Elite Pharmaceuticals Inc (ELTP)

[Couch]

POINTS OF INTEREST FROM THE CC: Nobody can Stop US!!

1) Elite is moving from a small reporting company to a mid sized reporting company!

Smaller reporting companies have market caps of less than seventy five million dollars. This year, for the first time, at September 30thour market cap was above seventy five million dollars. So as of September 30th, we had a market cap of a hundred and ninety million as compared to just sixty one million a year ago. So the market cap more than tripled and our stock price increased almost as much; from twelve cents to thirty-two cents in the year

2) The longstanding Bond Debt Default issue is no longer a problem!

We retired the Series B, which had a 9% interest rate and we caught up on all payments that were due on the Series A, 6-1/2% bonds. That was a total of 1.1 million dollars paid to the bonds to bring us current during the quarter. This removes a major threat tothe company’s ability to operate as a going concern. This results in a 3.2 million dollar increase in working capital.

3) Isradipine expected to launch within this calendar year and another generic by the end of this fiscal year.

4) Successful Eli 200 Human Abuse Liability Trial & BE study!! AND enough CASH to file & commercializeEli 200!!

You look at the balance sheet, 7.6 million in cash, 4.1 million in working capital and 2-1/2 million dollars in inventory. These are the resources and the critical math to support the financial requirements of commercializing ELI-200 as our first abuse resistant opioid. The resources are in place and they’re inviolable; and that’s a big deal.

ELI-200 has undergone vigorous testing and clinical trials and lab trials this year. We definitely have a successful formulation and technology. We have passed the B.E. test, we are bioequivalent; we have placed registration batches on six month accelerated and twelvemonth room temperature stability. The six month accelerated and nine month are done. The twelve month will come out next month and the data looks solid. We filed an IND and havebeen in constant communication with the FDA and are receiving feedback from them.

5) Elite is continuing to greatly expand its ART based operations IN HOUSE!!

We had extensive R&D batch manufacturing to support clinical trials as well as significant optimization work, on what I’ll call the next generation of the key intermediate. The formulation looks excellent. Stability results look good and we’re ready to start factoring this next generation into the rest of the portfolio products as we proceed. We purchased and are preparing to install a commercial scale fluid bed processor with the capacity of approximately a 1000 kilos a batch; versus our current maximum of 200 kilos per batch. With this capacity we should be able to achieve our target for ELI-200 and possibly the second product as well, depending on the market penetration.

6) Nasrat Hakim has complete confidence in Elite launching Eli 200 and partner or go it alone!!

The FDA has never seen a product like ours before. Therefor we need to negotiate with them what would make them comfortable. I have anticipated that, what could possibly happen and I’ve stated before, and I will state it again, no one can stop us; we are going to get an approval and we’re going to commercialize this product and I’ve always said, FDA may delay us by a few months but they will not stop us. And I do believe we are still going on that path. This is why we are preparing the commercial scale launch. We are updating the facility and we’re working very closely with the FDA.

The issue to me is the right deal. I’d much rather go at it myself than have a bad deal with somebody that wants too much or wants to own a spot of our technology as a result of that.I think we’re going to make it regardless; one of the models we have is to partner with some of the others. We got the money, we got the Lincoln Park, you’ve got your guy’s support and we can go at it by ourselves.

7) Elite has been in regular contact with the FDA in regard to Eli 200 including receiving word that Elite will be given expedited review for Eli 200!!

There are two parts of meetings we hold with the FDA. There are answer and question meetings where they commit to give you a --within a certain time if you don’t meet with them in person. And there is the face to face. In October they gave us responses in writing. In November, and they agreed to the date on the 17th, which was the one where we were face to face. So both of them did take place, each one was a different forum.

This one depends on what’s initiated with FDA. I can only give you my personal guess. I think approval; they have stated in one of their correspondences with us that they will give us expedited review.

8) Elite has the first of its kind ART product and the FDA was very positive towards Elite in its face to face meeting.

The FDA’s attitude was positive. They were very complimentary on the CMC section. They were very agreeable. They were really trying to do the right thing; we were asking poignant questions. They answered what we could and others they said, “well we need to think about it together.” I felt that they want to help us get the product to the market, but again they want to make sure because this is a first of its kind, that they are comfortable or maybe a little of even conservative in getting us there.