The never-ending stream of bad news continues for drug developer Neurochem
Neurochem first received an approvable letter for Kiacta last August, with a request from the FDA to provide more safety information and run another efficacy study on the drug. Rather than heed that request, the company filed an approvable letter response two months later, sans another efficacy study. The drug was originally set to get an FDA review in April, but the review was delayed by Neurochem's submission of more data on the compound in February.
Either out of stubbornness or incompetence, Neurochem mentioned in the press release yesterday that it would be filing another response to the FDA "in the near future" in the hopes of rectifying the approvable letter concerns and getting Kiacta approved for marketing. Since it will have completed no new studies of the drug and is only testing the compound in its ongoing open label phase 2/3 extension study, it's unclear what new data Neurochem will include in this upcoming approvable letter response.
Considering that the FDA once again asked for more clinical trial work, it's highly unlikely that a third attempt at gaining approval for Kiacta will be successful without these requested additional studies. As other drugmakers have learned recently, ignoring the FDA's requests for more data doesn't tend to work out in their favor.
It's hard to find a drug developer, besides Telik
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
