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Re: mtsugawa post# 21029

Friday, 10/24/2014 8:14:21 PM

Friday, October 24, 2014 8:14:21 PM

Post# of 30990
It's hard to spin this closeout letter as a big deal, but after looking at 5 or 6 websites on the topic, it does look like it is a necessary step that precedes anything else the FDA does. So now maybe with compliance acknowledged, the way is clear for RCPI to progress in the IND process.

The fact that at least two websites had to do with webinars and/or audio material on the FDA warning letter and closeout process does seem to suggest how complicated this is.

Anyway, it's more of a good thing than a bad one!

Was not anyone else surprised at the mention of Gulf War illness as one of the topics at the meeting in mid-November?

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