Investors Need a Peephole Into FDA Offices

Cell Therapeutics (Nasdaq: CTIC  ) is one step closer to resubmitting its marketing application for its non-Hodgkin's lymphoma drug, pixantrone. The biotech said yesterday that it had met with the Food and Drug Administration to get guidance on what it needs to do to gain approval for pixantrone.

Boy, do I wish I could have been a fly on the wall in that room.

Cell Therapeutics went over the heads of the FDA's Division of Oncology Drug Products, or DODP, to appeal the complete response letter. The Office of New Drugs, or OND, didn't overturn the original ruling and approve the drug. But as Cell Therapeutics tells it, the OND did say that the DODP needs to look at the data again.

As I see it, the meeting between Cell Therapeutics and the DODP could have gone down in one of two ways. The OND could have come down hard on the DODP internally, and Cell Therapeutics is well on its way to gaining FDA approval. Watching the FDA admit that it's wrong would be worth the price of admission.

Alternatively, Cell Therapeutics is presenting a rosy picture of the OND's opinion, and the entire meeting was spent with the DODP's personnel rolling their eyes wondering why the heck they're sitting in a meeting discussing refilling the marketing application without a new clinical trial for pixantrone.

The problem for investors is that there's no way to know which has occurred. The FDA doesn't discuss unapproved medications, so we're only getting one interpretation of the situation.

There are two major sticking points for an approval: whether the clinical trial being used for approval showed a statistically significant benefit for pixantrone and whether it's sufficient for an accelerated approval. The likelihood of changing the DODP's mind on the first one seems highly possible.

The accelerated approval is where Cell Therapeutics will have the hardest time because it's somewhat subjective. The DODP turned down Dendreon's (Nasdaq: DNDN  ) Provenge the first time and refused to even look at Roche and ImmunoGen's (Nasdaq: IMGN  ) T-DM1 application for accelerated approval. It did give Roche's Avastin and AstraZeneca's (NYSE: AZN  ) Iressa accelerated approvals, but both produced post-approval results that didn't support their initial accelerated approval.

We'll know how well the meeting really went in less than a year. Cell Therapeutics plans to resubmit its application by the end of the year, which would put an FDA decision in the first half of 2012.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of ImmunoGen. Try any of our Foolish newsletter services free for 30 days. We Fools may not 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 June 15, 2011, at 8:42 PM, danico22 wrote:

    I don't know what is going to happen with CTIC and FDA but I can assure you who has cancer will wish to try their medication 100%.People from CTIC are trying to make wonderful thinks.I wish them well and for some reason I don't worry about the stock too much.Will jump in a minute when first OK is coming.

  • Report this Comment On June 15, 2011, at 10:57 PM, jonesnj0 wrote:

    you have no clue at least this time it wasn't a complete bash job like the last" article" if you can call it that?

    The fact that Pixantrone has proven to beat Dox in trials should be enough to propel this to Approval!

    The FDA is Broken and with a thief like Pazdur at the helm of the office of new drugs just means more needless deaths!

    Killing 3 times more People then died at the world trade center is unconscionable and wrong its broke and needs to be fixed!

    How many more patients will die because of Pazdur and his band of short thieves?

    While Bash Rags like your constantly Bash a Drug and company that in the future will save many lives!

    You Better hope that if you get third line NHL PIX will be around to cure you the alternative is death with out it!

    The only patients that survived were the ones that took PIX All other patients in the control arms died Period!

    A 24% C/R and a 2 year 65% S/R over any other drug to date is a Good solid drug and should have been passed the first time out!

    Throw Pazdur the thief and Crook out of the FDA!

  • Report this Comment On June 16, 2011, at 4:08 PM, heretosaveus wrote:

    amazing post jonesnj0! please spread your extensive knowledge on the yahoo message board. thanks!

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