Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Response to Information Request Email, February 17, 2010, Anascorp

Response to information request for Bioclon meetingFrom: ------(b)(4)--------
Sent: Wednesday, February 17, 2010 7:08 PM
To: Cordaro, Debbie
Cc: -------------------(b)(4)------------------------
Subject: Anascorp IR Jan 21, 2010 Response - Bioclon

Hello Debbie,
Please accept my apologies for the delay in contacting you.  We do want to have
a teleconference to discuss the points in the correspondence dated January 21,
2010.  A response will be submitted on or before February 25, 2010.
Let me know if this timeline is acceptable.
Thank you,
(b)(4) for ---(b)(4)---
phone: ---(b)(4)---
fax: ---(b)(4)---
email:  ---(b)(4)---


From: Cordaro, Debbie []
Sent: Wednesday, February 17, 2010 11:21 AM
To: ---(b)(4)---
Cc: ---(b)(4)---
Subject: Response to information request for Bioclon meeting

Hi (b)(4),
In regard to the meeting we were to have had in January, your second CMC meeting
for the CR letter for STN 125335/0, I  am following up on our request for
additional information.  We sent you the proposed responses with a request for
information almost 4 weeks ago. We did not expect this much time would elapse
before receiving your follow-up information, so unless you can respond in a day
or two, I think we need to consider the January meeting cancelled, and ask that
you submit a new meeting request to address these issues.

Please let me know your timeline for responding,
Debbie Cordaro
Debbie Cordaro
Regulatory Project Manager
Voice: 301-827-6157 Fax 301-827-2857

Page Last Updated: 01/28/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English