Cell Therapeutics vor Tounaround?

The EXTEND TRIAL and Pixantrone

Link : www.gekkowire.com/?p=2256#more-2256

STEM CELLS ?!?
die würde ich eher kaufen !
GM

Ganz interessantes Q&A...

Link: www.gekkowire.com/?p=2281

Dauert ja auch nicht mehr lange.

bald heißt es top oder flop

FDA Dates for Cell Therapeutics (CTIC), CombinatoRx (CRXX), Labopharm Inc (DDSS) and Cadence Pharmaceuticals (CADX) Added to FDA & BIOTECH Calendar

Expected FDA Decision Dates added for CTIC, DDSS, CRXX and CADX

Laurel, MD (PRWEB) January 30, 2010 -- www.profeticconsult.com Prophetic Consulting LLC a leading provider of independent investment research and biotech stocks news on small and micro-cap biotechnology and pharmaceutical companies provides latest event updates on its FDA & Biotech calendar for (CRXX), (CTIC), (DDSS), (CADX), The following updates were made:

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).

Labopharm's novel formulation of trazodone is currently under regulatory review in the U.S. with an action date under the Prescription Drug Users Fee Act (PDUFA) of February 11, 2010. Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier's manufacturing facility. The letter did not raise any efficacy or safety issues.


CombinatoRx, Incorporated(NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed’s submission, including a recent amendment by Neuromed to the Exalgo NDA.

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lieg ich da richtig
wird wieder verschoben auf 22.02!???
danke
lg

Es bleibt beim 10. Februar....Der 22. galt für CombinatoRx.

und wie siehst du die chanchen!??
danke
lg

wie immer hier ;-)

und das schlimme ist man kann es komplett nicht einschätzen. Aber risen Käufe gab es in den letzten Tagen. Mal sehen

ob es heute genauso wie bei anderen Firmen die vor der Entscheidung der FDA stehen nach oben zieht. lg

Soviel Zeit bleibt ja nicht mehr... Bei wem gehts gerade hoch?

War gestern auf jeden Fall der bringer. FDA Termin steht vor der Tür. Das Problem bei CTIC steht der offizielle Termin erst am 24.04 fest

Die habe ich auch auf meiner Watchlist...Sollte wohl häufiger mal reinschauen...
Wieso 24.04.? Für mich steht noch der 10. Februar als erste FDA Termin fest...

10 ist auch der erste Termin aber in dem FDA Kalender ist der April angestrebt für die Entscheidungsfindung. Kann aber auch schon nächste Woche passieren. Das wäre sau geil .

Weit über 4 Mill.Stücke gehandelt und Plus Minus Null.Wie fast jeden Tag.Wird Zeit das der 10.Febr.kommt.

Cell Therapeutics (NASDAQ: CTIC) has survived more than one near-death experience in the past, and CEO Jim Bianco has described 2009 as a “tight-wire act.” So pretty much the whole farm is riding on this panel vote. The company, which ran down to less than a couple of weeks of cash at one point last year, doesn’t have any marketed products generating cash at the moment and nothing besides pixantrone with a legitimate shot at imminent FDA approval. Amazingly, it has burned through more than $1.4 billion of capital since its founding in 1991 without ever becoming profitable. Yet the company has been so prodigious at convincing investors to keep writing checks, and so popular with the fast-money crowd, that it now has an astonishing 574 million shares outstanding. That’s more than Celgene (NASDAQ: CELG), a profitable maker of blood cancer drugs, which has a market capitalization of $26 billion.
James Bianco

James Bianco

The question of little Cell Therapeutics, and whether it will ever get within hailing distance of profitability, really hinges on a single study of 140 patients that doctors review next week.

“We do expect U.S. approval,” Cell Therapeutics president Craig Phillips told investors on January 14, during a presentation at the JP Morgan Healthcare Conference in San Francisco.

Before diving into the nitty-gritty of the medical evidence, a little bit of business background is necessary. Cell Therapeutics obtained pixantrone in 2003 when it paid $236 million to acquire Italy-based Novuspharma. The drug is a modified form of an anthracycline chemotherapy. Anthracyclines are potent cell-killing agents commonly used in patients newly diagnosed with lymphomas. They can induce long-term remissions, but they also can cause heart failure if they are used more than once. Novuspharma designed pixantrone to have the cell-killing power of an anthracyline infusion, without damaging the heart.

If the treatment is approved, Cell Therapeutics officials estimate the company can tap into a market of about 10,000 U.S. patients each year who are on at least their third round of treatment for aggressive non-Hodgkin’s lymphoma. Cell Therapeutics uses Cephalon’s bendamustine (Treanda), which costs $44,000 per patient, as a comparable benchmark on price, Phillips told investors last month. Assuming Cell Therapeutics captures one-third of the patient population, pixantrone could generate …Next Page »

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 twitter.com/ldtimmerman.

So allmählich müsste sich der Kurs mal bewegen ,und wenn es erstmal nur Spekulativ ist.Ist ja nicht mehr lange hin.Bin auf den Termin mal gespannt.(Verdoppelung oder mehr.)Wir werden sehen.

Der Kurs wird derzeit extremst gedeckelt...Ich für meinen Teil werde einen SL setzen. Habe das ungute Gefühl das die FDA mehr Daten haben will und noch eine Studie einfordert. Wenn das passiert, gehts sicherlich auf 70-80 Cent runter....

wird die FDA bezüglich des neuen Medikaments Pixantrone von CTIC entscheiden. Denke es fällt dort die initiale Entscheidung ob die Datenlage gut genug ist oder ob bis zum April noch Daten nachgreicht werden müssen. Wird am 10 entschieden, dass es ausreichend ist wird es einen riesigen Kurssprung geben.

glaube
dass noch spekulativ gekauft wird!
aber sicher wäre es besser
bei den amis zu kaufen!
lg

Bis sie wieder den Deckel drauf knallen...