The tracking sounds very good but remember on the CC Linda said she didn't even know for certain that they were in the 150-day program! Probably she was just being cautionary. Having the site inspections scheduled is a BFD. I wonder how many sites they will inspect and how many teams they have working in parallel. I don't think they cover more than a small number of sites for spot-checking rather than an exhaustive audit. Just a wild ass guess but maybe they'll take a month to complete the inspections. Hopefully not find anything to complain about. We know that NW has made major efforts to ensure the sites are prepared. It's a matter of every site being super well organized.

When I worked at IBM we were subjected to an ISO 9002 audit because the ISO certification had become required to sell our product in the EU. It took an insane amount of preparation to ensure that every single work procedure was accurately documented and all the associated documents for every person's job were online and immediately retrievable. The audit was very thorough but went quite smoothly because everybody in our organization was very well prepared. I'm sure it's much more difficult for NW because they need for all of the participating sites to be equally prepared and it's not their own people. But medical record keeping in the hospitals is supposed to be complete and airtight anyway. However, things still have happened like operating on the wrong arm or leg. LOL even though it's not at all funny if it happened to me.