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Cambridge Heart Induces Tachycardia
Investors awaiting the CMS' national coverage decision today were biting their fingernails as the stock dropped more than 15% without any news depsite all sources saying March 21st would deliver the verdict. As we write this article, only Bloomberg and the Cambridge Heart website confirm the positive decision that CMS has indeed approved national coverage for Microvolt T-wave Alternans when the spectral analytic method is used (a method unique to CAMH's machine). Well, let us be the first to congratulate those who know a good product and good data when they see it. The NCD was positive and the stock should reflect as much when the bell rings tomorrow. Read moreThe Money Shot: Heart Healthy Recommendations
This year’s conference promises to have some important Late Breaking results. Here’s what to watch for: Read moreThe Money Shot: 3 for the Road Sanofi (SNY) - $$ - Selling at around $46, it‘s no bargain but the world’s third largest pharmaceutical company has quite a few in the pipeline and just made a $3.1 billion sale to Pfizer for their share of the inhaled insulin hopeful, Exubera. Many of us, aka me, are still confident that Acomplia (rimonabant), the endocannabinoid blocker will be successful – how can you go wrong with a drug that reverses the munchies?
Now they are filing a new drug application (NDA) for an old friend: Plavix. And you know what we (me again) say about Plavix (clopidogrel): it never loses. The new indication, which is to receive expedited review by the FDA is for ST-elevation MIs. What you have to know about this is that it’s basically the only indication they don’t have in treatment of coronary artery disease. Recent large scale studies have indeed demonstrated benefit in this setting so there’s no reason to think it would be rejected. http://www.sanofi-aventis.us/ Genta (GNTA) - $ - A good prospect at $1.80? We think so and we were right about Cambridge Heart (CAMH). The Genasense® (oblimersen sodium) Injection is the Company's hot product from its oligonucleotide program... Read moreMoney Shot: We’re Not Gonna Say It, But…
Granted, it didn’t have far to go to triple in value ($0.29 to $0.87), but you still end up with 3x more money then when you started. Why the sudden increase in value and trading volume?
Well, the Journal of American College of Cardiology (JACC) published an NIH-sponsored study ("Microvolt T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients with Left Ventricular Dysfunction.") online showing that the microvolt t-wave alternans (mTWA) study is a far better predictor of who benefits from AICD implantation than ejection fraction, the current predictor by way of the SCD-HeFT and MADIT-2 trials. Following this publication, the stock inched up about $0.05. The big bump occurred about one week later when the Center for Medicare and Medicaid Services (CMS) proposed a national coverage decision for mTWA for patients at risk for sudden cardiac death. Read moreThe Money Shot - Imclone Short Changed? There are just some companies out there that despite repeated failures, maintain a strong market presence. Imclone Systems Inc (IMCL) is one of those. Despite the rocky road it has traveled over the past 2 years, it’s one and only product, Erbitux, has kept it from plummeting off the Nasdaq exchange altogether. After peaking at more than $80 in July 2004, the company’s CEO, Sam Waksal, faced very public and embarrassing insider trading allegations for which he is now in prison. Also involved were his brother, Harlan, and uber-homemaker/CEO Martha Stewart who also served prison time for her premature dumping of the stock before word of its 2001 FDA rejection became public. Read more Sugar, Mama: The Inhaled Insulin Race- The Money Shot IV Inhaled insulin is finally moving out of the realm of implausibility and Wall Street is racing to predict who will reap the sweet rewards.Considering all the hoopla generated over the recent positive data on Imclone's (IMCL) only drug, Erbitux, you would figure that the imminent inhaled insulin battle would plunge the biotech industry into turmoil. Erbitux, which originally was intended to treat late-stage colon CA, also showed positive results in head and neck CA trials. This can expand its patient population to what, 20,000 more people annually? Read more Money Shot Part II: Getting Started It’s been nearly a month since I wrote the first edition of The Money Shot Part I: Getting Excited. In the last episode we talked about the advantages that you, as young well-read docs, have over the biotech analyst and regular ol’ stock trader. That is, you have an intimate knowledge of the formulary and what attendings are prescribing as well as the background knowledge to help you understand the myriad news published daily about drug trials.I concluded last month’s piece by promising to give you a good way to introduce yourself to the world of biotech/pharm stocks- so here it is: Read more The Money Shot: Ximelagatran Bares AllXimelagatran, aka Coumadin-lite, has been struggling to earn FDA approval. The drug, not currently approved for the U.S. market because of questions about liver damage, appears to be as effective as other common therapies for preventing strokes and recurring blood clots, according to studies published on Tuesday.AstraZeneca's wonder-pill, is so intriguing because it is oral anticoagulation that does not require INR levels to be checked and is a helluva lot easier to give at home than Lovenox. It has already been approved for short-term use in parts of Europe. Why is this a subject for The Money Shot crew? Well, Astra-Zeneca (AZN) was selling at $50 one year ago and now sits tenuously at $39. Arguably, much of this drop is secondary to its failure to gain approval for Exanta in the US. Read more |
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