It largely depends on whether the FDA grants expedited status. This is not a directly life-threatening situation (though Neurex will make the point to the FDA that unbearable, untreatable pain indirectly is life-threatening via suicide, physician assisted or not, and debilitates already desperately ill patients (in the malignant pain group). If they file the NDA mid-year and are granted expedited status, that infers action within six months. I think they have better than 50/50 chances of this, but it is far from certain. I would not be surprised to see an Advisory Panel before year end, and even if the sixmonth window is exceeded, approval by the end of 1Q:99 seems reasonable. This is slightly less conservative than your estimate. A very optimistic observer might raise the question of whether an AP will be required, since safety concerns do not seem salient, efficacy looks clearcut, and there is no tx for neuropathic pain at present. The one unknown is how much duration of use data they will need....a chronic use study is already enrolling, and the FDA will pull data from that through the review process. Best case scenario is Christmas 1998...conservative is March 99, worst case is end of summer 1999.
NeuroInvestment |
