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

 
 

Response to information request for Bioclon meetingFrom: ------(b)(4)-------- 
-----(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)---
 
---(b)(4)---
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--------(b)(4)--------
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phone: ---(b)(4)---
fax: ---(b)(4)---
email:  ---(b)(4)---
 
 


 

From: Cordaro, Debbie [mailto:Debbie.Cordaro@fda.hhs.gov] 
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  
Debbie Cordaro 
Debbie Cordaro 
Regulatory Project Manager 
OBRR 
Voice: 301-827-6157 Fax 301-827-2857 
debbie.cordaro@fda.hhs.gov
