Earlier in the week biotech drug developer Neurocrine Biosciences
Neurocrine had a rough time last year with indiplon. The drug received an approvable letter for two of the three dosage strengths for which the company was seeking approval, but a non-approvable letter for a more marketable dose of the drug. Following the negative regulatory decision, Pfizer
Thirteen months after the approvable letter letdown, Neurocrine has finally resubmitted a marketing application for the two lower doses of the drug. This resubmission follows discussion with the FDA and the decision to forgo more clinical studies on the drug.
An FDA regulatory decision on indiplon should arrive approximately six months from now if the FDA grants it a class 2 review. The agency does this when a drugmaker submits more clinical trial data, like Neurocrine was asked to do.
If Neurocrine gets indiplon through the FDA it will still have to decide whether to market the drug itself, which will rapidly drain its $166 million cash and investments stockpile, or to find a partner for the very competitive and expensive insomnia market.
Having to make this type of decision is something Neurocrine investors wouldn't mind, though. While they wait for a decision on indiplon, investors will be treated to updates on the rest of Neurocrine's pipeline over the next twelve months.
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