IMU is using the current VAXINIA clinical trial to demonstrate safety as the primary end point and then efficacy as secondary for multiple solid tumours, expansion to other indication like they did for bile duct and recent hint of possible bladder solid cancer market means they see efficacy and more importantly the FDA see safety foremost and then efficacy to allow the clinical trial expansion to start with the highest dosage. This was how IMU received Fast Track designation for Bile duct.
Why IMU is a multi multi bagger, page-25548
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