Cell Therapeutics Lymphoma Drug Fails to Win FDA Approval

4/9/10Follow @xconomy

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it can win approval in Europe. The company is planning to submit that application in the three-month period that ends in September.

Getting an approval in the U.S. is a remote possibility, according to David Miller, an analyst with Biotech Stock Research in Seattle. A new trial would require 300 or more patients, many of them in the U.S., to address some of the FDA panel’s prior concerns, and it will take years to enroll them all, Miller said in a note to clients. The trial would cost $30 million to $50 million, which isn’t something the company can afford with its existing cash reserves.

Still, Cell Therapeutics has raised $1.4 billion since its founding in 1991, and CEO James Bianco was able to lead a $20 million fundraising from investors even after the FDA panel’s brutal dismissal of the company’s drug. While the company said it sees reasons for hope with its “expanded access” program to offer the drug in the U.S. to patients while it is being studied, plus the chance of a European approval, Miller dismissed those possibilities.

“CTI can keep preying on novice investors with stories about EU approval and Expanded Access. At some point, however, we think they will run out of novices and the market cap will return to levels appropriate with their cash and debt situation,” Miller wrote.

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