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DewDiligence

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DewDiligence

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Re: iwfal post# 107362

Thursday, 10/28/2010 10:03:47 AM

Thursday, October 28, 2010 10:03:47 AM

Post# of 257253

…if they are that different then why hasn't the FDA rejected it outright?

For the reason that was previously discussed on this board: the FDA very rarely issues a formal rejection of an ANDA.

Note: the FDA has not even formally rejected the Lovenox ANDA from Amphastar despite the fact that Amphastar’s public actions reveal the ANDA to be hopeless.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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