Elite Pharmaceuticals Inc (ELTP)

[lasers]

toybaby exactly the question(s) that need to be answered.

FDA Commissioner Margaret Hamburg approved ER Embeda in 2009 and was all set to approved IR SequestOx based on guidance to $ELTP during 2014/2015. She was responsible for SequestOx's "priority review " PDUFA which allowed 6 months Jul 2016 review vs 12 months schedule Jan 2017, for ordinary review. She had repeatedly rejected Troxyca.

Commissioner Califf began in Feb 2016 and on Aug 19, 2016 approved Big Pharma Pfizer Troxyca and CRL delayed Small Pharma $ELTP SequestOx.

The fact is that ER Troxyca Oxycodone absorption when taken after a "fat meal" would be delayed longer with its time release polymer encasement than IR SequestOx Oxycodone absorption.

The FDA allowed Pfizer to use "food specific" applesauce Phamphlet Instructions for "swallowing" ??? which should have been a CRL redesign smaller capsule IF swallowing was really an issue. No other ER opioid drugs has any such pamphlet instructions.

Yes the questions need to be answered!