Replies to post #202277 on Elite Pharmaceuticals Inc (ELTP)

[Gman24]

I feel it is rather a simple deduction but not a fact. With the FDA's calendar presently full from now until after our July 14th date and the fact that we have not been given an AdComm date as of yet coupled with the many examples of other pharma receiving their AdComm dates 45-60 days in advance of approval date. We can conclude Elite will not be needing an AdComm meeting. Unless the FDA squeezes one in on top of their current schedule. Which I do not see happening. I just think all the political pressure is helping here.

[lasers]

KravMD most certainly know that you as well as all of $ELTP shareholders have waited years for SequestOx.

Sarepta new IND is a very special case for an Orphan Disease that there is no SOC.

In the following example it seems the company submitted information after the fact resulting in an amendment of the NDA. As far as we know this isn't the fact with Elite and SequestOx.

As of May 26,2016

At the FDA panel hearing in April, parents gave emotional testimonies about how they believed their children have benefited from eteplirsen. Despite the testimonies, the panel voted 7-3, with three abstentions, that the drug's data -- which was based on a single study of 12 patients -- wasn't enough for approval.

The 12 patients is simply not enough persons to draw conclusions. The ADCOM and the FDA have voted again to request more data with a second delay on this new molecule.

However absolutely no comparison to $ELTP SequestOx delivery system of Agonist and Antagonist where over the past 2 years,the 40 person HAL and 163 Person P3 bunionectomy were as directed by the FDA. Remember it is SequestOx delivery system on trial and not the Oxycodone and Naltrexone which are well known for many years. There are ZERO new molecules on trial.