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gfp927z

10/10/06 10:03 AM

#1411 RE: davidal66 #1408

Daviddal, With the FDA, some of what we perceive as bias/malice might only be the lack of resources/funding and general incompetence. Government agencies are screwed up on many levels. CYA/butt covering is also a big factor at the FDA, more than usual.

At least the partial lift of the hold indicates that the data we did send the FDA was clean. I'm still curious as to what the nature of the acute histo "finding" was, tissue type, etc. Perhaps Dr. Stoll can now discuss it in more detail. It'll also be interesting to get the particulars on the dose limitations. At the least, it's probably safe to assume that a relatively high dose/longer duration ADHD Phase 2b won't be allowed until after the dosing limitations are removed.