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Re: zipjet post# 107845

Tuesday, 11/02/2010 2:24:57 PM

Tuesday, November 02, 2010 2:24:57 PM

Post# of 257253

IF you mean, that you do not think FDA is going to tell an applicant that "yes you have established sameness" then I agree with that. It offers too much legal risk to go making pronouncements before the final decision. Clerks do not need that.

(my emphasis above)

Yes, but remember, TEVA said they spoke to management!

So there! >rolls eyes<

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