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NW Bio Responds To Shareholder Inquiries Following Immune Therapy Sector's Recent Market Decline
Date:12/16/2013

NW Bio's Phase III trial is also potentially powered for the secondary endpoint of overall survival (OS), and it has an interim analysis devoted solely to reviewing the size of the trial, which can enable increasing the size of the trial if desired.  In addition to all these measures, the trial has built-in analyses of specified subsets of the patients in the trial.

In contrast, the Competitor's trial was a 124-patient Phase II trial.  It was approved by only one regulator (FDA) and conducted only in the US.  According to the Competitor's description of its trial, the trial was designed with a target of 9 months' difference in overall survival between the treated arm and the control arm in the trial.  It is unclear to what extent a cushion was built into the statistical powering in this trial design.  

Company Positioning Differences.  NW Bio has undertaken years of work and devoted extensive resources to building many chances for success.  The Company now has two potential major value-driver programs under way in parallel:  its lead Phase III trial with DCVax-L for GBM brain cancer, and its large (60 patient) Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors with a particularly significant efficacy endpoint (regression of existing inoperable tumors). 

Each of these parallel programs are expected to have ongoing catalysts throughout 2014.  Each of these product lines has the possibility for broad market potential:  DCVax-L potentially for all or most types of operable solid tumors (i.e., tumors in any tissue of the body, which can be surgically removed) and DCVax-Direct potentially for all or most inoperable solid tumors (i.e., tumors in any tissues, which cannot be surgically removed).  NW Bio has also painstakingly built its operations on two continents, in both the US and Europe – including
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SOURCE Northwest Biotherapeutics
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