Hopefully $ELTP shareholders realize that the Percocet review by the FDA is a normal review taken when the FDA has signaled that they are proceeding to approve the ANDA drug.
New Commissioner Gottlieb has his guidelines and he is most definitely imposing these guidelines as the new Sheriff in town.
The FDA CR Minor Amendment received by $ELTP for Percocet will NOT delay their Percocet approval timeline. While $ELTP filed Percocet on Aug 10,2016 the FDA did not look at it until Nov 2016 and then awarded it for preliminary approval and a go forward with it.
IMO a Oct/Nov 2017 FDA approval, which would be 12 months since the FDA preliminary approval on Nov 2016, is a very likely scenario.
Acetaminophen API storage, handling, and documentation is of concern because of its chemical properties and Gottlieb may be imposing higher requirements, concerning Temperature, Humidity, and Documentation control.
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