Anavex Life Sciences Corp (AVXL)

[Steady_T]

I guess if you think the filing should happen within 45 days of the receipt of data then the filing is delayed.

Determining Timelines
Once you have determined your key stakeholders, you will want to determine timelines to ensure steady progress continues to be made on the document. If you’ve chosen to utilize a scope document, you’ll want to include these timelines in it, so the entire team is aware of the project process, the timing requirements, and each gating item (key gating items are summarized in Figure 1).



Figure 1: Preparing, Writing, and Review of the Clinical Study Report—Key Gating Items

Preparation of Data Writing and Document Review
o Data cleaning and query resolution o Write non-results sections
o Plan tables, listings, and figures (TLFs) o Perform literature review
o TLF creation and revisions o Write results sections
o TLF editing o Cross team/stakeholder review
o Data-lock process o Incorporation of revisions
o Final TLF preparation o Finalize report for submission


Time management is paramount for clinical trial submissions to regulatory authorities. Attendees at medical writing conferences over the course of a five-year period (2008 to 2013, n=78) were surveyed to determine to how long each step of the CSR process can typically require.{8}

To complete a “moderately complex” CSR for a Phase III study with 200 to 400 participants, the surveyed medical writers responded with a mean answer of 16.9 days from the receipt of the final tables, listings, and figures (TLFs) to delivery of the first draft of the CSR. They estimated a mean of 25.7 days from the first draft to the final draft routed for review. The time from database lock to completion was reported to be on average 83 days.

https://acrpnet.org/2020/09/15/clinical-study-reports-101-tips-and-tricks-for-the-novice/