Elite Pharmaceuticals Inc (ELTP)

[BuddyGuise]

Eli-200 Timeline

Key statements from CEO Nasrat Hakim during Q1'15 CC

In order to launch a product, especially an anti-abuse product, NDA, you have to have a robust successful formulation. That requires a lot of work, reproducibility and long-term stability on accelerated temperature. We have that and that was very successful.

The second thing that requires bioequivalence trial, you got to compare your product to a comparator that the FDA knows often has tested before, have tested the product before. That was very successful and we’ve done that as well, that was the trials that we went through in January of 2014.

After that, you have to comply with the FDA’s guidance on anti-abuse.

The first category is the lab in vitro anti-abuse.

We were talking about trying to mimic what a person who wants to abuse your product at home. Very important work that has taken us at least seven months and we will be done with that in September and we will announce that works for you late September, early October and it will be ready for us deliver to the FDA.

The second two categories are the human abuse liability trials.

Again, these are long-term extended trials from the time we started writing protocols till we will have data. It will probably take between seven and nine months. These are clinical trials where people will actually take our
product.They cost millions of dollars and they are handled by a Canadian entity that had to have the approval of the Canadian Government as well as the FDA.
Again, the results hopefully will be done sometime toward the end of September (PR'd 9/9 ELITE PHARMACEUTICALS RELEASES POSITIVE TOP LINE HUMAN ABUSE LIABILITY DATA FOR ELI-200), we’ll have a preliminary number. We will issue a final report somewhere around October. So the human in vitro studies and the in vitro studies will be ready before October.

Why I am giving you these dates, because I am pushing this back on all the consultants to have them ready before we go to the FDA, pre-NDA meeting in October.
I need them to evaluate these and tell us if there is anything missing, so we can take care of it before the filing date of December 2014.

Next step, what are we thinking about once we file. We believe the FDA will grant us expedited review and we’ll give us results probably by – or approval by September of 2015.