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I agree that they are showing some signs of life. In addition to the strong gains in modified EBIDTA they just announced a small new contract from Germantown, TN. Former Rep. Harold Ford, Sr. (Tenn.) should help nail down a few more of those in the coming months. Cost savings plus new contracts is the way to profitability and we've just made a few baby steps in the right direction.
Good Luck!
Fritz
>>>>Thanks Fred, I was looking at the article in #Msg-23231504 which was more generic about the causes:<<<<
No problem, Aiming. I actually read the full version earlier today and I was alarmed when you asked me for a citation and I couldn't find the mention of RD that I was sure I had seen earlier. LOL
So, is this an indication of a potential partnership or just a pipedream of mine?
-Fritz
RD is mentioned 3 times in the Ceph press release. While they didn't say exactly how 3 of the 4 patients died (one apparently was a suicide) it sure points in the direction of RD.
-Fritz
============================================================
News Releases 2007 2006 2005 2004 2003 2002 2001
Media Kits
On The Record
News Release
Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
09/13/2007
FRAZER, Pa., Sept. 13 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today communicated with healthcare professionals to clarify the appropriate patient selection, dosing and administration for FENTORA(R) (fentanyl buccal tablet) [C-II]. The company is sharing this information with the medical community to reinforce the appropriate prescribing and use of the medication.
The letter, issued in collaboration with the U.S. Food and Drug Administration (FDA), was in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for FENTORA. These events appear to have occurred as a result of improper use in patients who were not already taking opioids around-the-clock (opioid nontolerant); improper dosing of the medication; and/or improper substitution of FENTORA for other fentanyl-based medications.
The letter has been sent to physicians, pharmacists, managed care organizations, and other healthcare professionals and it emphasizes the need to adhere to the FENTORA prescribing information, including the following:
* FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
* FENTORA must only be prescribed to patients who are routinely taking around-the-clock opioids. FENTORA should not be prescribed to patients for acute pain, postoperative pain, headache/migraine, or sports injuries.
* Only one tablet per episode should be taken once a dose is established and patients must wait at least four hours before taking another dose of FENTORA.
* FENTORA is not bioequivalent to or a generic version of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]; therefore, FENTORA should not be substituted for ACTIQ or any other fentanyl-containing pain medication.
Cephalon also is proactively working with the FDA to emphasize the appropriate patient selection, dosing and administration in the FENTORA label and Risk Minimization Action Plan (RiskMAP). Healthcare professionals and patients may contact Cephalon Medical Services at 1-800-895-5855 or visit www.fentora.com for additional prescribing information.
PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE
IMPORTANT WARNINGS IN THIS LABEL.
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the
highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid nontolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children. (See Information for Patients and Caregivers for disposal instructions.)
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg per mcg basis. Adjust doses as appropriate. (See DOSAGE AND ADMINISTRATION.)
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
Full prescribing information about FENTORA, including boxed warning, is available from www.FENTORA.com.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently inducted in to the World Economic Forum Community of Global Growth Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered a seven-year compound annual growth rate (CAGR) through 2006 greater than 75% and 2006 revenue of $1.760 billion. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV), FENTORA, TRISENOX(R) (arsenic trioxide) injection, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products,; interpretation of clinical results; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward- looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE Cephalon, Inc.
I also read this development today with interest. This is a RD problem for Cephalon. I wonder who could help them out on this issue? Hmmm.....
OT: GFP
<<<My main problem continues to be -- too many stocks to follow, and not enough money yet to properly diversify.>>>
Yes I understand these problems, i.e. time and money are both limited. However, HALO, is a special case. Their technology is largely already through the FDA gantlet and all that remains is making deals for income streams from BP companies. They've already partnered up with Baxter and Roche for a relatively small amount of products. E.g., with Roche it was a deal involving about a dozen of Roche's compounds. HALO platform is potentially useful in about a THOUSAND drug products. (That's not my estimate - it's HALO mgt. talking!) Moreover, they are anything but cash poor at the moment so dilution is not on the horizon and should never be an issue again. This is not going to change unless management gets really stupid all of a sudden. (Not at all likely.)
It's been said that HALO is on the third floor of a hundred story elevator ride. I see no reason to disagree. I'm not in the business of touting stocks, and HALO is not going to benefit one way or the other from my voice in the wilderness, but in response to your question about any new MSFTs on the horizon, I'd say this is it, IMHO.
Regards,
G
GFP:
Halozyme Therapeutics (HALO) is $$$ in the bank. Much less speculative than COR. HALO is my core holding. Unlike COR, I've never lost a minute's sleep over HALO and it's not too late to get in. Randall Kirk just recently took his NRPH winnings and moved a bunch of it over to HALO.
He's now on the BOD there so you don't have to just take my word for it
-Fritz
Chartman:
HALO: $$ in the bank
looking now - Thanks!
Well, you've certainly been right so far!
Keep 'em coming!
-Fred
Perhaps you could favor us with an explantion as to what is the reason for the run?
Congrats on the good call.
Good luck!
G
Question for COR oldtimers.
We've debated the recent PIPE and pps meltdown and all sides have made their feelings known. I've seen Dr. Stoll's leadership questioned and debated. However, the main question for me right now is whether he has at any time in the past thrown a curve to shareholders. What I'm driving at is whether he has misled folks with reassuring words one day and them hit them in the gut shortly thereafter? This is a key point in assessing the value of his recent emails assuring us the all is well and not to worry. Can his comments be taken at face value in your experience?
Thanks!
-Fritz
What is the basis for the recent move?
No news as far as I can tell.
-Fritz
In the long run, we will be dead. Sorry Neuro, had to take that opening:=)
In the long run I'd rather be in Philadelphia (watching the Iggles).
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)