CTIC - Cell Therapeutics Inc. (NASDAQ)

[DogDayTrader]

The FDA has not made it's final decision on this yet!! this was only the advisory panels recomedation. Although The FDA usally follows the the advisory panel's recommendation, they do not have to follow it. CTIC still has time to answer or adress any questions on the trial, which may sway the FDA's decision on April 23rd.
am I off in left field with this outlook, or is there anyone else that may see things the same way?
I made some with this, but I am still in long on CTIC.

Like you mentioned, the FDA has not ruled yet. However, considering the fact that the panel voted 9-0 against approval recommendation and sighted that the trial data was not sufficient to support approval, it don't see how the FDA could rule in their favor.

Make no mistake this was a major setback for CTIC, not having funds to support another trial means dilution is most likely on the way. The one silver lining is that their drug addresses a form of cancer for which there is no current treatment.

DDT

[iseeppl]

I got this news from 'The Street', the author is Adam Feuerstein.

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Rodman is the healthcare investment banker of last resort, the go-to financier for the bottom of biotech's barrel. And yes, Rodman has raised money for Cell Therapeutics in the past, most recently in January. So when Rodman's biotech analyst gives up on Cell Therapeutics, you can be darn sure the future of the company is in very dire straits.


Cell Therapeutics' shares are hanging stubbornly around the 70 cents level, remarkable given the gravity of the company's situation. That's not likely to last long, however. At this point, Cell Therapeutics isn't worth any more than 10 cents a share, and that's being generous with valuation.

The FDA is expected to announce its approval decision for pixantrone on April 23. The drug has essentially zero chance of being approved at this time, given the FDA's vociferous criticism of the pixantrone clinical data in non-Hodgkin's lymphoma (NHL) coupled with the 9-0 negative vote by the advisory panel.

Cell Therapeutics needed to raise more money with or without pixantrone's approval. The latter scenario makes the job all that much tougher. Bankruptcy is a real possibility if Cell Therapeutics doesn't find a way to raise more cash and pay down its debt. Even if the company manages to complete a financing, pixantrone's commercial potential is forever stunted, if not altogether dead.

At the end of February, Cell Therapeutics reported a cash position of $51 million. The company is burning approximately $7-8 million per month, which means the current cash on hand runs out in August.
Cell Therapeutics' cash crunch is exacerbated by the $40 million in convertible debt that the company must figure out a way to repay before July 1.

All in, Cell Therapeutics needs to raise about $70 million just to remain in business through the end of the year. At the current stock price of around 70 cents, this would require Cell Therapeutics to sell 100 million shares of common stock, bringing the company's total share count to almost 720 million.

Even if Cell Therapeutics could manage to launch a branded pixantrone in 2014-2015 with a premium price tag, doctors who treat NHL patients would have access by that time to generic versions of Doxil, or doxorubicin, the anthracycline used most commonly to treat lymphoma patients. [Pixantrone and Doxil both belong to the anthracycline class of cancer drugs.]

The only way a branded pixantrone could gain traction over a cheap generic doxorubicin would be if the former were less cardio-toxic. Based on the pixantrone clinical data presented Monday, that scenario isn't likely.
Die-hard supporters of Cell Therapeutics might be clinging to the prospect that Novartis(NVS) could still swoop in to partner pixantrone or even buy out the company entirely. The dicey patent life of pixantrone and the long runway to any approval essentially kills that outcome.

The FDA did tell Cell Therapeutics Monday that it could allow sick-and-dying lymphoma patients access to pixantrone prior to the drug's approval. Unfortunately, the best Cell Therapeutics can do financially under a so-called expanded access drug program is to recoup operating costs related to pixantrone. FDA will not allow Cell Therapeutics to generate any profits on pixantrone until the drug is formally approved.

Cell Therapeutics' outlook doesn't improve much if the company decides to ditch pixantrone entirely. Its only late-stage candidate is the cancer drug Opaxio. But remember, Opaxio is just the new brand name for Xyotax, a reformulation of the chemotherapy drug paclitaxel that failed to meet primary endpoints in a series of phase III lung cancer studies in 2005.

European regulators rejected the drug's marketing application last year. Cell Therapeutics is now pinning Opaxio's hopes on an ovarian cancer study that is taking forever to enroll patients. Cell Therapeutics tried to convince the independent group running the ovarian study to conduct an interim analysis of the data this year, but the group refused, choosing instead to stick with a plan that won't yield data until 2011 or perhaps even 2012.

Even if the Opaxio data are positive, it's not entirely clear if Cell Therapeutics can use the study as the basis for an approval filing with the FDA. Opaxio is not much to build around a future for Cell Therapeutics.
After Opaxio, Cell Therapeutics has brostaciclin, but this cancer drug is still in early-stage studies.

Cell Therapeutics has burnt through $1.4 billion in cash since 1991, with little to show for it, yet the company has managed to stay afloat. Monday's pixantrone setback is serious and may finally put Cell Therapeutics out of business for good.

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