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Re: dr_lowenstein post# 131223

Monday, 10/20/2014 5:09:55 PM

Monday, October 20, 2014 5:09:55 PM

Post# of 404583
OK, so they need efficacy data, which (since they are going the 505b2 route) they could get from the comparator drugs trial results?

They don't necessarily have to run a specific efficacy trial of their own unless the FDA feels that is necessary... correct?

So I guess we will see what comes out of Elite's meeting with the FDA.

Either way it's just a matter of time.

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