
Filing Memo Reminder, February 8, 2012 am - Octaplas

 
 
 

From:                    Frost, Mitchell M

Sent:                      Wednesday, February 08, 2012 11:16 AM

To:                         Rana, Pratibha

Cc:                         Kirschbaum, Nancy; Jain, Nisha

Subject:                 FW: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

 

 

______________________________________________

From:                    Frost, Mitchell M 

Sent:                      Wednesday, February 08, 2012 11:12 AM

To:                         Rana, Pratibha

Cc:                         Kirschbaum, Nancy

Subject:                 RE: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

 

Hi Pratibha,

 

From the clinical perspective, I do not find any deficiencies in the submission that would prevent filing.

 

Thanks,

Mitch

 

_____________________________________________

From:                    Rana, Pratibha 

Sent:                      Wednesday, February 08, 2012 11:06 AM

To:                         Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)

Subject:                 Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

 

Hello All,

This is a reminder to upload your signed off Filing memo by Friday February 10, 2012.

If you are writing a filing memo as email please CC me and the chairperson, Nancy Kirshbaum.

Thanks

Pratibha

 

_____________________________________________

From:                    Rana, Pratibha 

Sent:                      Thursday, January 05, 2012 1:38 PM

To:                         Rana, Pratibha; Rana, Pratibha; Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)

Subject:                 Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

When:                    Tuesday, February 07, 2012 1:00 PM-2:00 PM (GMT-05:00) Eastern Time (US & Canada).

Where:                  CBER Conf. WOC-400S

 

( if you are unable to attend in person and by phone) please send an email answering the following topics to SL, Nancy Kirshbaum and me).

 

STN 125416/0

Product: Pooled Plasma, Solvent Detergent Treated (Human)

Sponsor: Octapharma

 

Filing Meeting:

To determine if this BLA is fileable/RTF/Deficiencies 

Decision on priority review or not

 

 

Call in info for those who cannot attend in person:

 

----(b)(4)-------

Participant code: --(b)(4)---

 

Thanks

Pratibha