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Re: IND filing:
Someone posted this Rodman and Renshaw analyst report on YH. I have no idea if it's legit but it clearly states that the psychiatric IND has been file and an FDA response is due by the end of Sept.
I'll paste it below for your consideration.
================================================================
RODMAN & RENSHAW
August 22, 2007
TOP PICKS
Cortex Pharmaceuticals, Inc. (COR)
Price: $2.62 (8/21/07), Market Cap: $105MM (8/21/07)
Rating: Market Outperform; Target Price: $4.50
THE COMPANY
Cortex is developing AMPAKINE compounds for the treatment of Alzheimer’s disease, mild cognitive impairment,
Parkinson’s disease, attention deficit hyperactivity disorder (ADHD), schizophrenia, depression, and others neurological
diseases. Cortex’s lead compound CX717 has completed a Phase II trial in ADHD. The firm announced positive data
for CX717, which showed efficacy comparable to one of the marketed drugs (Strattera) along with a superior safety
profile. In April, the FDA placed a clinical hold on CX717 due to concerns over certain tissue abnormalities at cellular
levels observed in a 13-week primate study. When Cortex submitted data from a 2-week rat study as part of the
response to the clinical hold, this tissue abnormality was again observed. While previously running clinical trials with
CX717 are permitted to resume, the FDA remains concerned regarding certain findings at the tissue level and will not
permit additional studies to be performed with CX717 at dosing levels suitable for the ADHD indication at this time.
Cortex has completed additional animal studies indicating that the tissue abnormality previously seen is not due to any
toxic effect of CX717. The firm has submitted this data to the FDA; the Neurology Products Division removed the dosing
restrictions on CX717 for the ongoing Alzheimer’s disease study in July. Cortex aims to start a Phase IIb study in 2H07
with CX717 in ADHD, pending the acceptance of an IND including the request to test higher doses of CX717. This IND
has been submitted to the FDA’s Psychiatric Products Division and Cortex expects a decision in September 2007. In
addition to CX717, Cortex has a large collection of AMPAKINE compounds and has out-licensed some of these to
Organon for the treatment of schizophrenia and depression.
KEY CATALYSTS
• FDA Psychiatric Products Division acceptance of IND for Phase IIb trial of CX717 in ADHD by end-September 2007
• Start of Phase IIb study in ADHD with CX717 in 2H07
• Partnership on CX717 for ADHD, potentially by end-07
FINANCIALS
Cash (pro forma) $11MM
Burn in next 12 months $16MM
==============================================================
We'll know soon enough if this info is correct.
Good luck to us all. We need it!
-Fritz
Part 3 of the LA Times series on Dr. Lynch:
http://www.latimes.com/news/nationworld/nation/la-na-memorythird21aug21,0,6245862.story?coll=la-home...
Money:
Too bad you didn't post that on Monday during trading hours. We coulda made a fortune LOL!
:=)Fritz
<<<<Pharmacological enhancement of glutamatergic neurotransmission through AMPA receptors may have potential for therapeutic utility in the treatment of Pharmacological enhancement of glutamatergic neurotransmission through AMPA receptors may have potential for therapeutic utility in the treatment of tinea cruris.>>>>>
American Heritage Dictionary - Cite This Source
jock itch
n. A fungal infection of the skin of the groin area, occurring more commonly in warm weather and among males and characterized by red ringlike areas, sometimes with small blisters, and severe itching; ringworm of the groin. Also called tinea cruris.
The American Heritage® Dictionary of the English Language, Fourth Edition
Copyright © 2006 by Houghton Mifflin Company.
Published by Houghton Mifflin Company. All rights reserved.
tinea cruris
noun
fungal infection of the groin (most common in men)
WordNet® 3.0, © 2006 by Princeton University.
American Heritage Stedman's Medical Dictionary
tinea cru·ris (krrs)
n.
A fungal infection of the skin of the groin, occurring especially in males. Also called eczema marginatum, jock itch.
The American Heritage® Stedman's Medical Dictionary
Copyright © 2002, 2001, 1995 by Houghton Mifflin Company. Published by Houghton Mifflin Company.
Merriam-Webster's Medical Dictionary
Main Entry: tinea cru·ris
Pronunciation: -'krur-&s
Function: noun
: a fungal infection involving especially the groin and perineum
Merriam-Webster's Medical Dictionary, © 2002 Merriam-Webster, Inc.
Jeeesh!, Finn!
"Get thee to a nunnery."
(Thought quoting some Shakespeare might elevate the class level around here for ya.)
-Fritz
>>>Paris is out of Jail...she could seductively announce the filing of the IND doing a strip tease with her new clothing line!<<<
She certainly does have a certain level of expertise when it comes to pharmacologicals.
Still, I'd go with Erin's youthful exuberance.
-Fritz
I'm short Maria and long Erin :)
-Fred
I recognize the superficial cut and paste nature of this analysis, but are there factual inaccuracies that I'm not seeing?
Thanks,
Fred
Thanks, Dew:
You exposed my ADHD reading skills once again. LOL!
-Fred
Thanks, Blade,
Maybe TheStreet is just playing dirty with an innocent "typo".
There's likely to be a bit of piling on by the big boys to drive the pps into the dirt, like we saw with GNVC, so this may just be the opening shot...
Fred
OT..IDIX cash on hand
I've seen various claims that IDIX has $160 mil in cash but according to thestreet.com
>>>Despite the discontinuation of the development of valopicitabine, the company said it still expects to end 2007 with $100 million to $110 million of cash, cash equivalents and marketable securities.<<<
What am I missing?
Thanks
Fred
Cash on hand...
According to TheStreet.com:
>>Despite the discontinuation of the development of valopicitabine, the company said it still expects to end 2007 with $100 million to $110 million of cash, cash equivalents and marketable securities.<<
Divide that by 60m and you get less than $2 per share. Dew: what am I missing?
Thanks,
Fred
Might be a good time to get in. I had my head handed to me when they disclosed that problem with particulates in the production batches a few months ago. Got out then and frankly haven't returned for a new look. Have they come up with a new partner to do the commercial production?
-Fred
PGS:
I use Firefox but I, too have those complex five dollar words double underlined with a handy definition of, e.g., "profits" at my fingertips.
Good thing I can always read up on it because I've got no personal experience from which to draw any knowledge.
Fred
Re: Dr. Stoll's alleged comments.
Not too long ago I was playing with some pink sheet stocks and hanging around the relevant MB's in that arena. It was not uncommon to have someone post there an alleged quote from an officer of the company in question regarding a pending material event. Needless to say that it became apparent to me and most other investors in the pink sheet company that these private "communiques" which were so generously shared with fellow investors, turned out to be made up from whole cloth by the person doing the sharing. The money I lost in those ventures was what I now consider part of my "tuition" paid to the Individual Investors' School of Hard Knocks. The lessons in that school are costly but valuable.
As a result, you'll forgive me if I am a bit skeptical as to the veracity of these types of postings. I have occasionally written to
IR reps of a given company and have never received a personal reply from the CEO or anyone of similar stature. Take these postings with a grain of salt.
PS.:Someone named "atheroprevent" posted this same msg containing Dr. Stoll's "reply" on the Yahoo MB and was excoriated for it by another skeptic who used far less delicate language than I am here. LOL
Being employed as a bureaucrat in my own right I can tell you that I would have been much more inclined to pitch into a 3 foot box. Six foot boxes are very heavy, represent a ton of work, and usually lay where the deliveryman drops them for a long time, until someone in authority decides that it can't be ignored anymore. Moreover, it's vacation time, so big projects without hard deadlines can just as well wait until September...
(Damn! wish I'd thought of this before plunking down all that cash on cortex!) :(
Only a few hundred shares. Don't get too excited :)
Still, here'shoping for a green Monday.
Freddy
Dew:
What, in your opinion, is the functional source of the phenomenon of program survival bias?
Is it as simple as the lack of double blind controls?
Thanks,
Fred
750,000 shares moved, snap!, just like that!
Is the FDA info system really that porous???
Sure looks like somebody knows something.
Good luck to us all!
Freddy
Thanks, GFP.
Still holding my breath.....
In your experience would any announcement orccur intra-day or do they traditionally wait til the closing bell?
Good luck in any event.!
Horselover:
The Sens are going to re-group and we will be treated to a 7 game series, so if the Cup hoisting and FDA decision are co-terminus events then we have another week of waiting. Meantime we can distract ourselves with he best hockey games one can hope to see.
-Fred
Yes, I took the plunge and got in at $2.77.
I consider this my most speculative play, but I've learned a lot from you learned and generous folks here.
FYI I'm long on HALO (formerly HTI) which I consider safe as a T-Bill. Also, very heavy into GNVC which has an outstanding pipeline. My sleeper is NRGX, which is a longer horizon play than the others, but somebody with deep pockets has just finished an astounding round of accumulation there over the last 6 weeks or so, driving the price from 60 cents to $1.14 or thereabouts.
Good luck to all and Go Eagles!
-Fred (Gophred on Yahoo MB)
Another Iggles fan here.
I believe Buddy Ryan called the run and shoot offense the "Chuck and Duck offense". LOL!
There is a fine book on Coley and his work.
"A Commotion in the Blood", by Stephen S. Hall.
Very readable biography.
Rod
I'm with you all the way on your analysis. I posted as much on Yahoo that I think Kirk's past history of accepting a buyout for New Riveris no indication of his plans here with HALO. Current management as well as Mr. Kirk are not out for a quick buck and most certainly understand more than all of us that they are in possession of a cash machine. I seriously doubt that the main players at HALO will kill the golden goose.
By the way, the Yahoo folks are still active over there and would miss your input if you don't post from time to time.
Good Luck and Best Wishes,
G
(gophred on Yahoo)
Thanks,
That makes sense, of course!
Good Luck and best wishes,
Fred
Insiders.....
Hi, all:
I've been engaging in DD with a view to possible investment in COR.
The science is intriguing (to this layman at least). The potential market is huge. The pipeline is pretty substantial. Burn rate seems to be within responsible limits. The one thing that sticks in my craw at the moment is the distinct lack of insider commitment. Any comments on this topic would be most appreciated.
Best Wishes and Good luck!
Thanks, I think I finally understand it!
-Fritz
Hi, Folks,
New here and new to pink sheets.
I'm confused over the issue of the dividend. Exactly what was the issue that got everybody up in arms?
Was that concern addressed by the company to everyone's satisfaction?
Thanks for your input.
-Fritz
WASHINGTON (Dow Jones)--Metrologic Instruments Inc. (MTLG) said Thursday that two shareholder suits were filed against the company last week alleging breach of fiduciary duty.
The company said in a filing with the Securities and Exchange Commission that the suits relate to the merger of its unit Adaptive Optics Associates Inc. with Essex Corp. (KEYW).
The complaints seek a halt to the merger, certification as a class action and certain forms of relief, including damages.
Metrologic Instruments said in its SEC filing that it believes both complaints are without merit and that it intends to vigorously contest them.
As reported Wednesday, Essex, of Columbia, Md., will pay $40.25 million in cash for Adaptive Optics Associates, which designs and makes high-performance electro-optic products and systems.
One lawsuit, filed Sept. 13 in the state Superior Court in Camden County, N.J., alleges, among other things, that "certain defendants have timed and structured the transaction to allow themselves to capture the benefits of the company's future potential without paying fair consideration to the company's public shareholders," according to Thursday's SEC filing.
The other lawsuit, filed Sept. 14 with the chancery division of the New Jersey court, alleges that the terms of the merger were determined without adequate investigation of strategic alternatives, the filing said.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com
(END) Dow Jones Newswires
September 21, 2006 17:02 ET (21:02 GMT)
Copyright (c) 2006 Dow Jones & Company, Inc.- - 05 02 PM EDT 09-21-06