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Posted On: 08/19/2022 4:43:39 PM
Post# of 145909
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Re: Evil Rabbit #127861
Waiting is worse than watching paint dry. I keep thinking about the reason for the safety hold; that our CRO failed to document the safety data. Then we learned the safety data was there, but in the wrong format. Then, the new CRO had to attempt to re-format the data in an acceptable form for FDA. So, I feel this is a bureaucracy acting like a bureaucracy. Check the box, fill out the forms. Don't matter what other data is available. Needs to be in an acceptable form. Of course, it could be exacerbated by getting slow walked just to let us know who's in charge.
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