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Re: sts66 post# 29749

Tuesday, 06/24/2014 4:57:37 PM

Tuesday, June 24, 2014 4:57:37 PM

Post# of 426504
sts66 (and chas1232123),

Do not get me wrong: I do not say FDA played an open, cooperative role. Their action against any real, valid logic.

FDA definitely not breached the guidance, however I analyzed again the guidance and have to say ‘salute’ … It's not confusing, it's tricky ...

“If the materials do not contain information that, under certain circumstances, could be considered to be confidential commercial or trade secret information belonging to a sponsor, the portions of the timelines (see Appendices) that pertain to sharing our briefing materials with sponsors will not apply.“
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