From memory ( and I could be wrong) at the start of the trials the FDA did have questions for us and when they were asked PAR explained the process of how they had to go through the question, process a reply then send it to the FDA. The FDA then have another 30 days to accept it or to ask further questions or clarification and the 30 + day cycle starts over again. Therefore the need to be precise was paramount to avoid a long drawn out submission.
If I am incorrect, I apologise and would appreciate a correction.
Voddy
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From memory ( and I could be wrong) at the start of the trials...
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