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ARNA
ARNA - FDA decision coming??
Since Arena are first up would DewD or anyone else care to handicap the outcome for me. Will it be Approval (j/k), CRL or an outright Rejection? What about a Poll? Just a thought.
Wallshrub & Biohedge
One posts and the other one has an instant reply. It's as if they know what each one is thinking. What a charade.
Dendreon Corp. (NASDAQ: DNDN) is higher on a research call as it was reiterated Buy at Needham based upon plant buildouts and over hopes of additional product revenues. Shares are up 5.5% at $35.70 on almost 100,000 shares.
Huge breakout here.
DNDN - Leerink's survey of physicians indicated no major reimbursement issues and robust demand for the launch of Dendreon's Provenge. The firm found its survey reassuring for the company's Q2 and the longer term outlook for Provenge and keeps an Outperform rating on Dendreon shares. :theflyonthewall.com
FDA Approves First Generic Enoxaparin Sodium Injection to Prevent DVT
Last update: 7/23/2010 10:48:00 AM
SILVER SPRING, Md., July 23, 2010 /PRNewswire via COMTEX/ -- The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.
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Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.
"Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product," said Keith Webber, Ph.D., deputy director of the FDA's Office of Pharmaceutical Science.
Prior to the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection. After carefully reviewing the petition, the agency determined that current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection. A response to the petition was released by the agency today.
Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh. Preventing these blood clots can prevent a pulmonary embolism, which is a sudden, potentially fatal, blockage in a lung artery that can occur if the blood clot breaks free and travels through the bloodstream to the lungs.
According to the National Heart, Lung, and Blood Institute, at least 100,000 cases of pulmonary embolism occur each year in the United States. It is the third most common cause of death among hospitalized patients.
The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and bruising (hematoma), which may cause long-term or permanent paralysis.
Approval of generic enoxaparin sodium injection has been granted to Sandoz Inc. of Broomfield, Colo. The generic product has been approved in the following strengths: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL, and 150 mg/mL. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.
For more information, including the FDA's response to the citizen petition
Enoxaparin Sodium for Injection
Generic Drugs
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Copyright (C) 2010 PR Newswire. All rights reserved
DNDN - Wallsturb??
DNDN - Who am i?
Fresh off the presses -
Quote: "DNDN has a $4b market cap - based on GENZ price/sales that would imply $1.6b in sales! DNDN has $0 sales - so they have a few years to grow into that market cap/valuation even after a 50% fall"
LMAO!! Priceless stuff.
DNDN - US Medicare agency says opens national coverage analysis for cellular immunotherapy treatment of prostate cancer such as Dendreon's Provenge, reports Reuters.
Took a few @ 25. :)
DNDN - Wallstab prediction
Here's a conversation from this person back in December when stock was trading at $25
<optionman> Wally..you got thoughts on DNDN
<optionman> looks like they got date with FDA in spring 2010
<WallStArb> approval priced in already
<WallStArb> not sure much upside even if it gets approval
<WallStArb> i dont like the risk adjusted returns
Never wrong?
By the way i was told he doesn't post his positions on his chat forum anymore ever since he was outed on that DNDN rumor nonsense he started. What's he afraid of? Probably a little thing called the truth.
I will sign off with this classic from you know who when asked about the BUY/SELL signals he gets:
<Losap> Wally what indicators do you use for buy/sell signals
<WallStArb> trusts my main one which is a SELL signal
<WallStArb> but i have a SELL signal on one indicator and a BUY signal on the other
<WallStArb> they are totally dif systems though
LOL
DNDN - Congrats to all!!!
DNDN
DNDN
DNDN
ASTM
DNDN - SAC Capital discloses 5.5% passive stake
DNDN - New All Time High today. Congrats!!