Explore small cap ideas before they hit the headlines.
Explore small cap ideas before they hit the headlines.
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As part of a broader Obama administration transparency push, the FDA has announced it's going to start offering the public detailed explanations when it rejects a drug or asks a company for more studies. The agency is doing everything it can to improve public health by explaining its decision-making process, while continuing to protect patient confidentiality and industry trade secrets, Riley says. In the past, the FDA would tell a company exactly what was wrong with its application, but that information was confidential, and drug makers could release as much or as little detail as they wanted. "That can lead to a lot of deception," Roy says. "Companies will sometimes say, 'Oh yeah, everything's cool, we just have to dot some i's,' when what the FDA has actually said is, 'You guys are lying punks and we don't want anything to do with your drug,'" he says. Providing an explanation for a rejection will give investors a clear understanding of whether a drug maker has hit a minor snag or a major obstacle, he says.
Read more: 10 Things the FDA Won't Tell You - SmartMoney.com http://www.smartmoney.com/spending/rip-offs/10-things-the-fda-wont-tell-you-1296257904253/#ixzz1ICgNrnYl
rusbrn.
Drugs stops Parkinson's in rats but is years away in humans
By Jeff Ostrowski • Cox Newspapers www.STLtoday.com | Posted: Saturday, February 12, 2011 12:05 am | No Comments Po
JUPITER, Fla. -- Scientists at Scripps Florida have discovered a way to stop the progress of Parkinson's disease, the brain disorder that afflicts about 1 million Americans and has defied the search for a cure.
Scripps researchers gave mice and rats a pill that successfully stalled the disease's march. In two articles published this week in the journal ACS Chemical Neuroscience, the scientists say they've found a molecule that blocks the enzyme JNK from killing neurons in rodents with Parkinson's.
The drug doesn't reverse the damage of Parkinson's, said Philip LoGrasso, leader of the Scripps Florida team that conducted the research, but it could be "a major breakthrough" for Parkinson's patients.
''It won't cure them," LoGrasso said. "But they would begin taking it and hopefully the disease wouldn't get any worse."
The drug might not be given to humans for years, if ever. But if this invented-in-Jupiter pill finds its way to pharmacies, its success would provide both financial and psychic payback for the $579 million that state and local taxpayers spent to set up the Scripps Florida labs here.
The treatment would be the first to protect the brain from the ravages of Parkinson's. Commonly prescribed drugs -- including levodopa and so-called MAO-B inhibitors -- counteract Parkinson's without slowing it.
''Everything available treats symptoms but doesn't prevent neurodegeneration," LoGrasso said.
Parkinson's is a degenerative neurological disorder that hampers the brain's ability to produce dopamine. Symptoms include tremors, slow movement and balance problems.
Parkinson's strikes 1 percent of people over 60, according to the Michael J. Fox Foundation. Boxing great Muhammad Ali and actor Michael J. Fox are two prominent victims of the disease.
LoGrasso's team conducted its research with a $7.6 million grant from the National Institutes of Health.
In mice, Scripps' drug -- known as SR-3306 -- protected 72 percent of dopamine-producing neurons. In rats, the compound saved only 30 percent of neurons, but even that level of protection reduced rats' motor dysfunction by 90 percent, Scripps scientists said.
Now that they've determined SR-3306 works, scientists must test it for side effects. Scripps researchers will begin a year of toxicology testing in animals after they receive their next round of federal funding in July, LoGrasso said.
If those studies go well, the next step would be tests in humans. Parkinson's experts caution that what works for rodents won't necessarily succeed in humans.
''The animal models for Parkinson's disease don't always translate into humans -- different species, different brains," said Sami Fam, an analyst at Decision Resources, a drug research firm in Burlington, Mass.
But, he said, Scripps Florida's findings are promising.
''A true neuroprotectant would be a blockbuster," Fam said. "If you could give a drug that protects the neurons in the brain from dying, then that would be great."
Americans spend about $1 billion a year on Parkinson's drugs. Because levodopa is available in generic form, it's inexpensive, Fam said. However, levodopa tends to work for only a few years, so doctors try to delay using it.
LoGrasso said he has talked to private companies about commercializing the Parkinson's treatment, but he wouldn't offer details.
If the drug works in humans, it would be a boon both for Parkinson's patients and for Palm Beach County's burgeoning biotech hub. State and local taxpayers spent $579 million on the Scripps Florida labs in Jupiter, plus $187 million for Max Planck Florida, also in Jupiter.
Yea. And we need the name of this _____ brokerage so we can dodge.
Russ.
I thought this might be of interest.
http://www.nytimes.com/2010/09/02/health/research/02alzheimer.html?ref=todayspaper
A new approach to treating neurological diseases.
http://www.nytimes.com/2010/07/24/health/research/24alzheimers.html?ref=todayspaper
<I know this. 'Toughening it out' is coming to peace with this dichotomy (good science/bad mgmnt), which, in my sick
and twisted mind, means giving them a piece of it. :)>
You have given them all of it many times over. You complain about the pps and your constant harping might be responsible for a small part of it. If you consider this a compliment,I suspected as much.
Yahoo,Cortex news, Business news
Just as I suspected
"Earlier financial constraints limited the timing of the study and related patient enrollment. Cortex anticipates receiving top-line results from this study in mid-2010."
17.5 million upfront would look pretty good to CORX right now or any time in the past.
Russ.
What do you make of this;
GlaxoSmithKline (GSK) entered into an exclusive licensing deal with private Austrian biotech Apeiron Biologics worth potentially $330 million. Under the terms of the deal, GSK gains exclusive rights to APN01, an early stage drug for the treatment of acute respiratory distress syndrome. Apeiron will get approximately $17.5 million upfront in cash and equity investments, and could receive as much as $330 million in developmental milestones plus royalties on any future sales. APN01 is a recombinant human angiotensin converting enzyme 2 or ACE2.
Russ.
Have you not seen 717 has been judged to have a serious flaw.
Russ.
Thank you Athero.....
Russ.
Please, A description of the hand tap test for Parkinson's disease.
Russ.
Why does Yahoo show a news flash for COR and no news on the site? I have noticed this happening quiet often recently with other of my listed stock.
Russ.
The authorized share count does not shrink with a reverse split but remains the same as I well remember from two cases I have endured.
Russ.
Iggs tells us he has so very many shares and has had them so very long that I took the liberty of searching the yahoo COR message board for his posts. There are none and he is mentioned twice. Once by Crease and once by Biotecinvestor. Draw your conclusions and please do not banter with him.
rusbrn
If insiders are willing to buy now our troubles are probably not to bad,
Click here to find out more!
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Biotech Industry Seeks Help via Change in Tax Law
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By ANDREW POLLACK
Published: December 9, 2008
Move over Big Three. Little Biotech is joining you in seeking federal assistance.
Biotechnology industry executives plan to visit Congress on Wednesday to ask for a temporary change in the tax law that would let money-losing companies get cash from the government now, in exchange for tax credits they would pledge not to take if they eventually become profitable.
The change, if Washington approved of it, could enable the industry to receive potentially hundreds of millions or even billions of dollars, on the condition that the money would be used for research and development.
The effort comes as many smaller biotechnology companies, particularly those trying to develop drugs, are facing a severe cash shortage that is forcing them to dismiss workers, curtail research and even file for bankruptcy protection or liquidation.
Prospects for the proposal are unclear.
But Allyson Y. Schwartz, a Democratic member of the House Ways and Means Committee, which handles tax matters, said she would push to include the proposal in the forthcoming economic stimulus package and expected many of her colleagues to view it favorably.
“Innovation and technology are growth areas for American businesses and American workers and should be part of this package,” said Ms. Schwartz, whose district in the Philadelphia area is home to some pharmaceutical and biotechnology offices.
A spokeswoman for President-elect Barack Obama said his transition team was not commenting on individual provisions of the stimulus package beyond what has been revealed publicly.
The big profitable biotech companies like Amgen and Genentech remain financially sound. But of the 370 publicly traded American biotechnology companies, the number with less than six months cash on hand is approximately 125 — nearly double the total last year, according to the Biotechnology Industry Organization, a trade group. Developing a drug can require hundreds of millions of dollars and 10 years or more, so even in good economic times some small companies struggle to raise money.
But with financial markets in turmoil, investors have become reluctant or unable to provide the infusions of cash, pushing many biotech companies to the brink.
In seeking assistance, the industry is quick to distinguish itself from the automakers, banks and other supplicants in Washington, portraying itself as a model of innovation and American competitiveness.
“This is not a question of our companies operating with what some perceive as a flawed business model,” said Alan F. Eisenberg, an executive vice president of the Biotechnology Industry Organization, which is known as BIO. “This is about our companies taking a decade to get a product on the market, and during that time they need to have investor capital, and that capital is not available.”
The industry’s idea is to let companies turn their very weakness — their huge losses — into an asset. Under current law, net operating losses can eventually be used to offset some taxes once a company is profitable. But that does little good for companies struggling with losses and a lack of cash now.
So the industry’s proposal would let companies receive payments from the government now in exchange for giving up those tax deductions later. The industry would agree to a cap, perhaps $30 million, on the amount any single company could receive.
Mr. Eisenberg of BIO said the proposed change would be in effect only for a year and would apply to companies outside of biotechnology as well. Few other industries, though, require as much time and money to develop a product as the biotechnology industry.
Biotechnology might not seem an obvious candidate for a bailout. The industry employs only about 200,000 people in the United States, according to the accounting firm Ernst & Young; the automobile industry employs millions.
“Research-based companies that employ 30 people don’t necessarily stimulate the economy,” said a Washington lobbyist for a large pharmaceutical company, who was skeptical the proposal would win backing.
This person, who spoke on the condition of anonymity because he was not authorized to talk to the media, said the proposal’s opponents could argue that assistance was not needed because a company with a truly promising product would be able to sell the rights to that product, or the entire company, to a larger drug company.
The biotechnology industry is also notoriously risky, with many companies never achieving profitability despite spending hundreds of millions of dollars. The chief executive of Genentech has estimated the industry as a whole has lost about $100 billion since the field’s inception in 1970s. Even as of last year, the American biotechnology industry as a whole was not profitable, although it was getting close, according to Ernst & Young.
The biotechnology industry will argue that it is responsible for creating a large number of drugs now being tested that will be needed by an aging population in the future. And it will argue that it is a bastion of American competitiveness.
“It’s one of the few places where the U.S. is the undisputed leader of the world,” said Alexis Borisy, the chief executive of CombinatoRx, a biotech company in Cambridge, Mass., that recently cut 80 employees, or two-thirds of its work force, to conserve its cash after two drugs did not perform well in clinical trials. “Do we allow that to be cannibalized?”
The industry has paved the way in developing ways to treat rheumatoid arthritis and multiple sclerosis as well as cancer drugs like Genentech’s Avastin, ImClone’s Erbitux and Celgene’s Revlimid. OSI Pharmaceuticals, which developed the lung cancer drug Tarceva, lost a cumulative $1.3 billion from its inception in 1983 through 2006 before finally breaking into the black.
Since many companies will never reach profitability, the industry acknowledges that an upfront cash payment would have to be significantly less than the value of the deductions.
For instance, Mr. Eisenberg said, a company with $100 million in net operating losses would be entitled to about $35 million in lower federal taxes when it eventually became profi
<Given the large holdings of those of us on this board, we should have board representation. Not sure if this could be done, but I would say that we collectively could give our vote over to Neuro and ask the Company to provide him with a board seat.>
At first thought that seems like a great idea,but we would loose much of his thoughts and expertise about COR since as a board member he would have to be more guarded in his comments.
Russ.
<<Less impressed with the findings is Gary J. Kennedy, MD, director of geriatric psychiatry at New York's Montefiore Medical Center. Kennedy warns that placebo-treated Alzheimer's patients in Russia get far different care than U.S. patients, who must be allowed access to existing treatments.
That would make any effect of Dimebon seem greater compared with placebo. And Kennedy says that patients' actual improvement on Dimebon is not very different from improvement seen with the existing Alzheimer's drugs Aricept, Razadyne, and Exelon.>>
<<How many of you out there feel like you've been a prisoner of COR for the last few years???>>
I have been a willing prisoner of COR for 8+ years who has on several occasions increased the sentence and I am not willing to have COR sold for $3.00. Now four or five would be a mite more palliative. I have no illusions that is going to happen any time soon,so I am willing to continue serving my time.
Russ.
I am sure someone will give you a more complete answer but I will try. If SGP were to bring to market either of their compounds in Skizo. or Depression they would owe double digit royalty to Cortex going as high as 18%. If they should bring them to market in the US for ADHD they would have to make a deal with Cortex, In Europe there is still some ambiguity about the patent status.
It seems likely they would want one of Cortex's new molecules for any new drug to market because of the extended patent life.
I know you will get a more complete rundown from others and I will read it too.
Due to a computer malfunction I have been unable to listen to the CC. Has anything been said to give an idea of status of AD pet scan trial? Date of completion or abandonment? Thanks in advance.
Russ.
The explanation is they are not accumulating yet. They are pushing the price down to scare shareholders to raise the volume and lower the price before they begin the accumulating. That is my take,and if anyone has another explanation I would like to hear it.
Russ.
How is it possible I can not access the reconfigured web site but still get the old site with the info.it will be reconfigured by the end of March?
Russ.
Why would a compound other than 717 have to be included in a RD deal? The patent life of the compound is irrelevant in this case as the indication is patented and the artifact would not be in play as usage would not be chronic.
Russ.
If they ok 717 for opioid induced RD will they have to find a "cleaner" Ampakine for sleep apnea?
Russ.
Does anyone know if the reason the trial medication for RD which the German firm put through its paces failed was it did not cure RD or that it killed the effect of pain medication?
Russ.
Davidal,
I had an account with Schwab for a year or two and was repeatedly disappointed. Have had great relations with e-trade, but they appear to be in trouble and on the block so I will probably be sold.
Russ.
OT Bambihunter,
A cure for "restless leg syndrome" is a bar of soap under the sheet near your legs. This distributed by Dr. Gott in his syndicated newspaper column. When I showed this to my son in law who suffered from this condition he laughed,but tried it. He said it works. some months later he told my daughter "It didn't work last night". When she made the bed she found the soap on the floor. I pray this helps.
Russ.
<The Japanese thought after Pearl Harbor, it wass going to be a slam dunk..>
Thank God,or fate if you must,that it was mostly battleships at Pearl and most of our carriers were elsewhere. The story would be different.
Russ.
Aiming4,
May I respectfully suggest it is time to evaluate whether it is time to show nakedmouse the black ball. It is obvious to me and some others he is a financial company shill of the bottom order.
Please consider it.
Russ.
<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. >
Apparently some have not read post #8423
Russ.
I neglected to tell you my prognostication reputation was very poor so this will merely confirm it.
Can anyone tell me why an asterisk,which normally means there is news, appears at the the COR listing on the yahoo board when the most recent news listed is June 20th.?
Russ.
I put my prognostication reputation on the line. Next week, hopefully before the 13th.
Russ.
OT Thank you very much Dr.David. Another attribute I have is I usually follow the Dr's orders. Thank you Jerry and I took your claim of short merry life with a grain of salt.
Russ.
OT Jerry,The only downer of becoming 80 or 90 is it isn't 20 or 30. Take it from one who will be 80 if he makes it another 13 days. I must confess,I have MCI and there is nothing mild about it if you have it. I call it Moderate Cognitive Impairment and I think that should be its name.
How did I make it this long? By the grace of God and mostly a moderate lifestyle with considerable exercise the last 30 or 40 years.
Russ.