Shortage of current BCG treatment medication and urgent need for another treatment for Non Muscular Invasive Bladder Cancer. Actual rationing, and splitting of doses as well as flat out refusal due to lack of supply, causing unacceptable level of treatment for patients. High pressure on FDA to pass new treatment before death rate of affected patients significantly increases. Currently past Phase 3, FDA fast tracking and providing rolling reviews. Next meetings and updates scheduled for November, but potential for any moment updates on FDA approval due to pressure being generated and negative press.
Vicinium effectiveness proven with treatment that spares healthy cells. Able to effect cure in an already ravaged bladder following BCG prior treatment. Combination treatments with Durvalumab and Checkpoint Inhibitor for increased treatment of bladder cancer as well as squamous cell carcinoma of the head and neck.
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