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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Mid-cycle communication telecon, January 08, 2013 - Novoeight

From: CDCA (Cindy Cao) [cdca@novonordisk.com]
Sent: Tuesday, January 08, 2013 1:55 PM
To: Pracht, Leigh
Subject: RE: Mid-cycle communication telecon (PDUFA V): STN 125466/0__NOVO NORDISK INC.__Original BLA__Antihemophilic Factor (Recombinant) __ADD: 15-Oct-13

Attachments: emfinfo.txt; emfinfo.txt

Dear Leigh,

 Thank you very much for your quick response. Yes, I think April 17 at 10 am works for the T-con.

Best,

Cindy

 --------------------------------------------------------------------------------

From: Pracht, Leigh [mailto:Leigh.Pracht@fda.hhs.gov]
Sent: Tuesday, January 08, 2013 1:47 PM
To: CDCA (Cindy Cao)
Subject: RE: Mid-cycle communication telecon (PDUFA V): STN 125466/0__NOVO NORDISK INC.__Original BLA__Antihemophilic Factor (Recombinant) __ADD: 15-Oct-13

 Cindy,

 Would Wednesday, 17-Apr-13, at 10 am be feasible?

 Thanks,

Leigh


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From: CDCA (Cindy Cao) [mailto:cdca@novonordisk.com]
Sent: Tuesday, January 08, 2013 1:39 PM
To: Pracht, Leigh
Subject: RE: Mid-cycle communication telecon (PDUFA V): STN 125466/0__NOVO NORDISK INC.__Original BLA__Antihemophilic Factor (Recombinant) __ADD: 15-Oct-13

 Dear Leigh,

 Thank you very much for your effort in scheduling this now. Since many of our T-con attendees will be in Denmark where the time zone is 6 hrs earlier than EST, I wonder if it is possible to have a slot in the morning in the week of April 15? I know it is not easy for you to get all FDA attendees at the same time slot---just ask as a possibility.

 Many thanks,

Cindy

 --------------------------------------------------------------------------------

From: Pracht, Leigh [mailto:Leigh.Pracht@fda.hhs.gov]
Sent: Tuesday, January 08, 2013 12:30 PM
To: CDCA (Cindy Cao)
Subject: Mid-cycle communication telecon (PDUFA V): STN 125466/0__NOVO NORDISK INC.__Original BLA__Antihemophilic Factor (Recombinant) __ADD: 15-Oct-13

 Cindy,

 As time tends to get away from us, I thought now might be a good time to schedule the mid-cycle telecon with you.  I am tentatively looking at Tuesday, April 16, 2013 from 1:30-2:30 pm.  Would you please check this date for Novo Nordisk’s availability?

 Thank you,

 Leigh A. Pracht

Regulatory Project Manager

FDA/CBER/OBRR/DBA

WOC1; RM 572N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116

Fax: 301- 827-2857

Leigh.Pracht@fda.hhs.gov