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Friday, December 14, 2018 5:43:07 PM
"Any agreements reached during the meeting will be recorded in the FDA meeting minutes and provided to the sponsor."
The timeline and the protocols as I remember them do require that a copy of the minutes of the meeting is to be provided to IPIX within 30 days of the meeting, but the timeline language says "Meeting minutes and responses sent to PI" at that 30 day point.
I take it that the responses refer to FDA answers to the questions IPIX raised in the meeting package.
The timeline seems to me to have a certain finality to it. Agreements are expected to be reached, FDA responses to IPIX questions provided. Thirty days later it will all be documented. I get the sense that the outcome will be a take it or leave it proposition. As in the case of the SPA IPIX will come away from the meeting needing to decide whether to go forward or not, knowing that the FDA has certain expectations based on the agreements made at the meeting.
1. Is there any reason to think that the FDA will develop and provide new issues during the 30 day "waiting period" or will IPIX know everything there is to know about the FDA's expectations at the end of the meeting?
2. My recollection is that there will not be a second EOP2 meeting. Is that your understanding?
3. In other words, am I right in believing that there will be no opportunity for any post-EOP2 haggling?
But can it core A apple?
Yes Ralph, of course it can core A apple.
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