NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Long:

It is an open question for me whether the PEI got to see the Phase III data - I think it would make best sense that they did so as to make the best possible decision, but that is just my judgment. -- LONGUSA

I referenced the section of the guidance rules (found below) before, but I think this is the framework that NWBO, the DMC, the FDA and the PEI might have used to develop more specific safeguards to accomplish the PEI review you addressed in your quote. (If it occurred)

6.5. Sponsor Access to Interim Data for Planning Purposes
Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities. This interest is understandable, but such access is problematic for reasons already discussed. In general, sponsors are advised to avoid seeking information about unblinded interim data because of the significant possibility that they may wind up impairing trial management or even making the trial results uninterpretable by doing so. Further, plans or decisions based on statistically imprecise interim data may often be suboptimal. Where the sponsor nonetheless has a compelling need to review such information, certain approaches may lessen, although they do not eliminate, risks to the trial:
Discussion of such an action with FDA in advance. This is particularly advisable when the sponsor intends to use the study in support of a licensing or marketing application.
Development of appropriate stopping rules and apportionment of type I error (a) before performing any unblinded interim analysis. This is important because any viewing of study arm-specific effectiveness data by the DMC and/or sponsor in a study of a serious illness raises the possibility that an unanticipated extreme finding of effectiveness might create an ethical imperative to stop the trial, and it would not be possible to quantitate the level of evidence provided by the data if the monitoring plan had not been established prior to data review.
Determination of the minimum amount of information needed. For example, to assist in defining eligibility criteria for a subsequent trial, the sponsor may wish to know only whether estimates of treatment effect in a subgroup are less or greater than in the overall data set.
Formulation of written questions, preferably with yes/no rather than numerical answers, that will elicit only that minimal required information and nothing more.
Receiving only written information regarding the requested data (thereby documenting what was received and avoiding additional unnecessary communications) and abstaining from participation in closed DMC meetings or discussions of data with unblinded DMC members (except as otherwise requested by the DMC).
Identification of those sponsor employees with a critical "need-to-know" and restriction of such information to those individuals only.
Ensuring that individuals with access to the information avoid any subsequent role in the management of the trial and minimize interactions with others in that role.
Ensuring that individuals who have access to such information make every effort to avoid taking actions that will assist others in inferring what the information is.
Ensuring that reports of study findings describe any access to interim data by individuals involved with study management, and steps taken to prevent such access from potentially biasing the study results.