BOSTON, Mass. (
) -- It appears the
Food and Drug Administration
(CTIC - Get Report)
are at odds about the game-changing attributes of the latter's experimental cancer drug pixantrone for the treatment of non-Hodgkin's lymphoma (NHL).
In a strangely worded press release issued last Monday, Cell Therapeutics said that "FDA opts for standard review" of pixantrone. That would be a huge disappointment, of course, since a standard review takes 10 months. The Street's expectation -- and the company's guidance -- was that the FDA would grant a priority, six-month review.
But then the press release states, "Cell Therapeutics to discuss merits for priority review -- final decision due September 4."
Discuss merits with whom? The company doesn't specify. CEO Jim Bianco is quoted in the release saying, "We look forward to working with the FDA and their final decision on our request for priority review."
"Final decision?" So, the FDA opting for standard review was a preliminary, non-binding decision? It sounds as if Cell Therapeutics is appealing the FDA's ruling, hoping to convince the agency to change its mind and speed up the pixantrone review.
Nothing, it seems, is ever straightforward when it comes to Cell Therapeutics.
For the record, this is how FDA regulations define a standard, 10-month drug review: "Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies."
And this is how FDA classifies a drug for priority, six-month drug review: "A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists."