Ever since Cell Therapeutics
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
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.