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Vaccines, Blood & Biologics

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Request to Cancel Meeting Email, February 17, 2010 - Anascorp

Response to information request for Bioclon meeting

From: ------(b)(4)-------
-----(b)(4)-----
Sent: Thursday, February 25, 2010 12:50 PM
To: Cordaro, Debbie
Cc: --------------------(b)(4)------------------------
Subject: RE: Anascorp IR Jan 21, 2010 Response - Bioclon

Hi Debbie:
After consultation with Bioclon, it appears we are not yet ready with our final
documents. At this time it looks like we may not have them truly finalized until
about mid-March, thus we will not be able to meet our previous commitment. 
Thus, please consider the January meeting cancelled and we will, if needed,
request a new meeting with the Agency.
 
Thanks for your patience and understanding.
(b)(4)
 
---------(b)(4)---------
--(b)(4)--
-----(b)(4)-----
-----(b)(4)-----
------(b)(4)------
(P) ----(b)(4)----
(F) ----(b)(4)----
 



From: -----(b)(4)----- [mailto:----(b)(4)----]
Sent: Wednesday, February 17, 2010 4:08 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)----
------(b)(4)------
---------(b)(4)---------
------(b)(4)------
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


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