Reason #3: Approval May Be On The Horizon
In general, for new drugs to hit the market, they must go through preclinical trials as well as Phase 1, 2 and 3 clinical trials. However, in some rare cases, drugs only go through one or two clinical trials before the FDA fast tracks them to approval.
ADXS-PSA may prove to be one of these rare cases. With such positive results being shown in a patient population with one of the most grim diagnoses, the FDA is likely taking note and ADXS is likely considering pushing for fast tracked approval.
At the end of the day, these types of actions only happen when a new drug shows promise in an indication with a desperate patient population. That’s exactly what we see here, and not only are the results positive, they are far and beyond what anyone would have expected.
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