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exwannabe

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exwannabe

Re: zipjet post# 55711

Wednesday, 12/05/2007 9:41:52 PM

Wednesday, December 05, 2007 9:41:52 PM

Post# of 252672
zip, if a company is challanging the SPA interpretation...

The company has the ability to publish the SPA, but they almost never do.

The FDA can not disclose this, so we have a very one sided public debate in these situations (ENCY for example).

If ENCY or others expect to convince the public that these are problems with FDA "wiggle room", then just publish the SPA.

But they don't, because I suspect it is the company that is attempting to "wiggle".
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