Replies to post #270449 on Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

What??? Where does it say FDA received the response?

[lasers]

$ELTP's FORM 8-K was filed Thurs 2017-09-07.

http://ir.elitepharma.com/profiles/investor/secDL.asp?b=2258&c=1053369&ID=000114420417047068/0001144204-17-047068

Item 8.01 Other Events.

Elite Pharmaceuticals, Inc. ("Elite" or the “Company") received a Complete Response (CR) from the U.S. Food & Drug Administration (FDA) for its Percocet generic ANDA application. The FDA stated that the response to “the CR letter will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR.” Elite intends to submit a “MINOR AMENDMENT” shortly to address the deficiencies listed. The Percocet generic ANDA submission was received for review by the FDA in November 2016.

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$ELTP has seven days from receipt of the FDA CR MINOR AMENDMENT, for the original Aug 10, 2016 filing, to respond and be received by the FDA.

$ELTP Percocet original filing was

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82211&GoTopage=1&Category=2163&BzID=2258&t=2054&G=939

and it was "officially received" by the FDA for review in November 2016. $ELTP likely received the MINOR AMENDMENT CR FDA document earlier this week. Since $ELTP has seven days for the FDA to officially receive the response, it has likely already been sent to the FDA or is imminent.

[WeeZuhl]

Don't be distracted.

From WeeZulh's link the FDA has "officially received" $ELTP's Percocet filing and $ELTP has seven days to correct the FDA cited "Minor Amendment" for the FDA to proceed with formal approval and follow-up new Inspection if required.

The link in my post refers to a different step in the process. When the application is submitted by the sponsor, there is an initial review for completeness. The link is to the FDA's guidance for what can be corrected during this initial stage, up to nine minor problems of many different types can be corrected before the application is formally received by the FDA to start a review cycle. In this initial step, when the FDA identifies a minor problem, the sponsor has seven days to respond. This process goes on until every point of review has been checked off, and then the application is received for review. It's a smart process, because any one of the corrected problems would have caused a CRL at the end of the review cycle. Who cares if it took three months? Oh no, three whole months of working with the FDA to give them exactly what they want. That's dumb. Take as long as is necessary to make the app as clean and pretty as a rose in the rain.


Don't get distracted by straw man arguments! The CRL for Percocet is the first news about Elite to make me smile in a long time. Pessimists out there know exactly what I mean. I never bought into the claim that ANDA's would be reviewed in 10-12 months. I thought it was bull. The average was 36 months and some went much longer, so 12 months seemed optimistic. But FDA completed the full review cycle in less than 10 months! While any CRL is disappointing, a MINOR DEFICIENCY is easily fixed, and a MINOR AMENDMENT is quickly reviewed. Suddenly we have a finite time-frame for Percocet, and we also know the Norco ANDA is close behind. As of yesterday, we had no idea about these drugs. This filing is great news for our very near future and for every one of our drugs in development (several of the SunGen drugs should be close to submission). For the first time in a long time, we can move up the time-frame for great success, instead of moving it back. Don't let silly rants about three months of review cause you to miss the true meaning of this important development.