Is the MCNA Adcom Aware of this?You are reading this correctly, follow investors. A single-arm trial for BCG refractory NMIBC with 122 patients enrolled was started in
May 2015 by a seperate company. According to the adcom that reviewed MCNA in November, a single-arm trial with a small patient size does not provide a significant enough sample size to convince on efficacy......even though the FDA continues to allow NMIBC single arm trials due to the inherent difficulties of double arm trials, which the FDA confirmed in their 2013 workshop to discuss NMIBC trial design. I'm sorry folks, but I am forced to believe that the right hand (FDA) does not know what the left hand (Oncology Adcom) is doing because both groups are giving mixed guidance.
https://clinicaltrials.gov/ct2/show/NCT02365818
| Estimated Enrollment: | 122 |
| Study Start Date: | May 2015 |
| Estimated Study Completion Date: | June 2019
Purpose: To study the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy. |
AN OPEN LABEL, SINGLE ARM, PHASE III, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF CG0070 ONCOLYTIC VECTOR REGIMEN IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CARCINOMA WHO HAVE FAILED BCG THERAPY AND REFUSED CYSTECTOMY
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