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Re: Sankarad1 post# 29846

Tuesday, 02/24/2015 9:53:19 PM

Tuesday, February 24, 2015 9:53:19 PM

Post# of 726297
Anticipated Milestones and Catalysts in 2015

DCVax-L Phase III Trial Program
• Expansion of the program
• First interim analysis for efficacy – independent DMC review
• Completion of patient recruitment
• Ongoing follow-up on 55 “Information Arm” patients
• Accumulation of “Events” for primary endpoint
DCVax-Direct Trials Program
• Completion of patient treatments and data from Phase I trial
• Obtaining regulatory approvals for expanded DCVax-Direct treatments
• Launch of at least 2 Phase II trials and potential completion of enrollment
DCVax-L Early Access Programs
• UK Early Access to Medicines Scheme (Stage 2/Decision), and Specials Program
• German reimbursement and pricing
• Expansion of manufacturing; distribution/logistics; contracts; gradual ramp-up
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