`-Please file with BG12 MS IND.
`
`26-Jul-2005 03:13 PM
`
`Message Size: 6.9 KB
`
`cc
`
`bee
`
`Subject Fw: PIND 73,061 BG00012 Meeting Request
`
`"Wheeloua, T ereaa A •
`<WHEELOUST@cder .fda.gov
`>
`07/26/2005 03:09PM
`
`To
`
`cc
`
`Subject PIND 73,061 BG00012 Meeting Request
`
`• Please refer to your conespondence dated July 8, 2005 and received July 11, 2005, requesting a
`
`type B Pre-IND meeting.
`
`Based on the statement of purpose, objectives, and proposed agenda, we consider the meeting a
`type B meeting as described in our guidance for indusiiy titled Formal Meetings with Sponsors
`and Applicants for PDUFA Products (Febmary 2000). The meeting is scheduled for:
`
`Date: September 1, 2005
`Time: 2 PM - 3 PM
`Location: 1451 Rockville Pike, Conference RoomE, Rockville, :tvm 20852
`CDER participants: To be detennined
`
`Please have all attendees bring photo identification and allow 15-30 minutes to complete security
`clearance. If there are additional attendees, email that infonnation to me at
`wheeloust@cder.fda.gov so that I can give the security staff time to prepare temponuy badges in
`advance. Upon anival at FDA, give the guards either of the following munbers to request an
`escort to the conference room: Teresa Wheelous or the division secretaty at 301-594-2850.
`
`Additionally, please email your discussion questions to me in MS WORD f01mat.
`
`Provide the backgrmmd inf01mation for this meeting (one copy to the IND and 9 desk c.opies to
`me) at least one month prior to the meeting. If the materials presented in the inf01mation
`package are inadequate to justify holding a meeting, or if we do not receive the package by
`
`Page 1 of2
`
`Biogeo Exhibit 2291
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`August 2, 2005, we may cancel or reschedule the meeting.
`
`CDR Teresa Wheelous, R. Ph.
`Senior Regulatory Management Officer
`Office of Drug Evaluation I
`Division of Neurology Products
`HFD-120
`1451 Rockville Pike
`Rockville, MD 20852
`Telephone (301) 594-5504
`Fax (301) 594-2859
`
`Page 2 of 2
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
