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AVEO Pharmaceuticals, Inc. Message Board

  • crecy_war_knight crecy_war_knight May 1, 2013 10:48 PM Flag

    May 2 at the ASCOMM

    May 2, 2013: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
    Center Date Time Location
    CDER May 2, 2013 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
    Building 31
    The Great Room (Rm. 1503)
    White Oak Conference Center
    10903 New Hampshire Avenue
    Silver Spring, Maryland
    Agenda
    During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma.

    During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

    Meeting Materials
    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

    Background Material:
    2013 Meeting Materials, Oncologic Drugs Advisory Committee
    Public Participation Information
    Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before April 18, 2013.
    Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. on May 2, 2013. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 10, 2013.
    Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 11, 2013.

    Webcast Information
    CDER plans to provide a free of charge, live webcast of the May 2, 2013, meeting of the Oncologic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2013 Meeting Materials, Oncologic Drugs Advisory Committee.

    CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

    Contact Information
    Caleb Briggs, Pharm.D.
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993-0002
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: ODAC@fda.hhs.gov
    FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting
    A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

    Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at (301) 796-9001 at least 7 days in advance of the meeting.

    Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

 
AVEO
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