Replies to post #234253 on NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

you wrote:

Dr. Bosch stated that before you look at the data, you have to have the SAP etched in stone in order to preserve the integrity of the analysis. Do you understand? See his presentation at 38:30.

I did go back and look at 38'30 in his presentation, and you are right that he indicated that the SAP has to be etched in stone before you "look at the data".

However, at 36'20 MB indicates that in parallel there is a lot of activity going on. They have a CRO & "they hold all the data", "in a separate database that only they have access to", and they are continuously checking and validating the data".

So my current thought is that the data that the CRO is reviewing (blinded to NWBO) is the data that is produced as a result of the Soft Lock.
Then the CRO and auditors go to work on cleaning up this data, and doing their queries and verifications etc .... in parallel (or simultaneous with) ... whilst NWBO is working on the draft SAP & working to get it finalized (without being influenced by the soft lock data that only the CRO has access to).

[sentiment_stocks]

Bosch's meaning is that they will UNBLIND after data lock. They have LOOKED at the data, but not unblinded it. They are scrubbing the BLINDED data, and when the SAP is ETCHED IN STONE, they will unblind it.

Soft data lock occurs in January 2019. Then they gather it and scrub it and answer queries and examine their navels or whatever else this tedious business entails while they wait for the SAP to be FINALIZED. And when the SAP is finalized, it's "etched in stone" and they can THEN unblind the data. But the data that has been scrubbed and that will be what forms the content of the hazard ratios and p-values and mid-points and k-m curve possibilities of survival, etc., etc., will be based on what happened previous to the soft lock. What happens between the soft lock and the formal data lock will be additional data that won't be lost, but won't be part of what makes up the formal unblinded trial data.

This is how I understand it and what I think DI is saying on his phone.

Dr. Bosch... ASCO

37:59
Now what is an SAP? It’s actually a document, though it can be a hundred pages, or several hundred pages. It contains all of the planned analyses for the data that will come from the Phase 3 trial. Those analysis can be the primary analysis for a primary endpoint, the supportive analysis for a primary endpoint, all of those analyses for your secondary endpoint, for your supportive endpoint, for your safety endpoints. It contains the sensitivity analyses, all of those are spelled out in minute detail so that before you actually take a look at the data, you have basically “etched in stone” how you’re going to analyze your data to preserve the scientific integrity of the analysis.

So an effective SAP considers the original trial design, the protocol, and subsequent scientific advances. If one were to ignore those, you run the risk of not properly analyzing your data. And therefore, what you get with the SAP analyses, what they provide is insight into the effects of the treatment, course of the disease, and on survival of the patients in the trial.

https://nwbio.com/update-on-dc-vax-at-asco-2019/