Elite Pharmaceuticals Inc (ELTP)

[Couch]

LMMFAO!!!! Read Carefully!!! - TELL ME what IMMEDIATELY means. LOL!!!

Let's be HONEST - NASRAT is THE MAN!!! - NOBODY will STOP US $$$$$$$$$

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82830&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."

As far as SequestOx is concerned, we ran multiple in vitro trials that simulated set conditions and created three options supported by data. Wrote a report and a proposal to the FDA that contains a path forward that in our opinion will make Elite’s product work and efficacious irrespective of food intake.

They FDA is studying our proposal, and they will give us feedback soon. They have given us a date to meet us in the third week of December. We believe that our proposal will address the FDA Tmax concern, and if they agree with our proposal and we will know that next month, Elite will complete additional work and a fed BE study and target resubmission in 2017. We will know more after we meet with the FDA.

Finally Elite is in the best financial shape in her history, has the best infrastructure ever and most importantly an excellent pipeline that is so charged up that it is becoming a little forgiving. It allow us to tolerate regulatory delays, and less-than-perfect performances, and it is still forgiving enough for us to be able to get the fundamentals necessary to get to dollar land and get into NASDAQ.