Elite Pharmaceuticals Inc (ELTP)

[rrr2003]

Couch is correct. You are very wrong on this one. Nasrat was referring to ELI-200 when he said nobody could stop ELTP from receiving an FDA approval.


http://seekingalpha.com/article/2696615-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q2-2015-results-earnings-call-transcript?part=single


Our focus remains on ELI-200. The ELI-200 had undergone vigorous testing and clinical trials and lab trials this year. We definitely have a successful formulation and technology. We have passed the bio BD [ph] test here bioequivalent. We have placed registration batches on six month accelerated and 12 month room temperature stability. The six month accelerated and nine month have done, the 12 month will come out next months and the data look solid.

The third item I would like to update you on is our FDA meeting and this will be a very high level update obviously because we have not issued the press release and we have not worked out all the details with the FDA. All the attributes I just highlighted have been presented to FDA in one form or another through the IND or our meetings and everything is positive. FDA has never seen a product like ours before. Therefore we need to negotiate with them what would make them comfortable. I have anticipated that to possibly happen and I have 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’re preparing the commercial scale launch, we’re getting the facilities and we’re working very closely with FDA.