|From: danawa (Rep: 58)||Date: 10/22/2018 14:43|
|Forum: ONCOSEC MEDICAL - Msg #230||Thread #674043065 (Rec: 0) |
| latest 10K, market response very positively to this update to ONCS Pisces trial |
"Based on the preliminary tumor response data and safety profile observed to date, we have eliminated the formal interim Simon stage 1 analysis. The distinguishing feature of the Simon 2-stage design is sample size minimization. Phase 2 clinical trials using this design enroll a relatively small number of patients to allow a preliminary assessment of a new intervention before conducting a larger trial. Since preliminary tumor responses and correlative immunological data have been observed, we believe that eliminating the formal analysis and expanding the sample size is warranted. We believe that this may also accelerate the completion of the study and avoid any unwarranted interruption in continuous enrollment which may occur. We are planning to increase the number of patients to be enrolled from 48 to approximately 80 patients. We believe this will provide for a more robust data set and may further enhance our ability to seek an accelerated approval, should the final data results support doing so. We continue planning to complete enrollment of all patients by mid-2019.
Lastly, based on the outcome of the study and feedback from FDA, we plan to file for accelerated approval with the FDA for this patient population by the end of 2019 or early 2020."
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