Elite Pharmaceuticals Inc (ELTP): Lasers, is this correct: at 60 days from...

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Elite Pharmaceuticals Inc (ELTP)

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Re: ARbigguy1 post# 185802

Tuesday, 02/23/2016 10:16:06 AM

Tuesday, February 23, 2016 10:16:06 AM

Lasers, is this correct: at 60 days from filing (which would be March 14th or 15th, 2016 for ELTP’s filing) FDA does *not* contact the company to acknowledge acceptance of filing—at 60 days, FDA would contact the company *only* if there was something about the filing that was not complete.

If FDA is happy with the filing and ready to review it in depth, they will not say anything until the 74 day letter (which would be no later than March 28th or 29th, 2016 for ELTP).

Therefore, ELTP should not expect to hear from the FDA until the 74 day letter arrives on or before March 28th or 29th, 2016.

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