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another good night on nasdaq, page-49

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    Rather than accept you were wrong on the previous post, out comes another red herring.

    Let me see if I can explain this for you (everyone else seems to understand).

    CAN003 is the Phase 2b trial. The final results will be announced within 3-4 weeks and confirm the efficacy of Cvac on the basis of PFS v's the Standard of Care.

    CAN004 is a combined Phase 2 and Phase 3 trial. The Phase 2 component is to pick up the required placebo arm while the Phase 3 component provides the FINAL efficacy confirmation, within a statistically powered trial.

    Excerpts from the Trial website below should help you spot the difference, assuming that's not a waste of your time:



    CAN003
    Primary Outcome Measures:
    •To evaluate the safety of Cvac administration in this population. [ Designated as safety issue: No ]

    •Progression Free Survival [ Designated as safety issue: No ]


    Secondary Outcome Measures:
    •Overall survival [ Designated as safety issue: No ]
    For eligible patients that have completed or terminated the study, the collection of Overall Survival data will continue through October 2015.


    •Evaluation of immunologic parameters subsequent to Cvac administration.


    CAN004
    Primary Outcome Measures:
    •Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of radiological scan used to determine PD, evaluated every 8 weeks after baseline.


    Secondary Outcome Measures:
    •Overall survival (OS) [ Designated as safety issue: No ]
    Assess Cvac as compared to placebo for overall survival


    •Assessment of safety and tolerability of Cvac as compared to placebo [ Designated as safety issue: Yes ]

    •Assessment of health-related quality of life questionnaires(QoL)
 
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