Cell Therapeutics FDA Panel Primer: Take Two
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.