The 50% for Non-Approval

20% right off the top for the fact that the FDA’s Oncology Drug Advisory Committee is one of the hardest regulatory bodies to get a drug through and it is led by a very controversial figure, Dr. Pazdur who has sent more than one promising drug back for clinical trials (Dendreon’s Provenge comes to mind). So be on the lookout for this guy.

20% for the Cardiotoxicity concerns outlined in the latest press release. Cell said that “two cases of congestive heart failure on independent cardiologist assessment were attributed to pixantrone and the follow up study is ongoing.” So there still could be more information out there that will be released, also I am sure the FDA will haggle them with questions about this.
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10% for Cell Therapeutics having a smaller sample size than originally designed. Initially the trial was set to be full of 300+ patients, but after slow enrollment Cell therapeutics spoke with the FDA and the FDA allowed the company to reduce the trial’s size. The trial results now consist of about 140 patients, which is large enough to draw conclusions, but it also gives the FDA the chance to say they aren’t sure if something in the data is a statistical anomaly or actually a cause and effect of the drug. If the FDA does have such a question, the trial’s sample size will definitely become an issue because if there is a problem the FDA might want to see more data in which case another clinical trial would be needed.

I hope this brief analysis was helpful and informative for the readers, if you wish to review and in depth analysis of Pixantrone please visit the “My Drug Analysis Articles” page of my website.

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