Wednesday, July 08, 2020 1:05:51 PM
From the April 18th, 2020 Press Release:
https://nwbio.com/nw-bio-to-discuss-projected-schedule-for-data-lock-unblinding-and-top-line-data-from-its-phase-3-clinical-trial-at-annual-shareholder-meeting/
“The Company believes it can reach data lock by approximately the end of May.”
“Based on [their] 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.”
It’s July 8th, 2020.
Articulated NWBO timeline:
DL = End of May
TLD = June to early July
It’s July 8th, 2020. (DL has been missed; presumed TLD will be missed).
From the June 2nd, 2020 Press Release:
https://nwbio.com/nw-bio-provides-update-on-projected-timing-for-data-lock-for-phase-3-trial-of-dcvax-l-for-glioblastoma-brain-cancer/
“In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process [final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs] may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April [April 18th, 2020]
“If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later.”
“It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.”
“Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.”
“If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.”
Articulated NWBO timeline:
DL = Changed from End of May to After Mid-June (soft lock)
TLD = Changed from June/Early July to after soft lock + unblinding statisticians and carry out analyses (“several weeks”) + deliver/unblind the company + discuss with SAB and SC and address comments/questions (IMO, ~4 weeks) thus deduce first or second week of August.
It’s July 8th, 2020. (DL has been missed; presumed TLD will be missed). Company has not provided any additional update bulletins”.
It’s July 8th, 2020.
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