Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

During the last cc they mentioned they had 30 days to respond to FDA on Perc and Norco. I assume Sungen product got delayed. I am ASSUMING they responded in time. Nasrat clearly mentioned that if they didn’t respond timely they would have to get in the back of the line...

I looked back at the CC transcript, and he did confirm that they had "just filed" their response for Percocet CRL but not yet for Norco, which he hoped to do "within the next couple of months." That was on November 10. So we could hear about Percocet any day, but Norco is probably further out.


There is no 30 day response requirement for a CRL. The 30 day response time is for new applications. He seems to be referring to the ANDA for the undisclosed generic opioid, which we presume to be methadone. When the company submits a new ANDA or NDA application, there is a back-and-forth process to correct minor errors before the application is "accepted for review." When the FDA asks a question about a new application, the company has 30 days to respond.


They submitted generic OxyContin ANDA on September 20, and Nasrat says that by November 10 they had not gotten any inquiries from FDA about it. Remember, once the FDA accepts the application for review, then Elite has 20 days to notify Purdue, and once Purdue receives notification, they have 45 days to file suit. They can still sue later, but they would not get the automatic 30 month stay from FDA. Sounds like it is still a little too soon to say much about this application or Purdue's response to it.






https://seekingalpha.com/article/4123694-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q2-2018-results-earnings-call-transcript?part=single

Nasrat Hakim 11/10/17

Let me try this into our pending applications to-date. We have filed four ANDAs, Oxy APAP, Hydro APAP, non-disclosed and OXY ER. We received a complete response letter that defined exactly what more does the FDA want. The requirements range from, A, make a commitment that you can comply with elemental analysis which will become the law of the ANDA in 2018. We did. Provide the additional testing for certain things. We did. Do a micro on the specific things. We did. We just filed our response to FDA’s complete response letter for OXY APAP and we will file the response to Hydro APAP hopefully within the next couple of months.

FDA has hardly asked a single question about the undisclosed application the last night. Late p.m. yesterday they sent us the inquiry asking a host of questions and gave us 30 days to answer them. We have not received any inquiries yet on Oxy ER.

Just to put things in perspective for you. During Q4 of this year, in addition to having to prepare to file and we will file the SunGen application in December of this year. In addition to that, we have to response to the FDA for Oxy APAP. We are responding for Hydro APAP and we are responding for our undisclosed, all within couple of months, that’s a huge burden on the staff especially when the FDA give this specific time you get to respond in 30 days or you are in the back of the line, okay. So we are doing a lot of work in here and this is why it takes a little bit of time to put the response together and sent it to FDA.