CTIC gets going concern warning, new ODAC date

In its annual report, Cell Therapeutics warned it doesn't have enough cash to make it through the third quarter of 2010, causing auditors to raise substantial doubt about the company's ability to continue as a going concern. Cell Therapeutics had cash and equivalents of $37.8 million as of December 31. That sent the company's already battered shares down in premarket trading, according to Reuters. The developer notes, however, that since the annual report was filed, the company raised $30 million in a stock sale.

Cell Therapeutics is developing pixantrone, also known as Pixuvri, as a treatment for patients with non-Hodgkin's lymphoma that hasn't responded to other treatments. FDA staffers have raised questions about the treatment, expressing concerns about both the drug's effectiveness as well as its safety profile.

The answers to those questions were delayed, though, due to a snowstorm that paralyzed Washington D.C. in February, when the panel was set to review Pixantrone. Cell Therapeutics announced this morning that the ODAC meeting has been reschedule to March 22, and the FDA is expected to make a final decision on approval of CTI's NDA for pixantrone by April 23.

- here's the Reuter's piece
- read CTIC's release on the ODAC meeting
- check out TheStreet's overview of the situation

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