
Filing Meeting Email, February 7, 2012 - Octaplas

 

 
 

From:                    Peng, Ze

Sent:                      Tuesday, February 07, 2012 3:24 PM

To:                         Rana, Pratibha; Kirschbaum, Nancy

Cc:                         Lee, Timothy

Subject:                 RE: Filing Meeting/STN 125416/0/OctaplastLG from Octapharma

 

Good afternoon, Pratibha and Nancy:

 

Regarding the original BLA under STN 125416 submitted by Octapharma for Solvent/Detergent treatment human plasma, OctaplasLG, I did a preliminary review on two sections, Stability (3.2.S.7 and 3.2.P.8) and Adventitious Agents Safety Evaluation (3.2.A.2). I found that the information provided in these sections will allow me to perform a meaningful review. Therefore, this submission can be filed.

 

Thanks

 

Ze