The FinancialContent Network     SocialPicks Community   |   MarketMinute Monitor   |   MarketMinute Market Updates   |   MarketMinute Stock News
SocialPicks
   Sign Up   |   Log In   |   What is SocialPicks?     
9 pts

Opinion on  Dendreon Corp (DNDN)     Sector: Healthcare  >  Industry: Biotechnology & Drugs
Updated FDA, Clinical Trial Calendars: CTIC, DNDN, MRX, JNJ, MEDX

Apr 14, 2009 12:17 PM GMT
Mikerun
Return Risk
+1.04% MID
Principal

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars .
 
The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/14/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. 
 
 
The Clinical Trial Calendar includes 126 entries through 4/14/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
 
1.) Cell Therapeutics (CTIC): On 4/14/09, CTIC began a rolling submission of a NDA to the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission during 2Q09 and will request priority review (six month) which if granted could lead to an approval decision from the agency during 4Q09. Click here for my most update recent article on CTIC and follow this link for my overview article from two months ago.
 
2.) Dendreon (DNDN): DNDN will release the highly anticipated results this morning with a conference call schedule for 9am (ET) for its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. In March 2007, a FDA advisory panel recommended approval of Provenge, but the agency declined to approve the therapeutic cancer vaccine until additional data was available from the IMPACT study (with a target of at least a 22% reduced risk of death versus placebo to file for FDA approval).
 
3.) Medicis Pharma (MRX): Ipsen (France: IPN.PA) and its U.S. partner Medicis MRX announced today that the companies are in active labeling and Risk Evaluation and Mitigation Strategy (REMS) discussions with the FDA for their pending BLA seeking marketing approval for Ipsen’s botulinum toxin type A product in both therapeutic and aesthetic indications. Analysts expect a 2H09 approval for Reloxin, which reflects a delay from the original PDUFA decision date deadline of 4/13/09. Reloxin would compete with Allergan's (AGN) Botox as a cosmetic treatment for wrinkles and is already approved for use in over 20 countries outside the U.S. (marketed as Azzalure).
 
4.) Medarex (MEDX), Johnson & Johnson (JNJ): MEDX announced that it will receive a undisclosed milestone payment from its licensing partner, Centocor Ortho Biotech (a JNJ division), in connection with the Canadian marketing approval on 4/13/09 for SIMPONI (golimumab or CNTO 148) as a once-monthly sub-que injection for the treatment of adults with active forms of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
 
SIMPONI is a new, human anti-tumor necrosis factor (TNF) monoclonal antibody that was generated by Medarex's UltiMAb technology that targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha. The PDUFA decision date deadline for the drug is 4/27/09 for U.S. marketing approval.
 
Disclosure: No positions.


DNDN:  This call was made on 04/14/09 @ $21.4
Rating:   Negative   $21.4 (04/14/09)
Closed:   04/14/2009 @ $21.4 (+0.00% in 1 hour)


Comments (4)

Add Comment

Arrow_up
Arrow_down
chuntian   N/A     1 point   commented 678 days ago reply

The five fingers shoes' shoe sole cannotvibram five fingers performa jane look like other vibram bottom to meet Shui Jiuhui on the hard rock becomes equally very slippery. The five fingers shoes can the tip of the toe and the vibram five fingers classicfoot heel very safe protection, the only worry be progress sand anything in the sand beach. The simple separated toe does not vibram five fingers flow look like the oar shoes, because the oar shoes easy to fall, but the five fingers shoes firmly put in the foot, even if in rowing's time, for vibram five fingers kso example some small and narrow ship like cabin quite narrow and small river kayak. Usually, the five fingers shoes may also use when the surfing vibram five fingers kso trek the shoes, put on the both feet same feeling which the five fingers shoes' both feet and does not put on shoes to be keen, controlvibram five fingers performa equally are also Like a glove-like VIBRAM FIVE FINGERS shoes, interesting Vibram five-fingers shoes may initially put toes into this strange shoes or some strange, but you spend 10 vibram five fingers moc years time, you will find, in fact, this is also the only gloves to wear parts into a glove, and help our optical toe from harm. In the first use of Vibram five-fingers shoes before light filled walk 2 minutes and let your feet can adapt to the feeling of walking bare feet and shoes (wear gloves? lol) < worn you can feel the feet touch the real true is vibram five fingers sprint passed to your brain, the soles of the feet on the ground plate affixed to the feel. Then you can be more flexible control over your feet, in the face of the surface of a moist and smooth. handy.

Wears the glove to the foot- Vibram five fingers -Interesting Vibram five fingers shoes Like a glove-like VIBRAM FIVE FINGERS shoes, interesting Vibram five-fingers shoes may initially put toes into this strange shoes or some strange, but you spend 10 years time, you will find, in fact, five fingers shoes this is also the only gloves to wear parts into a glove, and help our optical toe from harm. In the first use of Vibram five-fingers shoes before light filled walk 2 minutes and let your feet can adapt five fingers to the feeling of walking bare feet and shoes (wear gloves? lol) worn you can feel the feet touch the real true is passed to your brain, the soles of the feet on the ground plate affixed Vibram shoes to the feel. Then you can be more flexible control over your feet, in the face of the surface of a moist and smooth. From hiking to climbing boots and Vibram five fingers shoes shoes to work boots, the ubiquitous yellow flag in many vibram sole can be found. Vibram, Italian famous rubber manufacturers, since 1947, began the production and vibram 5 fingers manufacture of high-quality rubber wear-resistant. From aircraft tire quality, extended to soles, and more. The concept of this pair of five interesting Vibram five fingers is Vibram vibram fingers shoes as a sole manufacturer since the first independent production of own products. First of all, of course, the characteristics of the five independent toes, as opposed to five fingers sale the popular majority will not separate from the shoe toe, this shoe mobile space, the toe is not very large, subject to space restrictions, shoes in the external forces, the majority of the most concentrated in the truck on the thumb. Wear this shoe double fun finger, you can very balanced and safely walk, keep the feet to the correct position, five toes can sensitive feeling of the body, regulating body posture, to Vibram fivefingers maintain the correct posture for walking, you can

Arrow_up
Arrow_down
shijiu   N/A     1 point   commented 669 days ago reply

wrong as they are well breitling suited for all kinds of occasions. They can be worn and will still tag heuer look good at formal events or on casual functions. Some ladies even cartier get different styled ones for various occasions and to match different hublot dressings. Gold lasts forever and so they signify eternity. As such, patek philippeif you are thinking of buying a gift for your wife omega watches or girlfriend for her birthday or the coming Valentine's day, fake watches a ladies' gold watch will be a good choice. With so fake rolexmany designs and styles available, you will definitely replica watches be able to find one that

Arrow_up
Arrow_down
shijiu   N/A     1 point   commented 669 days ago reply

suits her well. If the price replica handbags is what is stopping you from getting one of those beautiful ladies gold watches for designer handbags your love ones, you may be happy to learn that there are inexpensive ones available too. gucci handbags Undoubtedly, if you decide to get something that is made of chanel handbags solid gold, it is going to louis vuitton handbags cost you a bomb but there

Arrow_up
Arrow_down
ozipek   N/A     1 point   commented 414 days ago reply

biber hapı | Maurers | zayıflama | Lw6090 | altın çilek | Ozon Yağı | Red Pepper | fx15 | radian | Tengda Zayıflama Hapı | Tengda Kullanımı | Tengda Kullanıcı Yorumları | Tengda Sipariş | Tengda Hakkında | Tengda İçindekiler | Tengda Etkileri | Tengda Yan Etkileri | Maurers | Maurers Kullanımı | Maurers Kullanıcı Yorumları | Maurers Sipariş | Maurers Hakkında | Maurers Zayıflama Hapı | Maurers İçindekiler | Maurers Etkileri | Maurers Yan Etkileri |


Your Comment



ROCK-STAR INVESTORS
Rank Name Sharpe Ratio Avg Return Followers
1 21.10 +34.36% 531
2 18.14 +36.28% 286
3 17.66 +23.07% 83
4 13.47 +13.37% 69
5 12.13 +132.16% 102


POPULAR STOCKS
Symbol Company Name Sentiment

TODAY'S HEADLINES

TODAY'S TOP PICKS

 
Dendreon Corp (DNDN)
   SocialPicks Sentiment:   

   This Quarter's Sentiment:
All:
75.0%
Top:
75.0%




Latest Picks by Mike Havrilla
Symbol SP Sentiment Rating Return Since
AMRN Positive +86.01% 11/29/10
IBB Positive +39.69% 11/22/10
EXAS Positive +35.19% 10/21/10
BIOD Positive -83.37% 10/17/10
LCI N/A Positive -21.73% 10/06/10

View All >
   
Mike Havrilla previously rated DNDN
Positive -73.49% Healthcare Conference Update: A New Strategy for ImmunoCellular (OTC: IMUC.OB)
01/17/2010
9
Positive +10.54% QI / Mentor Capital Updates: New Video, Upcoming Presentation, Financials
01/02/2010
9
Positive +1.08% Mentor Capital Plans Early ’10 Launch of Cancer Vaccine Active Index Fund
12/21/2009
9
Positive -4.55% Cancer Vaccines: Investing Opportunities beyond Dendreon (NASDAQ: DNDN)
11/28/2009
9
Positive -2.51% BioMed News Bytes: CombinatoRx, Dendreon, Photocure, Pozen
11/20/2009
9
Positive +5.55% New Global Equity Index to Track Immunotherapy, Vaccine Stocks
11/04/2009
9
Positive -0.86% New Stock Indexes to Track Trends in Healthcare Sector
10/28/2009
9
Positive -3.58% Quantum Immunologics: Developing Universal Therapeutic Cancer Vaccine
10/25/2009
9
Positive +4.25% ImmunoCellular (OTC: IMUC.OB): Top Gainer in Cancer Immunotherapy Index
09/16/2009
9
Positive -0.38% Quantum Immunologics: Rodman Conference Recap
09/15/2009
9
Positive +12.11% Mentor Capital (MNTR.pk): A Risk-Mitigated Call Option on QI’s Cancer Immunotherapy
08/29/2009
9
Positive +0.30% Mentor Capital (MNTR.PK) Top Gainer in Cancer Immunotherapy Index
08/28/2009
9
Positive -1.70% Mentor Capital (MNTR.PK): A Stealth Cancer Immunotherapy Play
08/26/2009
9
Positive -1.59% New Indexes to Track Healthcare Trends and More
08/04/2009
9
Positive +14.05% Access Pharma: A Cancer Biotech Call Option Trade
05/27/2009
9
Positive -20.61% Bullish on DNDN ...
04/14/2009
0
Negative -225.72% BioMed Stock Movers: DNDN, EXAS, KG
04/08/2009
9
Negative +3.10% Bearish on DNDN ...
04/07/2009
-1
Positive -0.73% FDA Calendar Updates: SNTS, CEPH, AZN, DNDN, GILD, NVO
04/06/2009
9
Positive +89.63% Calendar of 163 FDA Decisions and Clinical Trials
01/21/2009
9
Positive -3.25% UpDown Virtual Investing: Earn Real Money with Zero Risk
12/28/2008
9
Positive +2.90% A New Global Healthcare Composite Index
11/23/2008
9
Positive +0.00% A New Index of Emerging Biotech & Pharma Companies
11/22/2008
9





IN THE PRESS
Press_forbes Press_washingtonpost Press_wsj Press_npr Press_techcrunch