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enemem

10/26/10 7:06 PM

#34514 RE: bladerunner1717 #34513

That actually sounds believable. The problem is, if the new POC study isn't as robust as the original trial, then they may end up saving money on the trial only to get inconclusive results due to the weaker trial design.

How likely is it that they can get a partner to sign on to foot the bill for the trial prior to an IND submission? What does this do to the up-fronts etc? In order to get the trial done, they may have to defer a decent up-front again.

This company is trapped by its undercapitalization. All the counterparties are going to continue to take advantage of this situation.
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gfp927z

10/26/10 7:35 PM

#34516 RE: bladerunner1717 #34513

Blade, Thanks for the info. Sounds like we should be getting the SA results very soon.


Some backround on the CX-717 ADHD Phase 2A study -

68 patients, with dosing at 200 mg BID and 800 mg BID. A double crossover design, dosing for 3 weeks, then a 2 week washout period, followed by another 3 weeks of dosing. I don't have all my notes, but I remember there being a fair number of dropouts in the 800 mg BID group, but they were still able to demonstrate statistical significance at 800 mg BID. Efficacy-wise, CX-717 showed a similar response at 3 weeks that Strattera took 4-8 weeks to achieve.

With CX-1739, the partner might want to also run a cohort using once/day dosing. Even though CX-1739 has a shorter halflife than CX-717 (approx 7-8 hrs vrs 9-10 hrs), it is approx 3 times more potent (depending on the indication). So generating some once/day data would be useful, though would add to the cost of the trial.
























































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gfp927z

10/26/10 7:48 PM

#34517 RE: bladerunner1717 #34513

Blade, At the May Shareholder's Meeting, Varney said the original CX-717 ADHD study had cost $3.7 mil (according to my notes). That sounded pretty cheap, and I expected a higher figure.



























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davidal66

11/01/10 5:43 PM

#34575 RE: bladerunner1717 #34513

Blade, I would assume Varney's latest missive was from days ago? From the alleged e mail where he said the following

"We remain on target to have data by the end of October for the sleep apnea.

Regards,

Mark"

My comment. Why bother making predictions you have not kept, you are not keeping and will not keep? Maybe I'm being overly harsh because I'm irritated with this relatively small issue of missing a deadline/prediction by a day or so, but days add up. From topline results by mid '09 to the end of October 2010.

Wouldn't it be more prudent to not commit statements to email or audio that are not based on fact? Or, to be more generous, give yourself some wiggle room. Something along the line at "around the end of October, give or take a few weeks."