Talk about gaming the system.
Cell Therapeutics' (NAS: CTIC) second chance in front of the Food and Drug Administration came via an unusual path. Instead of running a new clinical trial, the biotech went over the reviewers' heads, appealing the decision, which eventually led to the company's belief that the data would be reconsidered.
After resubmitting, the FDA scheduled an advisory committee, which I said was a sign that things weren't going to be straightforward.
Who knew how right I'd be?
Cell Therapeutics said earlier today that it was voluntarily withdrawing its application for pixantrone because it didn't have enough time to prepare for the advisory panel meeting on Feb. 9. The company wasn't very forthcoming about what it needed to prepare for the meeting, but I guess it's more work than can be accomplished with a few all-nighters preparing for the big test.
By withdrawing the application, the advisory panel meeting is cancelled, and Cell Therapeutics can get it rescheduled after resubmitting its application later in the year. I'll bet there are a few college students who wished finals worked that way.
Maybe the company was acting like a college student and procrastinating because it was doing something more fun. Cell Therapeutics apparently had enough time to finalize plans on what it'll call the drug if it ever makes it to market: Pixuvri. It's certainly more fun to daydream about treating non-Hodgkin's lymphoma patients, even if it is as a last line of defense after treatment with drugs such as Spectrum Pharmaceuticals' (NAS: SPPI) Zevalin and Roche (OTC: RHHBY) and Biogen Idec's (NAS: BIIB) Rituxan get a crack at them.
The move will likely delay Pixuvri's approval beyond the April 24 decision date, figure on a decision six months after the company resubmits. Whether it's a sign that Pixuvri is less likely to be approved is hard to say. Cell Therapeutics said the decision was made after communications with the FDA, so clearly an approval isn't as straightforward as the biotech was hoping for. On the other hand, perhaps the FDA gave the company a cheat sheet and the delay will help Cell Therapeutics be prepared for exactly what the advisory committee members want.
The perma-bulls can only hope the company doesn't drop out or end up in reform school.
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