We all expect the minutes of meeting from FDA within the next 2 weeks. Don't get disappointed when you don't hear anything from the company within the next 2 weeks (or before 19th of May)...If you understand their process here:
The following are general considerations regarding meeting minutes:==> So, perhaps ANP had already received the feedback from FDA? But...something need for further clarification?? In that case:
- FDA minutes will outline the important agreements, disagreements, issues for further discussion, and action items from the meeting in bulleted format. This information does not need to be in great detail. The minutes are not intended to represent a transcript of the meeting.
- FDA project managers will use established templates to ensure that all important meeting information is captured.
- The FDA may communicate additional information in the final minutes that was not explicitly communicated during the meeting (e.g., pediatric requirements, data standards, abuse liability potential) or that provides further explanation of discussion topics. The FDA’s final minutes will distinguish this additional information from the discussion that occurred during the meeting.
The following steps should be taken when there is a difference of understanding regarding the minutes:
- Requesters should contact the FDA project manager if there is a significant difference in their and the FDA’s understanding of the content of the final meeting minutes issued to the requesters
- If after contacting the FDA project manager there are still significant differences in the understanding of the content, the requester should submit a description of the specific disagreements either: -To the application; or If there is no application, in a letter to the division director, with a copy to the FDA project manager
‒ If the minutes are deemed to accurately and sufficiently reflect the meeting discussion, the FDA project manager will convey this decision to the requester and the minutes will stand as theofficial documentation of the meeting.
- The review division and the office director, if the office director was present at the meeting, will take the concerns under consideration
‒ If the FDA deems it necessary, changes will be documented in an addendum to the official minutes. The addendum will also document any remaining requester objections, if any.
From the above, I believe why the company stated in the announcement:
"The Company expects to provide further details following receipt from the FDA of the official minutes of the meeting in late May 2021. "
Anyway, I'm more eagerly anticipate the feedback on PIP!! That's the most crucial part in order for ANP to moving forward...Once we get the green light from PIP, I believe FDA will follow suit.. let's hope so.
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- Ann: US FDA Type C Meeting for ATL1102 in DMD
Ann: US FDA Type C Meeting for ATL1102 in DMD, page-81
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