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Cell Therapeutics' Upcoming FDA Worries

2. Does Cell Therapeutics really have a Special Protocol Assessment?

A Special Protocol Assessment (SPA) is essentially a formal agreement reached between a drug company and the FDA that says the design and endpoints of a phase III clinical trial are sufficient for a drug's approval.

Cell Therapeutics executives, including CEO Jim Bianco, have stated repeatedly in public that the EXTEND study of pixantrone was conducted under an SPA from the FDA. Many of the company's recent press releases, including one from April 14, 2009, also make the claim.

But the SPA claim is missing from Cell Therapeutics' filings with the Securities and Exchange Commission. The EXTEND trial is discussed in every one of the company's 10-K reports since 2003, but never does the company state that the study has an SPA.

Cell Therapeutics issued a press release on March 4, 2004 to announce the start of the EXTEND study. The SPA is mentioned but in an indirect way:

"Cell Therapeutics, Inc. announced that the U.S. Food and Drug Administration has provided guidance through the Special Protocol Assessment (SPA) process for a randomized sic pivotal trial of Pixantrone in the treatment of relapsed, aggressive non-Hodgkin's lymphoma (NHL)," the press release states. Emphasis added.

"Provided guidance?" What does that mean, exactly?

This may seem like a minor point in the grand scheme of things, but it could also be vitally important, especially if FDA has a problem with the smaller-than-designed enrollment in the EXTEND trial. If the EXTEND trial was not conducted under an SPA and FDA finds data from 140 patients insufficient, the agency could ask the company to conduct an entirely new study as a condition for pixantrone's approval.

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