Cell Therapeutics, Inc. (NASDAQ: CTIC) is about as controversial as a stock can get in biotech. Now we have reason yet again to question whether or not this small biotech outfit can survive. The company withdrew is new drug application for pixantrone. It claims that it needs more time to prepare for an upcoming advisory committee review and more importantly it claimed that regulators were unwilling to reschedule its review.
This company has been pounded after the FDA and its panel of experts rejected pixantrone. Why this is so odd is that the company has been steadily maintaining that it was on track for an FDA approval of the cancer drug.
This appears to imply that the company is starting over. Regulators and experts objected to its development process and to the application itself with a review noting that data in the study was not adequate for any approval. If our understanding correct, Cell Therapeutics will have to file another new drug application over the next year, with a panel review thereafter.
The company simply noted, “The NDA was withdrawn because, after communications with the U.S. Food and Drug Administration, CTI needed additional time to prepare for the review of the Pixuvri (pixantrone) NDA by the FDA’s Oncologic Drugs Advisory Committee at its February 9, 2012 meeting.” It is hard to imagine that the FDA communication was positive.
Shares of Cell Therapeutics closed down 18% at $1.09 and its 52-week trading range is $0.95 to $2.46 and the new adjusted market cap is about $201 million. At the end of the September 2011 quarter, Cell Therapeutics carried about $45.2 million in cash.
JON C. OGG