All good info that is very much needed to straighthen out the um .... speculation in the mb. Line in the sand. The mgmt is not dragging feets anymore. Thanks Umibe.
3. Data-lock is planned for end of May. At data lock the trial will be unblinded at the same time. That is what LG said. The data will be analyzed by the statisticians and other external parties for 2 weeks and then turned over to NWBO. NWBO will do checking and carefully go over the data and plan for best preparation for TLD announcement. They will consult with the SAB and their own consultants and this will take three weeks. The whole presentation and announcement should be available by the end of the first week of July, 2020.
Slight clarification. At data-lock (assumed to be by end of May) the trial will ONLY be unblinded to the independent statisticians.
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. Based on these expectations, and taking account of the two months lost in March and April, the current estimate of public disclosure of top line data would range from the end of June to early July.
So: * end-May: unblinding to the independent statisticians * a few weeks later: unblinding to the company * end-June or early-July: public disclosure of top line data