Navigation Links
Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics' Pixantrone PIX301 Pivotal Trial
Date:9/27/2011

results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the FDA and/or the European Medicines Agency, that accelerated approval by the FDA of pixantrone may not be possible or occur, that CTI may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the DODP, the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DODP and/or the FDA may be different than the intent of the OND, the DODP and/or the FDA, that the OND, the DODP and/or the FDA may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review and/or resubmission of the NDA the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that the FDA may require an additional clinical trial of pixantrone, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI may not be able to provide satisfactory information in response to the FDA's Complete Response Letter, that CTI may not be able to re-submit the pixantrone NDA for accelerated approval as early as October 2011, that even if CTI resubmits the NDA for accelerated approval in October 2011 the FDA may not complete the review of the NDA within six months of resubmission, that CTI may not obtain an FDA action date by April 2012, that CTI may not obtain approval of the NDA from the FDA in the first half of 2012, CTI's ability to continue to raise capital as needed to fund its operations,
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Video: New Research Discovers Independent Brain Networks Control Human Walking
2. Facet Solutions AFRS(TM) Demonstrates Biomechanical Advantages Over Dynamic Stabilization in Independent Testing
3. Independent Clinical Results Confirm Up to a 7-Centimeter Reduction in Body Circumference Using UltraShape(TM) Non-Invasive Fat Reduction and Body Contouring System
4. Independent Physician Surveys Show if Approved, MF101 Could Become First-Line Treatment for Menopause Symptoms
5. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
6. Longevinex(R) Found to be Superior to Green Tea Molecule in Independent Human Study
7. Independent Studies Report on Possible Roles for Cylexs Immune Cell Function Assay in Monitoring of Heart and Lung Transplant Recipients
8. Seven Presentations by Two Independent Research Groups Highlight Advantages of Pressure Cycling Technology (PCT) at Scientific Symposia in Philadelphia, Boston, and New York City
9. Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer
10. Promise of Vicals CMV Vaccine Noted by Independent Experts
11. ASPIRE Independent Review Board Announces 10 Ways to Protect Participants Rights in Clinical Drug Trials and Optimize Results From Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... , July 31, 2015 Egalet Corporation ... specialty pharmaceutical company focused on developing, manufacturing and ... of its previously announced underwritten public offering of ... public offering price of $11.25 per share. The ... 1,000,000 shares issued upon the exercise in full ...
(Date:7/31/2015)... SAN DIEGO , July 31, 2015  Eisai ... Ltd. (Headquarters: Tokyo , President and ... Inc. (Headquarters: San Diego, California , ... HALO") have signed a clinical collaboration agreement to evaluate ... in combination with Halozyme,s investigational drug PEGPH20 (PEGylated recombinant ...
(Date:7/31/2015)... , July 31, 2015 According ... Market by Product (Bioimpedance Analyzers (BIA), Dual-Energy X-ray Absorptiometry ... Weighing) - Global Analysis & Forecast to 2019", published ... pegged at $911.1 Million 2014 and is estimated to ... CAGR of 9.4% from 2014 to 2019. ...
Breaking Medicine Technology:Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 2Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 3Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 4Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 2Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 3Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 4Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 5Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 6Body Composition Analyzers Market Worth $1,425.7 Million by 2019 2Body Composition Analyzers Market Worth $1,425.7 Million by 2019 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 4
... 15, 2011 Millennium HealthCare Inc. ... LLP, a Public Company Accounting Oversight Board (PCAOB) accounting ... KBL, LLP provides a combination of technology, ... businesses. Their professionals maintain an entrepreneurial spirit and a ...
... US, LLC ("Astellas") recently named Percival Barretto-Ko as ... a new position added to the company,s leadership ... Barretto-Ko will be responsible for corporate planning, business ... government affairs. "This realignment brings key ...
Cached Medicine Technology:Millennium HealthCare Inc. Engages KBL, LLP 2Astellas Expands Leadership Team With Senior Vice President of Corporate Strategy and Government Affairs 2
(Date:7/31/2015)... ... July 31, 2015 , ... Mullin/Ashley ... recognized in the 2015 Aster Awards national competition for a marketing communications campaign ... City and surrounding communities in Coastal Maryland and Southern Delaware. , A Bronze ...
(Date:7/31/2015)... ... July 31, 2015 , ... Like nearly every other form ... been advanced, upgraded, made more effective and less intrusive and painful. Leading these ... Enlargement Center. Dr. Loria currently stands as the only doctor in the United ...
(Date:7/31/2015)... New York, NY and Rockport, ME (PRWEB) , ... July 31, 2015 , ... The ... this photo op. , Glancing out of the window, he recalled that his equipment ... 215 Chrystie Street tower, he jumped out of bed. , The photo speaks ...
(Date:7/31/2015)... ... , ... Ticket Down is a reputable source of authentic USA vs. ... will face the Australia Women's National Team in two separate friendly contests. The ... and the second match will occur in Birmingham, Alabama at Legion Field. These ...
(Date:7/31/2015)... ... July 31, 2015 , ... Ticket Down is a reputable source of authentic ... Soccer Team will face the Australia Women's National Team in conjunction with their Victory Tour ... 5-2. Carli Lloyd from the USA team was awarded the Golden Ball as the ...
Breaking Medicine News(10 mins):Health News:Mullin/Ashley Associates Wins in the 2015 Aster Awards National Competition for Excellence in Medical Marketing 2Health News:Loria Medical Penile Enlargement Center to Expand, Offering Practice Partnership to Doctors 2Health News:Cheap USA vs. Australia Tickets at Legion Field in Birmingham, AL: Ticket Down Slashes Ticket Prices for Australia vs. USWNT at Legion Field 2Health News:Cheap USA vs. Australia Tickets at Ford Field in Detroit, MI: Ticket Down Slashes Ticket Prices for Australia vs. USWNT International Friendly Match at Ford Field 2
... are calling on the Federal Government to fund a new ... ,Rotavirus puts 10,000 Australian children in hospital each year, ... at doctors' surgeries with symptoms of acute diarrhoea and vomiting. ... aged six to 32 weeks, is only available by private ...
... to be "alarmingly dismal" with over 180 million urban poor ... says an industry analysis. ,At least 300 additional ... up annually to cater to the needs of 215 million ... Chambers of Commerce and Industry of India (ASSOCHAM). ...
... information management device by Intel and Motion Computing, is no ... that it is starting to ship the device to hospitals ... with patients, do their jobs on the move while remaining ... an impressive array of features such as a camera, RFID ...
... tobacco industry memo from 1969. For half a century, the ... cancer. Now, with that effort long since failed, cigarette producers ... to manufacture doubt. ,"The tobacco industry is now ... everyone knew but no one had proof," said Robert N. ...
... its distinguishing shape? Shape may be formed by cell movement, ... of which react to// influences from the local environment. Initially, ... to develop into cardiac chambers. ,In a new ... Heidi Auman, Deborah Yelon, and colleagues found, by using transgenic ...
... experts Fred R. Volkmar, M.D., and Ami Klin are part ... an individual gene and a// region of a chromosome that ... are published online in Nature Genetics and also will be ... on the largest autism genome scan done to date. The ...
Cached Medicine News:Health News:Call for Rotavirus Vaccine Funding 2Health News:Urban Poor in Dire Need of Proper Healthcare: Report 2Health News:Tobacco Companies Obstructed Science 2Health News:Tobacco Companies Obstructed Science 3Health News:Autism Gene Identified by Yale and Global Consortium 2
... duty chair with electrical operation with ... and seat rotation with click stops ... heavy duty chair with electrical operation ... mm and seat rotation with click ...
Keeler Professional Combi Retinoscope with new slimline handle and lithium or dry cell option....
Portable mini halogen light....
The MC-3 allows for simultaneous use of two lamps, with an additional built-in spare....
Medicine Products: