Mark Your Calendars, Biotech Investors

Ever since Cell Therapeutics (Nasdaq: CTIC  ) decided to appeal the 2010 Food and Drug Administration rejection of its non-Hodgkin's lymphoma drug pixantrone, we've only heard the company's side of how the process was going -- not that the message was always clear. The FDA doesn't speak openly about drugs in the approval process.

But the FDA has finally spoken -- at least with its appointment calendar -- and it sure doesn't look like the appeal is going to be a straightforward process. Yesterday, Cell Therapeutics said that the FDA has scheduled an advisory panel meeting for Feb. 9.

My guess is that this isn't a good sign. If the appeal was going smoothly and the higher-ups at the agency had ordered the reviewers to accept Cell Therapeutics' explanation, there wouldn't seem to be much of a reason to hold an advisory-panel meeting. On the third-quarter conference call, CEO James Bianco pointed out the pickle it would put the FDA in: "It's difficult to see what it would be like to go back to panel in the setting of 'Oh, by the way, you saw this drug last year; we told you the trial failed. However, the company appealed and we now believe that the trial didn't fail.'"

In fact, advisory panels for second-attempt approvals are rare. MELA Sciences (Nasdaq: MELA  ) had one for its melanoma-detection device, MelaFind, but I'm fairly certain there wasn't one the first time around. Other controversial rejections like Dendreon's (Nasdaq: DNDN  ) Provenge didn't induce the agency to call one on its second -- successful, I might add -- attempt at an approval.

The optimists will say an advisory committee also means there's a chance for an approval. If there's a 100% chance the agency was going to reject the application again, why would it need an advisory-panel meeting? While that's a valid argument -- and I certainly wouldn't put the chance of rejection at 100% -- the agency may still be negative and just looking for some backing.

It may be wishful thinking on my part, but as much as the agency seems like a dictatorship sometimes, I get the feeling the leadership doesn't want to come across that way. The appeal process requires the agency to act as judge and jury, since Cell Therapeutics had to appeal the original decision back to the agency. By calling the advisory committee, the FDA can get a panel of outside experts to support its case and not look quite as tyrannical.

Of course, the Oncologic Drugs Advisory Committee reviewed pixantrone the first time as well, recommending 9-to-0 against approving the drug. So maybe the agency is just trying to share its tyrannical rule.

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Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Dendreon. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.


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  • Report this Comment On January 05, 2012, at 7:33 AM, Hufington wrote:

    "...and it sure doesn't look like the appeal is going to be a straightforward process. Yesterday, Cell Therapeutics said that the FDA has scheduled an advisory panel meeting for Feb. 9"

    ODAC panel review is the straightforward process for any cancer drug going through the approval process. How can you twist FDA protocol into a looming disaster for CTI, unless you have ulterior motives for driving this stock down?

  • Report this Comment On January 06, 2012, at 4:37 PM, TMFBiologyFool wrote:

    It's not straightforward for a second review. I don't know of any drugs that have had one for their resubmission.

    Straightforward would be the FDA agreeing with CTI and approving the drug without one.

    I don't own the stock and wouldn't short it either. Potential for a surprise approval may be small, but it would be extremely painful.

    Good luck with your gambling money.

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