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John_Langston

04/06/15 6:39 PM

#150157 RE: Satman #150152

Just thinking outside the ELTP is going to the moon “box”. I have seen tens of thousands of the moon ships crash and burn bad but then again ELTP could be the one in a galzillion.
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Couch

04/06/15 7:52 PM

#150174 RE: Satman #150152

why do you think the FDA will shun them?


Elite has passed every single ADT study and trial it has ever conducted with flying colors and that can be backed up with data, links, press releases, conference calls and Nasrat's reputation that he has earned with 30 years in the majors. Nasrat has already stated that nobody is going to stop us not even the FDA. Guess we are going to find out.....but the FDA isn't going to shun Elite. To say otherwise is more misinformation and we all know it. Not even worth .02 cents.

https://clinicaltrials.gov/ct2/show/NCT02401750?term=%22Elite+Laboratories%2C+Inc%22&rank=2

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.