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Re: Finn post# 1651

Wednesday, 10/25/2006 9:39:17 AM

Wednesday, October 25, 2006 9:39:17 AM

Post# of 57993
We've had a surprise six months ago. Then Cortex cleaned up its act, met with the FDA, hired consultants, did the proper studies, and the hold was lifted with agreed upon dosages and time frames.

Surprises at this stage would be a bad omen(for me). I just don't see that happening. For if it did, it would signal that Cortex may indeed be powerless to other's agendas at the FDA; in that case it wouldn't matter if CX717 was pure gold. To be honest, I'm unsettled that the road map was not laid out better back in April. A, B, C get out of jail at all dosages card. There was a letter in April detailing the FDA's misgivings. Cortex hired some consultants and did A, B, C and apparently started D last Summer--instead of April.

This may mean that there is one overworked FDA point man dealing with Cortex and 50 other biotech concerns so he's running around in circles. Or it could mean somebody at the FDA has an axe against Cortex or it's role in ADHD, MCI. OR it could mean somebody is getting a nice endowment in a Swiss bank courtesy of a big pharm, or it could mean somebody is working on a job at that big pharm.

But if the reason is as innocent at the FDA being overworked and therefore a wee bit of miscommunication is still occuring, then this is not a totally satisfying explanation either, since it signals more to come vis-a-vis the angst department.

In this setting, I would urge Dr. Stoll to simply detail the exact nature of the initial problem, where it was seen, at what juncture of the preclinical testing, and where it was not seen. With the FDA Yellow Light and heightened anxiety, I think the simple truth is needed. To be honest, I've never really understood the nature of the explanation, "we don't want to give away trade secrets to our competition." How an anomaly in a patent-protected compound of Cortex is giving away the kitchen sink doesn't seem like a full explanation.

Stoll maybe feels another way and may simply gloss over the issues. Fine. But if the Feds continue strong arming tactics in December . . . or if the goal posts are inched down further into the end zone, I think the stock will suffer. I think all of these perceptions can be cleared in a press conference. I don't think any trade secrets would be given away to the competition by doing so. So much for my 8 a.m rant.

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