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Biotech / Medical : Neurex Corporation
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To: John McCarthy who wrote (381)1/13/1998 7:18:00 PM
From: NeuroInvestment  Read Replies (2) of 449
 
Phase III patient accrual is done for the neuropathic and malignant pain trials. The interim analyses (the first, for neuropathic pain, reported on today) had been built in to ensure that they had indeed accrued a sufficiently large n that the effect would be statistically significant. As it turns out, their sample appears to have been 2-3 times larger than they needed given the strong magnitude of effect. They have not yet conducted the interim analysis on the malignant pain group, but that indication has a strong database already, I expect no problem there. This was a strong showing for ziconotide, particularly given indications that the non-ziconotide group showed no improvement at all (very little placebo effect, and no evidence that patient improvement came from a 'fine-tuning' of the alternate, usually opioid regimen available to all patients...) The NDA will not be filed before mid-year. NeuroInvestment
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