Replies to post #347051 on Anavex Life Sciences Corp (AVXL)

[end2war]

What is rolling review FDA?

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.Jan 4, 2018

Rolling Review is only available for certain FAST Track or BTD indications and the Rett's application would qualify, I believe.

Challenges and risks to rolling submissions
There are multiple challenges and risks associated with rolling submissions compared with standard submissions.

You must get the FDA’s agreement before moving forward with a rolling submission. Once that agreement is obtained, you must adhere to the agreed timelines.
Draft documents should not be submitted, and each rolling submission part should be complete and reviewable as submitted.
A rolling submission multiplies the complexity of the application, with more deadlines, decisions, and document locations to be tracked.
You must prepare and submit responses to Information Requests while still developing the other parts of the submission.
Overall, it is necessary to have an experienced submission manager to help align all the necessary pieces for each part of the submission and to keep the timelines in sync.

https://www.certara.com/blog/rolling-nda-and-bla-submissions-accelerate-your-timeline-for-review/#:~:text=First%2C%20the%20FDA%20must%20agree,the%20timeline%20and%20submission%20parts.

Check the appendex to this document for full details:

https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf