Two years after Cell Therapeutics ($CTIC) took one of the worst regulatory beatings of the decade at the time the FDA and its experts rejected the company's cancer drug pixantrone, the Seattle-based biotech has pulled a puzzling about-face. After reportedly boasting for months that it was on track to win an approval, the company pulled its new NDA for pixantrone, claiming it needed more time to prepare for an upcoming advisory committee review and that regulators were unwilling to simply reschedule for a later date.
"The NDA was withdrawn because, after communications with the U.S. Food and Drug Administration, CTI needed additional time to prepare for the review of the Pixuvri (pixantrone) NDA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," the company said in a statement. And while there was no explanation of just what the FDA had been communicating, it's reasonable to assume that there wasn't much hope to glean from the exchange.
In early 2010, regulators and experts scathingly objected to Cell Therapeutics' development process and application, bluntly objecting to the data as inadequate for an approval. And Cell Therapeutics found itself opposed by Richard Pazdur, the powerful oncology drug-review chief at the agency. Now it'll be forced to start the process over again, filing another NDA later in the year and asking for a new PDUFA deadline as the company regroups yet again.
According to Adam Feuerstein at TheStreet, a longtime critic of Cell Therapeutics CEO Jim Bianco, Wall Street sources had been saying that the company has been claiming an approaching regulatory win for pixantrone. Cell Therapeutics' shares dropped about 20% on the news, landing right around $1.05.
- read the release
- here's the story from TheStreet