Northwest Biotherapeutics ( NWBO) needs to get its story straight on the whereabouts of the interim efficacy analysis of the DC-Vax phase III study in brain tumor patients.
On Wednesday, Northwest Bio issued a press release denying the existence of the DC-Vax interim efficacy analysis:
The Company confirmed, yet again, that no interim analysis of efficacy relating to the Phase III trial has been conducted at any time. [Emphasis mine.]
But Northwest Bio tells a different story in its most recent 10-K filed with the Securities and Exchange Commission:
In December 2013, we announced that the number of events required to trigger the first interim analysis of the Phase III clinical trial had been reached. This milestone is measured by "events," which are defined as either a tumor recurrence or a death. With the current trial size, the pre-specified trigger number for the first interim analysis is 66 such events, comprising 60% of the 110 events required to reach the primary endpoint of the Phase III trial. The interim analysis will be conducted by an independent Data Monitoring Committee, or DMC, with assistance from the independent clinical research organization, or CRO, managing the trial. In March 2014, we announced that the DMC has conducted a review of the safety data, and recommended that the trial continue as planned. As we also announced the DMC’s interim analysis of efficacy data remains outstanding. [Emphasis mine.]On March 7, Northwest Bio issued a press release with similar language: "The DSMB’s review of the [DC-Vax] efficacy data is still pending."
Which statement is the truth? The efficacy interim analysis of the DC-Vax study has not been conducted "at any time." Or, the interim efficacy analysis "remains outstanding" or is "still pending."