Elite Pharmaceuticals Inc (ELTP): Basically there are two scenarios. FDA s...

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Re: A deleted message

Wednesday, 11/19/2014 2:54:14 PM

Wednesday, November 19, 2014 2:54:14 PM

Basically there are two scenarios. FDA says they want an efficacy trial. Elite will pass as Opioids relieve pain and have known to do so for 100 years and the product is already proven to be bio-equivelant...It is a generic drug and the Naltrexone is shown not to leak, passed the HAL studies, and is solid on stability.

The FDA does not require and we file immediately.

Either way under expedited review.

" A cynic is a man who knows the price of everything and the value of nothing". - Oscar Wilde

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