Record of Telephone Conversation - Cervarix, August 9, 2007

Record of Telephone Conversation

 

 

To:             File

From:         Helen S. Gemignani, Regulatory Project Manager  

Subject:      MPL Safety Analysis Plan Discussion

Telecon Date:  August 9, 2007     Telecon Time:   09:00 - 10:00 am

Telecon Initiated by: GSK

Contact Phone: 610 787-3726 Mr. Whitman

 

Signature:                                                                                

 

Summary of Telecon

As per the July 18, 2007 and August 6, 2007 telecons between GSK and CBER, GSK submitted, to CBER, a document (attached) outlining the proposed timing of the MPL safety analysis submission.  This safety analysis plan was the subject of this telecon.

CBER found acceptable the list of variables to be used in the proposed analytical approach.  CBER reiterated that an integrated pooled analysis is not what was requested but rather a true meta-analysis.  GSK understood and will comply with CBER’s request for a true meta-analysis.

Dr. Raychaudhuri suggested that this type of discussion is considered a high priority, that a separate telecon be arranged, between GSK and CBER, to discuss the specific aspects of the statistical review.  It was agreed to hold this telecon within an hour following the current discussion.

Dr. Raychaudhuri asked how much data is expected to be submitted in the August 27, 2007, submission.  Dr. Dubin replied that 80% of all subjects enrolled in studies containing MPL will be included in this submission.

Dr. Sutkowski pointed out that CBER/OCTGT IND -b(4)- was omitted from the Table attached to the briefing document.  GSK replied that this was an oversight and that information from IND -b(4)- will be submitted to OVRR in the safety analysis submissions.

The next subject of the briefing document (attached) pertained to proposed revised language to Investigator Brochures and Informed Consent forms to reflect suspected neuroinflammatory conditions and potential autoimmune adverse events.  Dr. Miller suggested the IB have more specific language in regard to transverse myelitis.  GSK proposed that this may be a temporary event and perhaps that language can be placed elsewhere.  CBER suggested they expound on neuroinflammatory conditions and to provide more examples.  GSK will re-work the language and provide the new language to CBER by cob today.  The IC language was acceptable to CBER.

CBER inquired whether Corixa had any studies that were not done/are not being done under IND.  GSK stated that they are looking into everything.

Dr. Martha Lee asked about the 80% data being submitted on August 27 and if the data lock point is June 2007.  GSK concurred that June 30, 2007, is the data lock point with the exception of HPV-009.  The DLP for that NCI study was March 30, 2007, and any further data from that study would have to come from NCI.

End of Teleconference

Action Items

• GSK will perform a true meta-analysis and submit to CBER by August 27, 2007.
• GSK will re-work the Investigator Brochure language and provide the revised language to CBER by COB today.
• A telecon will be held between CBER and GSK today to discuss the statistical issues of the safety analysis plan.

FDA Participants

• Florence Houn

• Gopa Raychaudhuri

• Nancy Miller
• Martha Lee
• Elizabeth Sutkowski
• Helen Gemignani

GSK Participants

• Amy Scott
• Vince Ahonkai
• Matt Whitman
• Gary Dubin
• Harry Seifert
• Marguerite Deschamps
• Brigitte Cheuvart
• Fabian Tibaldi
• Marie-Pierre David