Cell Therapeutics vor Tounaround?
http://www.finanznachrichten.de/...erapeutics-drug-pixantrone-008.htm
FDA Approves NerPharMa to Manufacture Cell Therapeutics' Drug Pixantrone
SEATTLE, March 8 /PRNewswire-FirstCall/ --
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the U.S. Food and Drug Administration ("FDA") has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application ("NDA") under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. As previously announced, the FDA's Oncologic Drugs Advisory Committee ("ODAC") will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.
"FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," said Craig W. Philips, President of CTI.
About Nerviano Medical Sciences (NMS)
Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading 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, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that the FDA may not approve the NDA for pixantrone, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: deramian@ctiseattle.com
§http://www.celltherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
§http://www.celltherapeutics.com/investors
§Cell Therapeutics, Inc.
CONTACT: Media, Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200,
fax, +1-206-272-4434, deramian@ctiseattle.com, or Investors, Ed Bell,
+1-206-272-4345, or Lindsey Jesch Logan, +1-206-272-4347, fax,
+1-206-272-4434, invest@ctiseattle.com, all of Cell Therapeutics, Inc.
Web Site: http://www.celltherapeutics.com/
© 2010 PR Newswire
GLTA
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Ist der jetzt deprimiert?
hihi
LOL
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As with any biotech investment, the jury is still out on Pixatrone with the FDA indicating that there could be a link to heart failure. And the regulatory agency also was concerned that CTIC's study involved less patients than what the FDA expected and what the company planned.
Nevertheless, an advisory panel to the FDA will review the Pixantrone on March 22 and will submit its recommendation (a non-binding recommendation) to the FDA. The final say is reserved for the FDA, which is expected to give its final Yay or Nay on April 23.
So, it will not take long for CTIC investors to know if they were wise or mistaken. But anyone who remembers Dendreon (NASDAQ:DNDN) trading at $3/share will not ignore the potential with CTIC.
Disclosure: Author holds a long position in CTIC
http://seekingalpha.com/article/192845-c...
Sentiment : Strong Buy
From yahoo board
Holzer Holzer & Fistel, LLC, ist die Untersuchung möglicher Verstöße gegen die US-amerikanischen Wertpapiergesetze von Cell Therapeutics, Inc. ( "Cell Therapeutics" oder das "Unternehmen") (NASDAQ: CTIC). Die Untersuchung konzentriert sich auf, ob eine Reihe von Aussagen in Bezug auf Unternehmen Cell Therapeutics ', waren seine Aussichten und ihre Tätigkeit wesentlich falsche und irreführende zum Zeitpunkt sie vorgenommen wurden.
http://ih.advfn.com/...nmona&article=41936626&symbol=N%5ECTIC
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Luke Timmerman 3/19/10
Seattle-based Cell Therapeutics (NASDAQ: CTIC) is getting ready, one more time, for its make-or-break moment. The big East Coast snowstorm of mid-February postponed this day of reckoning a few weeks, so the company is now getting ready to make its case in front of a committee of cancer drug experts on Monday, March 22.
For those of you just tuning in to the latest chapter in the 19-year drama known as Cell Therapeutics, this panel will be a big milestone in the company’s history. Cell Therapeutics has burned through more than $1.4 billion of investors’ money since inception, and at this point, has no products currently generating cash flow. Its application to market pixantrone in the U.S. for non-Hodgkin’s lymphoma patients is vital, since it represents Cell Therapeutics’ only serious chance at generating some sales, pronto.
I wrote an in-depth preview story on February 3 about the history of this drug, and the clinical trial data underpinning it, which is still a good guide for what to expect on Monday. Since that story, the FDA staff also published their own critical take on the Cell Therapeutics drug. The staff review noted that the treatment has “substantial” side effects, and wasn’t tested in nearly as many patients as the company had originally planned.
On Monday morning, I’ll be listening to the webcast and covering it here live at Xconomy. Important as this FDA panel will be, people should keep in mind this isn’t going to be the last word on Cell Therapeutics or pixantrone. The FDA has the authority to decide whether to approve the drug for sale in the U.S., and while it usually follows the advice of its panels, it doesn’t have to. The agency’s deadline to complete its review is April 23.
What will happen to Cell Therapeutics if the committee says the drug isn’t ready for the marketplace? The stock will surely crash, in a heartbeat. But the company might be able to keep on going, at least for a while. Cell Therapeutics had $54.9 million in cash and investments on its balance sheet on September 30, and burned through about $17 million of that stash in the fourth quarter, leaving it with $37.8 million in cash and investments heading into this year. That’s not enough to run the business through the end of this September, the company said in its annual report.
So the pressure will be on, but that’s really nothing new. If history is any guide, CEO James Bianco will just find some more investors who are willing to give him some more money. To borrow a cliché from baseball, hope springs eternal in biotech.
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman
http://www.xconomy.com/seattle/2010/03/19/...a-panel-primer-take-two/
P.S.Bin auch schon länger dabei und ich warte einfach mal ab.
Gruss
Dann habe ich gelesen, dass der CEO ein ständiger Dilutierer ist (Genta lässt grüßen), das die Studie nicht die Rahmenbedingungen der FDA erfüllt hat, das die Ergebnisse nicht frei von Zweifeln sind, das das UN ohne die Zulassung vor dem Aus steht. Das wird natürlich nicht passieren, sondern es werden neue Aktien ausgegeben. Alles in allem klingt das für mich wenig vielversprechend.
Trotzdem alles Gute.
Die Amis sind für Überraschungen gut, das bestimmt!
bei cell schaut es im vorfeld nicht gut aus, muß schon sagen miserabel,
allerdings novelos wurde hochgelobt und wird es mit nov 05 evtl nicht einmal bis zur fda zulassung schaffen(oder vl doch) ich bin noch am überlegen ob ich heute noch mit einer kleinen posi rein soll. gibt es ein kursziel bei positiven ausgang???????
Wie groß ist den der marktfür cell bei zulassung?