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Re: DewDiligence post# 105359

Wednesday, 09/29/2010 2:05:13 PM

Wednesday, September 29, 2010 2:05:13 PM

Post# of 257257

There have been myriad cases where the FDA inspected an applicant’s plants and ended up not approving the drug in question on the current review cycle.



IF TRUE, that largely negates the assertion that FDA would not bother to inspect unless they were nearing approval and the inference of near-term approval.

ij

PS, The "if" statement is not an indication of non-belief. Like Schultz, "I know nothing, nothing ..."

PSS - Thanks RockRat.

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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