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bladerunner1717

10/26/06 5:39 PM

#1704 RE: Aiming4 #1701

aiming,

The problem isn't only whether the cellular problem will show up in the longer-term studies--and gfp is right when he says it probably will, given the dosages--but, rather, even if the longer-term studies are clean toxicology-wise (and even clean cellular-wise), COR has no explanation as to why the histopath abnormalities came up in the first place. Wth COR having to present this data to a new division in the FDA, if they want to proceed in ADHD, there is no guarantee that even "clean" findings will be enough to get the FDA to approve further, longer-term studies with CX717. I'd say CX717 is toast in ADHD. And, of course, that includes any hopes of partnering anytime soon.

We'll be lucky if we don't get more than a 50% haircut tomorrow, and that means the financing will have to be done at the $1.25/1.50 range. Not a pleasant thought.


This is really a disaster. And Stoll's downbeat assessment--what else could he say?--confirms that view. Even his rosy interpretation at the end cannot overcome seeing this for what it really is.


Bladerunner




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gfp927z

10/26/06 5:46 PM

#1707 RE: Aiming4 #1701

Aiming, Yes, and a bigger concern is Org-24448. I'll have to re-listen to the presentation, but while Dr. Stoll seemed to suggest that he didn't think this cellular problem has been noted in Org-24448, I'm not going to assume that yet. If they do tox trials on Org-24448 specifically looking for the same type cellular changes, who knows what they might turn up at really high doses. Up to recently, Ampakine dose levels in animal tox trials have been limited by nausea/emesis problems. Cortex was able to boost the levels considerably in doing the recent repeat studies. Who knows what doses they originally used with Org-24448 (probably lower than what can now be done). Dr. Stoll said the histologists hadn't even seen cellular changes of this type previously, so they're not familiar with what the hell might be causing them. The technology is brand new so there is no framework by which to evaluate the cellular phenomenon.

What Cortex needs to do now is do massive tox work-ups on both CX-701 and the other backup, and see if the cellular changes happen again. If they don't, we have a huge setback but the low impact platform has a future. If the do, the entire low impact platform could be history.