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The Motley Fool April 17, 2007 Brian Lawler	Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note.
The Motley Fool July 18, 2007 Brian Lawler	More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year.
The Motley Fool April 2, 2008 Brian Lawler	Following the Drugmaker Formerly Known as Neurochem Neurochem would have been set to hear FDA news on its lead drug candidate Kiacta today, if they had not pulled their marketing application earlier this month.
The Motley Fool December 18, 2007 Brian Lawler	The Final Nail in Neurochem's Coffin The European Medicines Agency announced its refusal to approve Neurochem's lead drug, KIACTA.
The Motley Fool April 23, 2007 Brian Lawler	Neurochem Sets Low Expectations The specialty drug developer announces an update on plans to release results from a clinical study. Investors, take note.
The Motley Fool November 14, 2007 Brian Lawler	Neurochem's Crazy Choice Neurochem chooses a risky path for its lead drug candidate, attempting to have its Alzheimer's disease medication marketed as a dietary supplement.
The Motley Fool August 27, 2007 Brian Lawler	Neurochem Down for the Count? With likely two failed compounds - since the FDA rejected Neurochem's amyloidosis compound Kiacta a second time in July -- it's hard to see much value in shares of the company, considering its bare drug pipeline.
The Motley Fool June 13, 2007 Brian Lawler	Neurochem Collects the Data Neurochem hints at the data for its Alzheimer's disease drug candidate. The FDA doesn't like data that is hard to interpret, nor is it a fan of retrospective analyses. Investors, take note.
The Motley Fool June 15, 2007 Brian Lawler	Encysive's Date With Destiny Approaches A decision on the specialty drugmaker's lead drug is imminent. Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin
The Motley Fool May 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool September 24, 2007 Brian Lawler	Encysive Hears the Voice of Reason To please the FDA, Encysive Pharmaceuticals announces it is planning an additional phase 3 trial to try and bring its lead drug, Thelin, to market in the United States.
The Motley Fool January 31, 2008 Brian Lawler	When Nutraceuticals Attack After a failed phase 3 trial, Neurochem plans to market Alzhemed as a nutraceutical supplement.
The Motley Fool June 25, 2007 Brian Lawler	Neurochem Hems and Haws Neurochem delays the announcement of clinical trial results from its lead drug to treat Alzheimer's disease. Investors would be smart to stay far, far away.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
The Motley Fool June 21, 2007 Brian Lawler	Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note.
The Motley Fool November 8, 2006 Brian Lawler	Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
BusinessWeek June 12, 2006 Catherine Arnst	Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.
The Motley Fool September 6, 2007 Brian Lawler	Encysive, Please Stop Its failure to acquiesce to the FDA's request means the competition is going forward as this drugmaker's product stays stagnant. Investors, take note.
The Motley Fool May 30, 2008 Brian Orelli	No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.
The Motley Fool April 29, 2008 Brian Orelli	Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.
The Motley Fool December 31, 2011 Brian Orelli	3 More Stock-Moving Binary Events to Watch in 2012 There are a lot of drugs that will face binary events in 2012 -- here are three to watch.
The Motley Fool August 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
The Motley Fool June 18, 2007 Brian Lawler	The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note.
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool January 14, 2005 W.D. Crotty	An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling.
The Motley Fool December 3, 2007 Brian Orelli	Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.
The Motley Fool January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool February 27, 2007 Brian Lawler	FDA Keeps Novartis Waiting The pharmaceutical experiences a regulatory setback in the U.S. for one of its top drug candidates. Investors, take note.
The Motley Fool July 17, 2007 Brian Orelli	An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much.
The Motley Fool June 25, 2010 Brian Orelli	Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review.
The Motley Fool July 30, 2010 Brian Orelli	A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs.
The Motley Fool March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
The Motley Fool December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
The Motley Fool October 5, 2011 Brian Orelli	1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
The Motley Fool November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
The Motley Fool October 19, 2010 Brian Orelli	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
The Motley Fool May 1, 2007 Mike Havrilla	Heads Up, Biotech Investors Big news is in the offing for these companies. Pozen... Progenics... Zymogenetics... etc.
The Motley Fool July 10, 2008 Brian Orelli	The Death of the Approvable Letter The name's changing, but for investors, little else will.
The Motley Fool November 8, 2007 Charly Travers	BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.
The Motley Fool February 28, 2007 Brian Lawler	Discovery Prepares for Its Fate Discovery Labs announces its quarterly financial results as it prepares for another meeting with the FDA. Investors, take note.
The Motley Fool October 16, 2007 Brian Orelli	Pozen Hedges Its Bets As promised, Pozen and partner GlaxoSmithKline announce that the pair have submitted a response to their approvable letter for Trexima, and that they plan to do an additional just-in-case safety trial.
The Motley Fool November 14, 2007 Brian Lawler	Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.
The Motley Fool May 5, 2008 Brian Orelli	A Short Wait for Discovery Labs? The company gets a third letter about Surfaxin, but should be able to satisfy the FDA soon.