Replies to post #234256 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Agreed that the window between data cut and data lock should be very short by now (1 hour would be an exaggeration, but a few days very possible).

The real question would be what does the SAP say about the issue? Will it call for a final analysis at 4 years? 5 years? 300 OS events? 233 OS events, ....

And how long will LP play ping-pong with regulators who have questions on the SAP (even though they formally accept it)?

Nobody knows.

[Evaluate]

my comments in red.

They threw in a twist. Who threw in a twist ... NWBO? And what is the twist? Is the twist that the analysis will include data up to the HARD data lock?

Dr. Bosch states the analysis will include data up to the data lock. Perhaps what Dr Bosch means when he says this is that the analysis will include data up to the SOFT data lock (which may have occurred in Jan 2019 or so).

37:35 This means they are doing it differently. I listened to this again. After all the data has been checked and validated (including queries & case report form reconsiliations, resolving discrepancies etc) and after SAP finalized, then the database will be LOCKED (and that is when you can do the analysis). He did also add .... "for the data up to that point". I agree that this additional quote is confusing.

They must be continually checking against realtime patient data. How else could they do it? It's not that hard to log an event as you continue validating. I have the impression that what Innes is indicating is that any of the data that they accumulate after the soft data lock will not count towards whether the trial is approved or not approved, but it merely provides additional insight regarding the trial after it is unblinded.

They only record PFS and OS after the 36 month visit by phone. OK. However, if a PFS event is recorded after the 36-month visit, then I think this would still result in the need for Physician validation, Data Entry validation etc.

They've said nothing about a soft data lock. Perhaps they have not mentioned Soft Data Lock in their public statements. However, I think it is the only way that trial data is accumulated and then verified prior to Hard Data Lock. I think it is "presumed to be the case" in NWBO statements, including Dr Bosch presentation.

On the other hand, Dr. Bosch's comment that data up to data lock is included is clear. Not really. I think what he "means" is that data up to Soft Data Lock is included, and then it must go through the verification and audit process etc, and once that has been fully completed, then this verified data through Soft Lock then is Hard Locked.

If everyone was home, ten people could validate OS that in one hour. No, because each event, even an OS event would cause the need for further validation (beyond just a phone call).