JAV
"What I don't understand is why they can't accelerate the schedule for the PK studies and the eventual filing"
This question was asked. The answer is they could if they wanted to, but they are limited by manufacturing/stability requirements for the filing, so there is no point to accelerating the pK studies..they'll pace the pK studies so the entire data package is complete for a filing
"the interesting thing about JAV is that in the intranasal ketamine they already have a product that is--for all intents and purposes--approved. At least if you take Carr's statement at face value that the PK studies are just for labeling"
this point i did not fully appreciate until the cc. i knew more efficacy testing was not required, but i still thought they had to show reliable pk characteristics for approval..apparently this is also NOT the case. carr said basically they are sitting on proprietary pK data already, and intimated this is sufficient for approval, and all that is needed now is interaction data, e.g. do requirements change for pts on intranasal allergy meds (kind of like examining food interaction with PO meds). so indeed, ketamine does seem like a done deal, and the only real issue is how much commercial potential the drug has
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