IS A REJECTION REALLY THE END OF THE LINE? It seems to me that another IND could be submitted for another type of tumor. This would not be good but maybe not the end of the line
a rejected ind will kill us.get it perfect to ensure acceptence from fda
Pressure is on to get it right. Doesn't have to be perfect as the FDA will give guidance, but it should be as close to perfect as possible. They have to get it right or this one is a cooked chicken alright.
They submit and it gets rejected, flush those shares right down the toilet. PMCB admits in the latest PR that CiaB for IPC is validation of this delivery. They have to get it right first time around. No F ups.