Replies to post #748031 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Luckily, March isn't that far away. I hope this is it this time.

[StonkMaster]

To be honest, as you mentioned, the MHRA correspondence to Muee88 reads in a whole new light if you consider that inspections, or any related issues, were recently concluded at the time of the email.

[meirluc]

Just who was doing the mumbling, what did they mumble and what
was their source?

[antihama]

Flipper, to clarify, I haven’t heard anything about the inspections except what I heard on ihub. It’s just the nature of the beast that when you look at 10-15 yr old data, the documentation practices could have been somewhat lacking at these clinical sites where documentation is secondary and the patient is primary. Having said all that, if the inspections are causing a delay, I would be a little shocked. There were successive PRs in 2020 leading up to data lock where they were tackling the data head on. For instance, a PR in June 2020 describes their diligence

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs. All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually). The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations. After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.

but maybe the delay had to do w another section of the same PR

If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

Who knows?