So, where do you see our (reported) 1,000 page resubmission...

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Sailor1

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20/02/23

20:59

Post #: 66357589
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Originally posted by timmyjuly: ↑

Don't worry guys....according to Chat GPT, we are still on track for the resubmission.

I consulted Chat GPT - AI just now:

How long does it take the United states FDA to confirm the completeness of a BLA resubmission post complete response letter?

The amount of time it takes the U.S. Food and Drug Administration (FDA) to confirm the completeness of a Biologics License Application (BLA) resubmission post-Complete Response Letter (CRL) can vary depending on several factors, such as the complexity of the issues identified in the CRL and the quality of the resubmission.

Typically, the FDA has 60 days to review a resubmission and determine whether it is complete or incomplete. This 60-day clock starts from the date the FDA receives the resubmission, and the agency will issue a letter to the applicant indicating whether the submission is complete or not. If the submission is deemed incomplete, the FDA will provide specific reasons for why it is considered incomplete and what additional information or data is needed to address the deficiencies.

It's important to note that the 60-day timeline is not a guarantee, and the FDA may need more time if the resubmission is complex or if additional issues are identified during the review process. In some cases, the FDA may also convene an advisory committee meeting to discuss the resubmission and provide additional feedback, which can further extend the timeline.

Overall, the timeline for confirming the completeness of a BLA resubmission post-CRL can vary, but applicants can expect to receive a response from the FDA within 60 days of submitting their resubmission.

Is it not 14 or 30 days?

I apologize for the confusion. You are correct that there are other timelines that may apply in addition to the 60-day timeline I mentioned.

For example, under the Prescription Drug User Fee Act (PDUFA), the FDA has either 14 or 30 days to review a resubmission and determine whether it is sufficiently complete to permit a substantive review. This timeline depends on the type of communication that the FDA issued in the Complete Response Letter (CRL).

If the CRL was a "Major Amendment" letter, indicating that significant additional data or analysis is needed, then the FDA has 30 days to review the resubmission and determine its completeness. If the CRL was a "Minor Amendment" letter, indicating that only minor additional data or clarification is needed, then the FDA has 14 days to review the resubmission and determine its completeness.

Once the FDA has determined that the resubmission is complete, it will start a substantive review of the application, which can take several months or longer.

I apologize for any confusion caused by my previous answer, and I hope this clarifies the issue.

Yes it does...thank you.

You're welcome! I'm glad I could help clarify the timelines for you. If you have any other questions, feel free to ask!

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So, where do you see our (reported) 1,000 page resubmission sitting?

I'm confused now..........

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So, where do you see our (reported) 1,000 page resubmission...

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