Elite Pharmaceuticals Inc (ELTP)

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$ELTP ADFs are solid multi-Patented, solid Pharmacological 2-bead technology that can use any amount of Naltrexone ranging up to 50 mg and more with rock steady stability.

$ELTP has worked very closely with the FDA for the past 2 years in providing the exact amount of Naltrexone in SequestOx meeting both FDA ADF labeling approval as well as keeping the Pharmacy $cost down for the public. The $ELTP Data provided for SequestOx has to be the most thorough with nothing more to be added.

IMO,it is beginning to look more and more that the FDA may not need to use the 20 person advisory Committee of outside Pharma consultants to help the FDA with their PDUFA decision for SequestOx scheduled for Jul 14, 2016!!! It has been done in the past when the FDA itself is thoroughly familiar with other NDAs.

We will continue to look for the 20 person Advisory Committee scheduling but as of yet, none have been found in either May, Jun, or Jul for SequestOx, with only 2 months to go for PDUFA of Jul 14.