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gambinilive

10/29/09 11:01 AM

#2147 RE: gambinilive #2146

Multikine® Phase III Clinical Trial Design

Study Summary: A Pivotal Phase III, Open-label, Randomized, Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity Versus Standard of Care Only.

Objectives: The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to Standard of Care (SOC) as measured by overall survival. The secondary objectives are to evaluate the effects of Multikine® treatment on the cumulative incidence of local-regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, while confirming Multikine® safety.

Number of Subjects: Approximately 800

Clinical Centers: 40 - 50 (globally distributed; North and South America, Europe, Asia)

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richme

10/29/09 7:15 PM

#2160 RE: gambinilive #2146

How come the unbridled largely unsubstantiated optimism is alright? Would it make you feel better if we all started pulling figures out of the clear blue and raced up the CVM flagpole calling for PPS of 3.00, 4.00, 5.00, $10.00, $20.00, $30.00. Would that work?