Avid Bioservices Inc (CDMO)

[nuke661]

Ex,

Correct me please if I'm wrong but I believe because we have Fast Track that we have the ability for rolling review and with rolling review the FDA can make a decision for priority review based on the preliminary data submitted as part of the rolling review without having to wait for the regular package submission:

2. Submission of Portions of an Application (Rolling Review)
If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application (see Appendix 2).10

This was obtained from the following document:

Expedited Programs for Serious Conditions – Drugs and Biologics

Update: after thinking about this some more I believe that I was was wrong believing the preliminary rolling review data leads to a priority review. However, I believe it is even better because if the rolling review data is sufficiently compelling the FDA will start the review process before having to wait for the complete application package submittal. This certainly seems to be even faster than priority review which can't start until after complete application package submittal. Again, that's if I understand the document correctly.