Cell Therapy News/Articles, page-16618

Speaking of Rules and Guidances for the FDA to follow. You seem to regularly gloss over them. Just incase you missed it last time.

Also a repost with links:

The SOPs aren't an opinion.

"Which is tantamount to saying that in your opinion since they accepted the resubmitted BLA then approval will be automatic."

Only if you're not able not think critically. No one has suggested it will be "automatic". Your "opinion" relies too much on misinterpreting language. And from what we have learned from your posts is that this is no accident on your part.

If you prefer I'll use the exact language from the SOP.

The FDA (the regulatory Project manager and the review Committee) has determined the resubmission is a complete response through a cursory review. Adequacy of the response will be determined through the review process.


Incase you didn't bother reading it the last time it was shared here:

SOPP 8405.1: Procedures for Resubmissions to an Application or SupplementVersion: 8Effective Date: November 13, 2022

VI Responsibilities

A. Regulatory Project Manager (RPM)

3. Determine initially whether the submission is a complete response if the applicant indicates a complete response for a biosimilar biological product submission, non-user fee submission or any non-efficacy supplement.

B. Review Committee Member

1. Determine whether the resubmission contains responses to all deficiencies in the CR letterVII. Procedures
A. Perform cursory review of the resubmission to determine if it is a proposed complete response or incomplete response to a CR letter. [RPM]

B. Ensure data for all submissions is entered in the appropriate regulatory system, including assignment of third level STN if appropriate. [RPM] Note: if the applicant designates the submission as a complete response, the review clock is started.

C. Notify the review committee of receipt of a resubmission and forward to appropriate review committee members. [RPM]

D. Confer with review committee to make certain the response for a resubmission is complete. [RPM]

E. Determine if a resubmission is a complete or an incomplete response. [Review Committee Members] Note: The resubmission will be considered complete if the applicant responds to each question or issue in the CR letter. If the resubmission is determined to be complete, the adequacy of the response will be evaluated during the review.