IND : (b)(4)
Date: February 9, 2011
Initiated By: FDA
Author: David C. Staten, Jr., MPH
Refer to GSK January 28, 2011 submission to IND (b)(4) (amendment 73).
In this amendment GSK stated,
“During the teleconference between CBER and GSK held November 19, 2010 this rationale was discussed and CBER agreed that it would be acceptable for GSK to submit all information regarding the serology assays to the MenACWY-TT IND and request an End of Phase 2 Meeting at some point in the future, and thus delink the review and progression of MenACWY-TT from that of MenHibrix. GSK plans to file a second Request for a Type B End of Phase 2 Meeting for MenACWY-TT in the near future”
In the November 19 th telecon minutes these is no mention of this discussion or any agreements made by CBER for “delinking” the reviews or to hold a EOP2 meeting. This was conveyed to the sponsor.
CBER agreed during the November 19 th telecon to accept additional data that relates to free PS testing which will be submitted to IND (b)(4). CBER also agreed to review these data in 60 days or less. GSK will also submit additional data on the proposed alternative method, -------------(b)(4)-------------. CBER has received these data and conveyed to the sponsor that the review will be completed by the end of the month. Additional data from pending -(b)(4)- experiments will also be submitted in a follow-up submission.
GSK stated that without this separation they fear the development of the quadravalent product would be effected. CBER stated that reviews must stay coupled since they are the exact same products in the two files.
GSK asked if CBER’s decision to keep the reviews coupled was due to resources. CBER responded that there are resources issues as well as technical issues, i.e., technical issues relating to using the same assays with different sources.
GSK requested that CBER review priorities remain with the BLA. Back in June serology assay data was submitted to the BLA including a response to the serology comment in CBER’s CR letter. CBER is currently reviewing these data.
CBER stated that the issue concerning free PS with MenHibrix still remains unresolved.
Further discussion with the sponsor concerning the review of additional data is expected by the end of the month.