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Biotech / Medical : Neurex Corporation -- Ignore unavailable to you. Want to Upgrade?


To: John McCarthy who wrote (394)1/15/1998 9:09:00 AM
From: NeuroInvestment  Read Replies (2) | Respond to of 449
 
1)Keep in mind that this was an interim analysis, the company remained blinded (it was carried out by a 3rd party). If there was such a high dropout rate that one might run into treatable vs evaluable sample power issues, Neurex had the option to simply continue accruing patients (at the lower start dose where the dropout rate has been 15%). While the market would have been disappointed, it would be nothing compared to what it would mean to run into a FDA snafu down the road. Neurex and the FDA have been on the same page throughout this process (unlike some neuro companies we could all name). Unless you believe that Goddard et al have a death wish, I believe it is safe to assume that if there was a treatable/evaluable discrepancy that put the study stats (as agreed upon with the FDA) at risk, they would have simply resumed accrual.
2) If you want something genuine to worry about, look for the release of the neuropathic pain Phase II data from the Neurobiological Technologies memantine trial, due out late Jan/early Feb. While I expect memantine to have less magnitude of effect, it is given orally and thus is a lot cheaper and easier to utilize. If successful, NTI would push a Phase III partnership ASAP, since they are near bankrupt.It could be a competitor for the mild-moderate range of neuropathic pain patients. NeuroInvestment