Elite Pharmaceuticals Inc (ELTP): What I really interesting is now that th...

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Elite Pharmaceuticals Inc (ELTP)

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Re: A deleted message

Friday, 01/15/2016 6:30:56 AM

Friday, January 15, 2016 6:30:56 AM

What I really interesting is now that the NDA application was accepted and approved so that Elite could submit the filing... FDA gives a 6 week to 12 week REVIEW of the filing to see if there is anything Elite needs to do further.
So confident with Camargos help everything will go smooth. Those 505 b 2s are Camargos bread and butter.

But one thing strikes me as odd.. why such an opened window for the review? Up to 12 weeks for a review the FDA should already be well versed on.
Did Elite not file an IND for ELI-200 with the FDA? I believe they did.... didnt they.

Lots of things one could do in a 12 week period after thorough review of what they have already been versed on.

Wonder how long till approval of ELI-200?

smile

smile

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