NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

the link in post 45435 did not work for me.

This one did:

http://s1.q4cdn.com/460208960/files/Nov-20-2015_NWBO_Zeng.pdf
which includes:

Update on Phase III of DCVax-L Trial
Recently, some blog articles and social media comments have misunderstanding and wrong reading of
the company ongoing Phase III trial of DCVax-L for newly diagnosed glioblastoma multiforme (GBM). As
such, the company issued a few news releases to clarify and confirm that the Phase III trial is ongoing
per the protocol.
According to our understanding, the company s Phase III trial of DCVax®-L for newly diagnosed GBM is
ongoing and the patients enrolled in the trial are continuing to be treated per the protocol.
The only change in status of the trial is that new screening of patient candidates for the trial has been
temporarily suspended while the Company submits certain information from the trial for regulatory review.
Such screening involves the initial evaluation of patient candidates to determine whether they meet
eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral
diseases, etc.). The Company is in the process of preparing the trial information for regulatory review and
anticipates submission within the next couple of weeks.
The Phase III trial has reached late stage in patient enrollment. Currently there are more than 60 clinical
sites open and operating for the trial across the U.S. and in the U.K., Germany and Canada. The original trial plan involves enrollment of 312 total patients in the trial, and counting 110 events of
tumor recurrence or patient deaths from among these 312 patients to determine whether the primary
endpoint of the trial is met.
NWBO has modified its trial plan so that it will enroll 348 total patients, and will count 248 events from
among these 348 total patients to determine whether the primary endpoint of the trial is met. So, the
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number of events counted in the statistical analysis will increase from 110 to 248, but the total
enrollment in the trial will only increase from 312 to 348.
So far, over 300 patients have been recruited and treated in the trial. And, none of these 300 patients
are in the information arm or the pseudo-progression arm, each of which is parallel with the trial but
outside the trial. As far as what information the Company is submitting to regulators, the company responded that such
submissions would not normally be discussed in the middle of a regulatory process or dialog, and that the
Company plans to report when the process has been completed. This is in accordance with the industry
standard in our view.
Even with the screening delay, we still anticipate that the Phase III trial will reach its first interim analysis
for efficacy in late 2015 or early 2016 and anticipates that the Phase III trial will reach its primary endpoint
PFS (progression free survival) in 2016, potentially in the spring or summer. According to this schedule,
we expect an NDA will be submitted in late 2016 and DCVax-L will be approved in 2H2017.