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The Motley Fool December 10, 2007 Brian Lawler	Neurochem's Sure Bet at Failure Investors should add another regulatory date to their biotech calendars, this one regarding Neurochem's lead drug, KIACTA.
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 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 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 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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 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 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 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 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 January 17, 2007 Brian Lawler	Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note.
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 December 29, 2006 Brian Lawler	Third Time's the Charm for Encysive? It seems like every other week we hear about a new delay for Encysive's lead drug Thelin. With shares of Encysive down more than 20% yesterday, investors can only hope that the third time is the charm for Thelin's approval from the FDA.
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 December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
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 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 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 April 3, 2007 Brian Lawler	Dendreon's Positive Panel Surprise Shares of the drugmaker jump after a FDA advisory panel finds in favor of its lead cancer compound.
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 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 August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
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 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 September 5, 2006 Brian Lawler	Neurocrine Wakes Up Indiplon The biotech company announces new drug delays. Investors, take note.
The Motley Fool September 26, 2006 Brian Lawler	Four-Bagger Biotech in One Day Acorda's shares zoomed up, but potential investors should be cautious.
The Motley Fool December 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
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 December 3, 2007 Brian Orelli	Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.
The Motley Fool January 16, 2008 Brian Orelli	Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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 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 October 8, 2007 Brian Orelli	Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt.
The Motley Fool March 3, 2009 Brian Orelli	A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals.
The Motley Fool July 25, 2006 Brian Lawler	Strike Two for Encysive The FDA still won't quite give Thelin a thumbs-up. For now, Encysive investors can only sit and wait.
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 November 10, 2009 Brian Orelli	3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme...
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 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 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 February 25, 2011 Brian Orelli	When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections?
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 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 December 11, 2006 Brian Lawler	Another Go for Encysive Drug Trials Sometimes shares of small specialty-pharma stocks rise and fall much more than warranted on every piece of news, and this appears to have happened to Encysive Pharmaceuticals.
The Motley Fool October 9, 2006 Brian Lawler	New Drug for New River An approvable letter from the FDA sends shares of New River Pharmaceuticals up.
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.