NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

They do not have to go back and do more:

From July 2020:


“These datasets from each of the Trial sites (hospitals) are the largest component of the overall dataset for the Trial and contain most of the data. The remaining information for the overall Trial dataset includes some analyses from specialized service providers who are separate from the Trial site hospitals. Such analyses include, for example, genetic profiles such as IDH mutations. For some of these analyses, it has been necessary to go back and obtain additional material due to the age of the samples. For other analyses, it has been necessary to have the analyses done by two separate experts as a cross-check.

This process continues to be impacted by the effects of COVID-19, especially with the resurgence of COVID cases in many areas. For example, key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. However, the CRO and the Company are working intensively with these vendors on a continuous basis to move as quickly as possible.

The Company currently anticipates that the remaining analyses by these specialty service providers will be completed within the next couple weeks. When this external data joins the now locked data from the Trial sites, the overall Trial dataset will be locked.

Following completion of the Trial data lock, the independent statisticians will be given access to the raw data in the Trial database, and will undertake the calculations and the preparations of the Tables and Listings which provide the Trial results. The Company anticipates that the statisticians’ work will take several weeks.”

https://nwbio.com/northwest-biotherapeutics-announces-completion-of-phase-3-trial-sites-databases/

From April 2020:

“The Company has been working since last year with the contract research organization (CRO) that managed the trial and numerous independent service companies to make the final in-person monitoring visits to all the clinical trial sites (hospitals) across the US and Europe, and to finish collecting and confirming the Phase 3 trial data and resolving queries.

Despite nearly two months (during March and April to date) in which hospital trial sites stopped allowing in-person data monitoring visits and became too overwhelmed to continue helping with data confirmation, the Company’s data collection and confirmation process has continued moving forward in part through workarounds.

The data collection process is including certain epigenetic and genetic information that is recognized as important in Glioblastoma, such as MGMT methylation status. As part of this process, the Company has also identified a method that can potentially enable an additional important genetic factor — IDH mutation status — to be analyzed using bio samples collected years ago during the trial, and to be analyzed in the same timeframe as the data lock. This IDH mutation factor was unknown when the Company’s trial began and through much of the trial period, but has become recognized as very important in recent years.

After factoring in the March and April shutdowns, and the additional genetic analysis, the Company believes it can reach data lock by approximately the end of May.

Upon reaching data lock, the data will be unblinded to the independent statisticians (i.e., the statisticians will be given access to the trial database containing all of the raw data points). The Company will not yet become unblinded at this time.

The independent statisticians will then use the raw data to calculate the relevant measures, such as median survival times and survival percentages at various time points. The statisticians will also calculate various statistical measures and prepare graphs and tables. This work is anticipated to take several weeks. The Company will become unblinded when it receives these results from the statisticians.

The Company will then discuss the information from the statisticians with its expert advisors, including its Scientific Advisory Board and the Steering Committee of the Phase 3 trial. Any questions or comments raised by the experts will be addressed and the results will be prepared for public announcement.”