It's hard to predict whether any drug will eventually be brought to market at this stage of development. The data presented was nothing new, but once again pointed to the rationale supporting CLDX 's continuing its development toward a registration pathway..........within a select patient group in the general breast cancer patient population ( see below ).
Based on this early data it seems fair to assign this product ( my personal speculation only ) a 50 / 50 chance or somewhat better that it may reach initial marketing in the setting of triple negative breast cancer with high GPNMB expression.
Conceivably, the bar or threshold for an approval in this patient population would be lowered to begin with as present therapies are not that effective and there is a distinct clinically unmet need.
The FDA would be hard pressed if they turned it down for triple neg breast indication because all know other drugs were tested head to head and they met 0% responce rates. That 's provided no significant side effects. My opinion sise effects or not, those patients are doomed without it so it's worth the risk and as far as I've heard, the side effects are minimal.