Securing the NUB and what looks like approval for the Govt backed " Evidence with Benefits" trial where the trial is funded to establish clinical utility/ benefit at a specified price point, is a positive outcome. What needs to be understood is the detail; understanding the trial design; endpoints; what the comparator arm chemo therapy is (is that std of care in Germany or globally); patient numbers status etc. If the trial is powered appropraitely then a positive outcome will be one meaningful step towards success. If the trial were to be negative what would that mean for Oncosil in LAPC ? . The devil is in the detail, smart trial design, patient selection and statistical analysis. One way or the other the question will be answered.
Ann: Fully-Funded Trial Approved In Germany, page-7
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