NorthWest Biotherapeutics Inc (NWBO)

[blue_skies]

NW Bio Provides Update On Projected Timing For Data Lock For Phase 3 Trial of DCVax®-L for Glioblastoma Brain Cancer

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs. All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually). The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations. After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.

In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process 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.

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. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

Too many qualifiers providing LP with plenty of wiggle room and she does know how to wiggle.

A follow up press release with a realistic timetable keeping everyone current would be the professional thing.

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.