Replies to post #10365 on Elite Pharmaceuticals Inc (ELTP)

[Hike]

My questions and answers from Dianne:


1) Has Elite received the final go ahead yet to make Naltrexone and Hydromorphone? The CBE 30 had been holding us back.


Nothing has been announced. This would be material information and the company would be required to disclose this information within four days of such notification.

We had originally filed a CBE 30 with the FDA on the hydromorphone product. The FDA responded that they reclassified the supplement to a “prior review”. A press release was issued on June 6th.

2) Has Elite begun making and shipping Methadone?

It was disclosed in the last quarterly conference call that Elite expects to begin shipping methadone before the end of the month. In order to do so, it would be fair to conclude that they have begun manufacturing by now.

3) Is it true pharma companies in Europe take a month off at Easter?

Don’t know. I do know Europeans take many more holidays than they do in the United States.

3) Is Elite about to begin human testing of ELI-216?

The last information that was disclosed is that Elite plans to secure a marketing partner before beginning the final clinical trials.

The scale up of ELI-216 certainly will help in securing a partner.