Per my conversation with the FDA this morning via-email I have found out that the FDA briefing documents will be made available to the public on February 8, 2010. I have posted the response from the FDA below.
Question:
Greetings Nicole,
I have a quick question about the Feb. 10, 2010 Oncologic Drugs
Advisory Committee Meeting. Do you know what date the FDA Briefing
Documents will be made public at your website for Cell Therapeutics’
drug PIXUVRI (pixantrone dimaleate) injection?
I know usually the documents are made public the same week as the
hearing, but I was just wondering if you could give me an exact date.
Many Thanks,
Geoffrey Chambers
FDA Response:
Mr. Chambers,
The background document will post on Monday to the following website:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/O
ncologicDrugsAdvisoryCommittee/ucm195226.htm
Thank You,
Nicole Vesely, Pharm.D.
LT, United States Public Health Service
Advisors and Consultants Staff, HFD-21
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane (Bldg 5630)
Rockville, MD 20857
Phone: (301) 827-6793
Fax: (301) 827-6776
Email: nicole.vesely@fda.hhs.gov
Twitter
will this give us some type of clue (positive/negative signs) as to what will happen on the 10th?
Hi Geoffrey,
Does this mean that Cell does not receive a copy until Monday or do they receive a copy of the briefing documents earlier? Do these briefing documents really prepare Cell for all questions to be asked or are there usually some surprises.
Thanks
Mike
GC,
Thanks for the info. Cant wait until Monday.
As you told us before , there will be some journalist posting negative news about Pix right before the meeting date(It had haapened yesterday).
Furthermore, the Oncologic Drugs Advisory Committee Roster is out. But i cant see Dr.Padzur name in it, does it mean that he wont attend the meeting?
The Chairman is S. Gail Eckhardt, M.D., he seems very professional. Will he sided to Pix?
Ivan
Use a spell checker…
Too late for me and others italian members of Cell Forum…….hurry upppppp…..
We need new news, not old news…………
Don’t worry i’m joking…… thank for all!!!!
However….
take a look:
28/01/2010 15:37:04
GEKKO.2
UtentiBorse
Re: Cell news (no chat)
“Background documents, draft agenda and a draft meeting roster will post to the following website 2 business days before the 2/10 ODAC meeting:
http://www.fda.gov/AdvisoryCommittees/C … 195226.htm
Nicole Vesely, Pharm.D.”
fonte: mail privata di gekko con nicole dell FDA
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