1)If Schickler indeed told the Globe reporter ( I certainly hope not) that it would take 3-4 years to submit an NDA, Pharmos needs to buy better consultation regarding trial design and execution. There is no way, IF HU-211 behaves as well as many observers expect, that it should take that long. If the Phase II results are positive (and this does not require .05 statistical significance, with these small cohort sizes, consistent trends plus safety will suffice), that should garner a solid partner. By solid partner, I refer to a company willing/able to start a Phase III before the end of 1Q:99 (they will have to wait for the final cohort to complete in order to select the best dose for the Phase III). With enough sites on board, an 800-1000 pt Ph III could be run in 12-15 months.The greater the relative impact of HU211, the smaller the sample size needed for PhIII (though reducing it too far would risk the kinds of statistical glitches that have plagued Interneuron's stroke trials). With data analysis and NDA preparation taking around 6 months, the NDA should be submitted by the end of 2000...2.5 years from now. There are best-case, more risky scenarios that could accelerate it slightly (e.g. a positive interim analysis), but this is not an unreasonable timeframe which assumes a modest magnitude of therapeutic effect.
NeuroInvestment (www.neuroinv.com)
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