<<Dr. Stoll also mentioned during his presentation that the FDA had just issued a notice that will require that all current manufacturers of ADHD drugs issue Patient Medication Guides that spell out the risks of the current medications with respect to cardiovascular and psychiatric adverse events observed with the currently approved therapies.>>
Obvious new and unprecendented guidlines have been set forth making our liklihood of proceeding through psych an unlikely one unless of course Stoll knew of and did address all new variables set forth. His awareness, although suspect, does unfortunately point us to a paranoind psych division theory. A no win situation which was probably to late to be avoided. The hold killed our AD/BP interest, financing could have been done at higher levels with tight windows therefore unprobable, and confidence of a post mortem artifact forced Stoll to push forward. Neurology approval certainly verified his confidence. But then, the pipe/financing being done at poor terms does show uncertainty. This creates doubt as to how confident Stoll really was.
<<Stoll noted that the potential for a new therapeutic approach to the treatment of ADHD is clear>>
If clear there should be no excuse for mistakes or underprepared data.
<<Dr. Stoll reiterated that the 3-week study in adult ADHD patients randomized to either CX717 or placebo, in a cross-over design, was both clinically and statistically significant on both decreasing hyperactivity and increasing attention on the primary ADHD rating scale which is the primary measure by which all ADHD products are approved.>>
Again, if true, pointing to a paranoid psych theory.
<<The remaining topics covered by Dr. Stoll included an update on the low-impact Ampakine CX701 which Cortex anticipates commencing clinical trials by July 2007, the likelihood of a new research and development collaboration for its high-impact Ampakine compounds, and the in-licensing of a new Phase II non- Ampakine orphan drug.>>
It appears inlicensing will undoubtedly be part of the conference call as a short tem cash solution.
