Record of Email Receipt, September 16, 2011 - MenHibrix
From: David C. Staten, Jr., MPH
FDA Participants: N/A
Non-FDA Participates: N/A
Received the following email from sponsor;
• We have discovered a minor error in the Summary of Clinical Efficacy in the BLA. As a result of a cut‐and‐paste error, in Appendix Table 4 of m 2.7.3 the anti‐PSY values for study Hib‐ MenCY‐TT‐006 are incorrect. All other data in the table (studies 008 and 010) are correct. Note that the data are not from a primary analysis and that the correct 006 data can be found in the Clinical Study Report (CSR) for ‐006 (Table 26) in m18.104.22.168 of the BLA. At this point, I propose not to update the Summary, since the correct data are available in the CSR.
ACTION: Discussed this issue with the MO. This error will not effect the clinical review or the outcome of the decision to issue an additional CR