Since NGSX utilized a 4% over-the-counter (OTC) lidocaine cream as a numbing agent to reducing burning before applying Qutenza, the Company may be required to conduct a small study testing an officially FDA-approved topical anesthetic along with Qutenza prior to the FDA granting approval, which could result in a minor delay to the mid-August PDUFA date by a few months.

Although after the submittal of this small study, FDA might take class - 2 action ( 60 days) to review it But this one is definitely a candidate for BIOTECH portfolio

I am long on this.