but we are dealing with patients who have very few options. Tivo gives another option with less side effects. it is at least or better than SOC. I say release it and have another trial too. Why not allow patients to make their own life decisions. Another trial could take another year.
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
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
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.
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.
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.
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.
Caleb Briggs, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
FDA Advisory Committee Information Line
(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).
But here is a wired thing. Since I purchased the Edge I was looking to see how many more I would see on the road...I drive about 80 miles freeway each work day and I haven't seen ONE. Not ONE whats that all about?
I only mentioned the AWD as a FYI. Needed a car NOW. I don't really need AWD living in Los Angeles. I had no time to wait. Had to sell the Expedition to my daughter who is moving to Seattle, that left me with NO CAR.
This kind of high Beta #$%$ in a pre-drug review is typical in Biotects. I look at the research result which are way positive compared to the standard of care we have now. Ignore the BS.
"After review of the documents, we continue to believe there
is a good likelihood of a favorable vote," said Geoff Meacham,
an analyst at J.P. Morgan, in a research note, adding that the
reviewers appear to have no new concerns on safety or efficacy.
"Net-net, we would be buyers ahead of the panel," he said.
John Sonnier, an analyst at William Blair & Co, said in a
research note on Monday that while a focus on overall survival
benefit may raise concerns with investors, he too believes the
improved safety profile of tivozanib and the superior
progression-free survival figure will lead to a favorable vote.
I will place a complaint with the SEC if he is wrong. I will ask them to investigate if either he or his clients/friends shorted or sold AVEO before the release of his article. I would encourage others to do the same.
He really wanted to say Adam F is Full of #$%$ and Tivo will get Thumbs Up
As I said before...I like the product...hate the stock. If I owned it now I would be Selling into this little run up its had. SELL or be a Bag holder in the future.
" A significant improvement of tolerability and safety, which in turn lead to better patient compliance, along with equivalent efficacy, should be enough for AdCom recommendation for FDA approval. Combined with Tivozanib's impressive PFS data (which is consistent with the phase 2 study), the real potential value of tivozanib will not escape from the eyes of the AdCom members. "