Advaxis, Inc.
Advaxis Receives FDA Response to Orphan Drug Filing
Published in Cancer Weekly, June 23rd, 2009
Advaxis, Inc. (OTCBB:ADXS) received the FDA letter late on June 1 denying the company's request for Orphan Drug Designation (ODD) for the use of ADXS11-001 in invasive cervix cancer. The FDA stated their market definition for invasive cervical cancer prevalence (including all those who had been cured) is over the 200,000 person cutoff. Further, the applicability of ADXS11-01 for a precursor condition, cervical intraepithelial neoplasia (CIN) was considered by the ODD as an early manifestation of the disease. No prevalence estimate for CIN was provided in our original application. There was no issue raised about efficacy.
Advaxis Chairman and CEO Thomas Moore commented,...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Cancer Weekly
Source: Cancer Weekly (2009-06-23)
More Articles from Cancer Weekly
- Cancer Gene Therapy
Findings in cancer gene therapy reported from University of Pennsylvania, Medical Department - Cancer Gene Therapy
New cancer gene therapy research from A. Azatian and colleagues discussed - Cancer Gene Therapy
Report summarizes cancer gene therapy study findings from Hokkaido University, Medical Department - Cancer Gene Therapy
Research on cancer gene therapy reported by E. Kuwada et al - Cancer Vaccines
Data on cancer vaccines published by researchers at National Cancer Institute - Cancer Vaccines
New cancer vaccines study findings recently were published by researchers at University of California - More from this issue of Cancer Weekly
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
