
Record of Telephone Conversation, June 9, 2009 - Flublok


Submission Type: Original Application   Submission ID:  125285/0   Office: OVRR  

 

Product:

Influenza Vaccine

 

Applicant:                                                                        

Protein Sciences Corporation          

 

Telecon Date/Time:  09-JUN-2009 12:54 PM              Initiated by FDA?  Yes

Telephone Number:    

 

Communication Categorie(s):

Information Request

 

Author:  TIMOTHY FRITZ

 

Telecon Summary:

Request for SAS programs used to analyze studies PSC04 and PSC06 to be submitted as an amendment to STN 125285

 

FDA Participants:   Timothy Fritz

 

Non-FDA Participants:    Penny Post

 

Trans-BLA Group: No

 

    

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:

 

Hi Penny-

 

In response to your June 8, 2009 emails to Rakesh Pandey, please submit the SAS programs used for the analysis of studies PSC04 and PSC06 on a single CD as an amendment to STN 125285.

 

Please organize the CD to contain two folders. One should be labeled "SAS programs PSC04" and the second should be labeled "SAS programs PSC06". Please place the corresponding SAS programs in the appropriate folder.

 

If you have any questions, please contact me a 301-827-3070.

 

Thanks,

Tim Fritz

 

Timothy A. Fritz, Ph.D.

Microbiologist

FDA/CBER/OVRR/DVRPA/RRB2

WOC1 HFM-478 Suite 371N

1401 Rockville Pike

Rockville, MD 20852

Phone: 301-827-3070

Fax: 301-827-1597

 

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.