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asuhowe

03/07/08 9:30 AM

#15869 RE: gfp927z #15868

true, but, it sure beats the alternative press release we come accustomed to.
however, I don't think it's going to do squat for the pps.. ; (
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Aiming4

03/07/08 9:38 AM

#15870 RE: gfp927z #15868

Gfp - I agree that if the additional approval applies to both trials, then the PR should have been worded more clearly.

But either way, I think the PR does convey the more important fact that the use of CX717 has been approved.

One would expect that the approval to use opiates in the trials is just a formality.

So other than the wording, I applaud Cortex for putting out a PR that has good and significant news for the company's shareholders - it may help prop up the pps until the final opiate use green light is given.
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neuroinv

03/07/08 9:43 AM

#15871 RE: gfp927z #15868

Gfp: You must have received a different press release. Where did the PR say the trial "is starting?" It didn't; it said Cortex has "received approval from the German Federal Institute For Drugs And Medical Devices". The other sign-off they mention is from the German equivalent of the DEA, which has to OK the use of an opioid drug. In other words, there is no regulatory step left for CX717, just for the use of fentanyl. And I think that, to borrow a phrase, is a....sssslll....OK I'm not going to tempt fate by writing the SD phrase. But it is.

Given the complaints oft-cited about Cortex not 'tooting its own horn', it seems strange to criticize them for saying something they did not actually say, when they are actually putting this out there in an appropriately upbeat fashion. Personally--I had said that I would be nervous until the trial actually received the go-ahead. I am no longer nervous about this, it will happen.

It's only going to take a few patients for Cortex to know whether CX717 actually works in RD. Even though the trial is blinded, all you need is one or two subjects who don't go into RD when hit with enough fentanyl to slow a rhino, and the investigators will call Irvine--actually, I expect someone from Cortex will be there watching...I would be.

So the dataset will be complete late in 2Q: but by mid-April, I'll be trying to read the mood at Cortex. If they're smiling and using words like "excellent"---we'll know.

NeuroInvestment