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moosedogger

10/25/06 10:34 AM

#1659 RE: davidal66 #1658

Thanks for sharing all the additional detail/background.

I agree with you that the more Stoll can tell us the better, as long as he doesn't give away COR's secrets in doing so.

Looks like a difficult, "high wire" act to me.

Hopefully, we'll all know a lot more Thursday.

I'm sure we all share your anxiety re this mystery.

Thanks again for illuminating your thinking on this.
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gfp927z

10/25/06 11:44 AM

#1661 RE: davidal66 #1658

Daviddal, Dr. Stoll may not give much additional info on the nature of the original histo finding, though I'd like a confirmation that it was seen in primates (I don't remember this being officially revealed, unless I missed it).

Some topics for the conf call include -

1) Details of the dose level restrictions.

2) Are there dosing duration restrictions also (specifically, is 3 week dosing allowed and at what dose?).

3) Did the new acute data that Cortex sent to the FDA appear clean (no apparent repeat of the histo finding)?

4) Was the current 3 month tox study in primates requested by the FDA, or was it a preemptive "just in case" suggestion by Cortex's consultants?

5) Is there any assurance from the FDA that getting clean 3 month primate tox data will remove the dosing restrictions?

6) Likewise, can we reasonably expect clean 3 month primate tox data to allow future 3 month human trials to proceed?