Dates communicating with the FDA regarding BLA sub
Post# of 153822
(Total Views: 1129)
Posted On: 10/27/2021 3:16:13 PM
Dates communicating with the FDA regarding BLA submission begins... January 22, 2019...June 3rd, 2019...November 11th, 2019...December 19th, 2019...
The RTF summary contends that "No information is provided in the Section" Adverse Effects leading to drug Interruption...THIS stood out to me...of all the things not to report is our strongest and most valuable suit...SAFETY. The rest as follows:
1. ABSENCE of Bioanalytical Reports
2. INCOMPLETE "Overview of Clinical Pharmacology" section.
3. INCOMPLETE Summary of Clinical Pharmacology Studies
4. Submission of UNAGREED Upon Population PK (pop PK) analysis.
5. MISSING CCR5 Receptor Occupancy Data.
6. Electronic Dataset Quality ISSUES
7. Critical elements in Statistical Datasets are MISSING.
8. INCOMPLETE start and/or end date information for AE's.
9. Toxicity grading is MISSING from laboratory datasets.
10. Critical elements in the Virology Resistance datasets are MISSING.
11. ABSENCE of Demographic Subset Analysis.
12. Device-related ISSUES (syringes).
13. SAFETY data INCOMPLETE.
14. Human factors related ISSUES.
15. product QUALITY-related ISSUES.
16.Exclusivity clauses ISSUES
17. Financial disclosure information ISSUES.
18. Proposed Proprietary NAME ISSUES.
This will be the second time I have posted this comment "IF their intentions were unintentional...the result was the same...OUR lawyers should have a Field day with this FDA statement...NSF are probably rethinking their acquisition of Amarex... in retrospect.
The RTF summary contends that "No information is provided in the Section" Adverse Effects leading to drug Interruption...THIS stood out to me...of all the things not to report is our strongest and most valuable suit...SAFETY. The rest as follows:
1. ABSENCE of Bioanalytical Reports
2. INCOMPLETE "Overview of Clinical Pharmacology" section.
3. INCOMPLETE Summary of Clinical Pharmacology Studies
4. Submission of UNAGREED Upon Population PK (pop PK) analysis.
5. MISSING CCR5 Receptor Occupancy Data.
6. Electronic Dataset Quality ISSUES
7. Critical elements in Statistical Datasets are MISSING.
8. INCOMPLETE start and/or end date information for AE's.
9. Toxicity grading is MISSING from laboratory datasets.
10. Critical elements in the Virology Resistance datasets are MISSING.
11. ABSENCE of Demographic Subset Analysis.
12. Device-related ISSUES (syringes).
13. SAFETY data INCOMPLETE.
14. Human factors related ISSUES.
15. product QUALITY-related ISSUES.
16.Exclusivity clauses ISSUES
17. Financial disclosure information ISSUES.
18. Proposed Proprietary NAME ISSUES.
This will be the second time I have posted this comment "IF their intentions were unintentional...the result was the same...OUR lawyers should have a Field day with this FDA statement...NSF are probably rethinking their acquisition of Amarex... in retrospect.
(16)
(0)