Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Nasrat best not pull Isradipine from Epic with this "PD" trial about to conclude !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

He will not get the FDA to approve a site transfer for who knows how many YEARS and "IF" he ever did, market share will be gobbled up by Teva and others

Isradipine is already manufactured at Elite's Northvale plant.





https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141631365

If isradipine becomes a major drug for Elite, it will be 100% thanks to Nasrat. First, it is a Mikah drug. But even beyond that, this drug has been Nasrat's baby. It was the only drug of the 12 that were contracted with Epic that he took back from them. He let 10 of the 12 sit on the shelf, but isradipine he took back. He brought Doug Plassche over in good part because Doug was familiar with isradipine manufacturing. Even then, it was quite an ordeal to get it out the door. Quite a lot of trouble for a $5 million dollar drug, so no doubt, Nasrat understood the significance of this one old drug, certainly above all the other Mikah drugs. He made sure this drug got on the shelf, and if STEADY-PDIII results are good, Elite will do very well. Nasrat will deserve all of the credit.

Nasrat Hakim 8/14/14:

The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.

Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another check for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.