Tuesday, July 17, 2007 11:00:07 AM
A few points:
1) Cortex had an original protocol submitted to Neurology for AD which went up to 1200mg per day. Based on their preclinical data, that's what they thought they needed. There is/was no agenda to go beyond that in AD. And no reason to ask for something you don't really want.
2) Do they need to go beyond the 1200mg dose for ADHD? You don't just add 800 and 800 together to equal 1600mg. While the question gets more complicated if there are metabolites with different half-lives and weird pharmacokinetic curves, the question is more likely to be one of maximum blood-level. If I recall correctly, CX717 is supposed to have a half-life in the 8-9 hour range. Which means that (oversimplifying) at 8 hours, half of the drug has been metabolized, out of the system, no longer bioactive in the brain. If one gives a second dose at that point, one must also wait for it to ramp up its action, even as the first dose continues to dissipate. Thus--again oversimplified, I don't know what the pk curves are--the maximum blood level from two 800 mg doses spaced 8hours apart might never exceed the maximum dose level achieved from a single 800mg dose. Besides, they are hoping that they can get CX717 to be a once-daily drug, though that might require a time release element, 8-9 hours is not quite long enough, though it would get a kid through a school day.
3) Why do I consider ADHD more important than AD? I have never emphasized the AD indication for CX717. The high-impacts are more likely to be useful there due to neurotrophic effects. But the low-impacts are ideal for ADHD and schizophrenia. And while Dew may disagree, I think there is a rich market available to a nonstimulant that works, especially if it works with hyperactive behavior as well as inattentiveness, and CX717 did both in Phase IIa.
4) Blade. Price targets? I hate price targets, mainly because mine are so often wrong, and because they are influenced by extraneous factors (suicide bombers, mortgage rates, Presidential incom--whoops, almost got into trouble there--but you get the point). I published 8. Does that mean it couldn't get to 12? No. But I am practicing being grateful for good things, and given that Cortex was at 1 and change early this year, 8 would be something to be grateful for.
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