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Sunday, September 24, 2006 3:17:38 PM
Regarding your first question: -- the negotiations are a 'black hole.' They could take a few months, maybe six months? Who knows. Stoll says they will file an IND and start phase IIb. I personally don't think they will wait until the phase IIb results come in. Remember--it will take two, possibly three phase IIb results to arrive at the correct dose for phase III(and complicated pediatric safety work needs to be done). So while strong phase IIb results up the ante a bit--since such results will not, in and of themselves) place CX717 on the cusp of phase III, I would strongly expect a deal while the trial is ongoing. If the trial starts in late November, early December, enrolls 100 patients over eight weeks with washouts pre and post, it might conclude enrollment in April of '06 with another 9 weeks to get all the patients through their paces--July '07 with data analysis in August? I doubt Cortex wants to wait that long since a large pharma could move in earnest in these directions at once. So, why start the phase IIb ADHD trial as well? Why not? It will save a bit of time off the whole process for one.
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