News Focus
News Focus
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galexa10

07/26/07 12:05 PM

#7673 RE: neuroinv #7670

<I'll write my Congressman about this. I'm sure he'll get right on it, making sure that the FDA provides the written guarantees that investors need to feel comfortable with their biotech holdings.>

LOL -- you will let us know when you get a response right?
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gfp927z

07/26/07 12:24 PM

#7676 RE: neuroinv #7670

Neuro, "There is no dosing restriction". But that only applies to the PET study. We haven't received any assurances from Neurology that higher dosing will be allowed for longer trials.

When Neurology has completed their review of the tox data, just wondering if you see another separate Cortex press release coming prior to the IND press release, something stating that Neurology has completed their evaluation of the tox data and have officially lifted all dosing restrictions on CX-717? Thanks.




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ruengies3

07/26/07 12:51 PM

#7677 RE: neuroinv #7670

"Hold his breath until he turns blue if Neurology does not state in writing that Cortex can dose for up to three months in a trial they havent even designed yet?"

Do you think that would work?
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ruengies3

07/26/07 12:53 PM

#7678 RE: neuroinv #7670

"I'll write my Congressman about this. I'm sure he'll get right on it, making sure that the FDA provides the written guarantees that investors need to feel comfortable with their biotech holdings."

Thanks, Neuro!
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corwatcher

07/26/07 7:40 PM

#7708 RE: neuroinv #7670

Neuro, help me understand something. It seems that there are those on this board that continue to say there is still a dose limitation on CX717, but also seem to believe that Cortex is in the process of filing a new protocol for another ADHD trial. How and why would Cortex file for a new trial if they could only expect to run the trial with the low dose limitation that was put into place last year (they didn’t want to pursue any trials with the lose dose limitation in place at that time, why now)? The fact that they are putting together a new proposal for an ADHD trial should be evidence that the prior limitation has been lifted. Wouldn’t they be wasting their time and the FDA if they are knowingly submitting a proposal for a trial or trials that ask for dosing that is currently NOT allowed? What am it missing?