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Posted On: 11/26/2018 7:30:09 PM
Post# of 72440
The following was posted on another site and as I read it, it says that the FDA will have minutes ready within 30 calendar days after the meeting.
Not sure how this affects IPIX, can they discuss mtg prior to the official minutes getting published? IMO, don't see why not, since minutes are strictly for FDA use making sure results are correct for future reference.
If it does mean IPIX can't discuss prior to that, then we have more waiting to do.
Not sure where the below came from, maybe Dauber knows, but makes me think IPIX may have a 30 day muzzle on them after the mtg. But then, maybe they are only talking about the official minutes and company can discuss mtg prior without such talk being official.
"The minutes of the meeting will be made available by the FDA within 30 days of the meeting and the Company will be free to share them with any interested parties at that point"
See pp14-15 of https://www.fda.gov/downloads/Drugs/.../Guida...590547.pdf
"MEETING MINUTES
Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
information is preserved for meeting attendees and future reference. The FDA will issue the
official, finalized minutes to the requester within 30 calendar days after the meeting"
etc.
Not sure how this affects IPIX, can they discuss mtg prior to the official minutes getting published? IMO, don't see why not, since minutes are strictly for FDA use making sure results are correct for future reference.
If it does mean IPIX can't discuss prior to that, then we have more waiting to do.
Not sure where the below came from, maybe Dauber knows, but makes me think IPIX may have a 30 day muzzle on them after the mtg. But then, maybe they are only talking about the official minutes and company can discuss mtg prior without such talk being official.
"The minutes of the meeting will be made available by the FDA within 30 days of the meeting and the Company will be free to share them with any interested parties at that point"
See pp14-15 of https://www.fda.gov/downloads/Drugs/.../Guida...590547.pdf
"MEETING MINUTES
Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
information is preserved for meeting attendees and future reference. The FDA will issue the
official, finalized minutes to the requester within 30 calendar days after the meeting"
etc.
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