Replies to post #234263 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Evaluate said:

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?

NWBO did. They stated the data will be included up to data lock.

Evaluate said:

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.

It's not confusing. It's clear. It just doesn't fit your paradigm. You have the same paradigm I had before Dr. Bosch spoke at ASCO. He changed the narrative.

Evaluate said:

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.

I don't have any confidence in the phone, "impressions" and Innes. Again, Innes is saying what I thought before Dr. Bosch spoke at ASCO. However, it's not what Dr. Bosch said at ASCO. Innes is there for himself and the investors he had brought into this, imo. He needs to make official written or recorded statements that he has received accurate answers for from the source, and quit using the phone. Otherwise I assume he just guesses. These are material matters he is supposedly contradicting Dr. Bosch on.

Evaluate said: 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.

Nope, instead, he clearly said, "the database will be locked for data up to that point." You are making things up to fit your paradigm.

Evaluate said:

No, because each event, even an OS event would cause the need for further validation (beyond just a phone call).

They do followup on OS and PFS by phone after the 36th month visit -- all 36th month visits are complete. It would take ten people an hour to conduct if everyone was home. If someone evented (maybe five patients), they could follow up in a day.

If Dr. Bosch is wrong in saying they will use data (aka: OS and PFS) up to data lock, Innes needs to write an 8K clarifying it, instead of causing confusion by talking on the phone.

[beartrap12]

Evaluate, has the FDA ever seen 3-year data prior to data lock....soft or hard lock ..... presented to them in a cancer trial???? I believe they haven’t, based on all the trials that end as early as they can so we don’t see the tumor returning (think chemo/radiation/CIs.) I think they’ll be blown away with 3-year data, if it’s as good as we’ve seen in the blended data we’ve been presented. And they’ll be blown away by the long, fat tail, if it’s mainly treatment patients, as longs believe. And I think they’ll be so,so happy to get real data beyond 3 years, whether or not the company has to make the official cut off at soft data lock. Compare what we have to offer the FDA to the helmet guys, who presented data up to 2 years, and have since refused to update real time deaths. I think the FDA will be like children on Christmas Day, who think they’ve opened all their presents, then find one more gem.