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AMRN..$8.99 Missed my opportunity to buy back in today. Rats!! It took off strong this morning. Was not watching it very close and now...there she goes!
If SCON no close above a buck _> stop out for now
Nice move on this one today.
$ULU - link back, weeeee
AFFY..$10.45 Moving strong today! AFFY has some attitude for sure.
RRU2...nice call on QCOR...congrats
ARNA..$1.92 It looked good in the pre-market at $2.16 & then reality set in. The reality is they are not VVUS and still have to get through, what will be, a tough panel in May.
PGNX..$9.79 moving nicely here on low volume of 14,000. Looking fwd to it getting back over $10/share shortly here. PDUFA date in April is closing in here.
HZNP..$3.61 Horizon Pharma announced that it has entered into a loan agreement with a group of lenders to provide $60 mln in capital (HZNP) 3.10 -0.19 : CO used $22.4 mln of the loan proceeds to repay the remaining obligations under its loan agreements with Oxford Finance LLC, Silicon Valley Bank and Kreos Capital, and expects to use the remainder of the capital to fund the ongoing commercial launch of DUEXIS in the U.S., and to pursue regulatory approval for DUEXIS in Europe and LODOTRA in the U.S.
$CXM running on this? > Phase III Efficacy and Safety Trial Completed: http://clinicaltrials.gov/ct2/results?term=Ad5FGF-4
$ULU - ULURU Inc. Announces Approval to Market Altrazeal(R) in Australia http://salesandmarketingnetwork.com/news_release.php?ID=2034549
Mylan Receives Tentative FDA Approval Through PEPFAR for Pediatric HIV/AIDS Therapy >MYL
http://salesandmarketingnetwork.com/news_release.php?ID=2034546
VVUS..$22 (Pre-Mkt): Brean Murray ups to Hold http://bit.ly/xuUL5W
A little late to the dance! Brean Murray is trying to save face here.
GRVY: Important update from IR.
Got it late last night.
Dear Mr. XXXXXXX
We are going to issue a press release in English regarding the commercial launch of RO2 in several days. While we do have a PR schedule internally, the commercial launch date may be moved one day or two earlier or later based on the results of the first some days of the open beta testing. Since the open beta testing period is expected to be relatively short and a “testing” has nothing to do with our revenues, we did not issue a separate press release for the open beta testing in the U.S.
Again, thank you very much for your valuable advice.
Kind regards,
Yoon Joo Lee
IR Manager
Gravity Co., Ltd.
QCOR..$37.40 (AH) Nice DD before earnings report. Nice pop will occur today!
Message in reply to:
$QCOR: Short covering starting before earnings report AH. As of 11am, starting to see some block buys (covering) of $1.3M, $600K, $500K, and $360K...To get interesting soon.
AUXL..$18.77 AUXL & Actelion Pharmaceuticals collaboration agreement for XIAFLEX. AUXL to receive up to $68.5M in upfront payment. http://yhoo.it/A69dFk
This is the penis straightening drug. http://www.auxilium.com/productpipeline/PeyroniesDisease.aspx
Future Link & Business News
http://www.finviz.com/futures.ashx
Target Earnings, Revenue Top Expectations
Target reported quarterly earnings and revenue that topped analysts’ expectations on Thursday, sending its shares higher in pre-market trading
http://www.cnbc.com/id/46484860
AT&T CEO pay docked $2 million for T-Mobile debacle
NEW YORK (CNNMoney) -- What's the cost of a $4 billion gamble gone wrong?
For AT&T CEO Randall Stephenson, the answer is, "$2 million." That's the sum by which AT&T's board cut his 2011 compensation as a direct response to the failed T-Mobile takeover bid Stephenson led last year.
http://money.cnn.com/2012/02/22/technology/att_ceo_pay/index.htm?iid=HP_LN
PC slump kills HP and Dell's bottom lines
NEW YORK (CNNMoney) -- Maybe HP wants to rethink that whole "we're not getting rid of the PC" decision?
http://money.cnn.com/2012/02/22/technology/hp_earnings/index.htm?iid=HP_LN
Investor 100
RGEN..$4.26 Will be looking to take a position here soon. Company has priority review for their Secreflo as well as solid data of it in use with an MRI.
Repligen announced that the FDA has accepted for filing and granted Priority Review to the co's new drug application for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis (RGEN) 4.21 : Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo NDA.
OT: Grapefruit Juice and Medicine May Not Mix http://www.drugs.com/fda-consumer/grapefruit-juice-and-medicine-may-not-mix-208.html
This is particularly true in drugs that are strong inhibitors of the CYP3A4/5 pathway. It is well known that grapefruit juice often increases plasma concentrations of drug in healthy individuals.
THLD..$6.04 Nice close today after being up over $1.00 on a down day for the market. Closed lower yesterday around $5 only to spike higher today. Interested at what conference the full data release from the pancreatic study will be released. That would be a solid catalyst knowing that information. It could be ASCO but it seems too far away.
good article with limited bs.
I do like the (IRWD) Ironwood Approval decision date: June 8, 2012.
slightly distressed at this time with there leagl isssues.
but the prelimin data looks good.
In Phase I trials reported in January 2009 in The American Journal of Gastroenterology, researchers found that 42 patients with chronic constipation who participated in the randomized, double-blind, placebo-controlled study experienced relief and that the medication was well tolerated.[2] In results of a first round of Phase III clinical trials announced in September 2010, Ironwood studied approximately 800 patients over 12 weeks who were given linaclotide or a placebo in a randomized double-blind trial. 34% of those receiving linaclotide experienced relief of pain and constipation, compared to 21% of patients who had taken the placebo. 50% of those receiving linaclotide saw a significant reduction in pain, versus 37% with the placebo, with pain reduction starting in the first week on the medication. 6% of patients left the study after experiencing diarrhea, the most common reported side effect
Under a partnership agreement announced in 2007 between Forest Laboratories and Microbia (as Ironwood was then known), Forest would pay $70 million in licensing fees towards the development of linaclotide, with profits shared between the two companies.[3] Distribution rights in the United States will be shared with Forest Laboratories, with Almirall distributing linaclotide in Europe and Astellas Pharma in Asia.
Play too keep an eye on, over the next couple of months for entry when it bottoms out.
gl
Thanks Bob for the 2012 summation....
22 Hot Drugs Facing FDA Approval in 2012
http://www.thestreet.com/print/story/11324723.html
11/29/11 - 08:55 AM EST
Updated with three additional drug approval decision dates.
BOSTON (TheStreet) -- Here's your first look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between December 2011 and July 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.
Among the highlights from the 2012 FDA drug-approval calendar that should be of most interest to bio-pharma investors: A first-quarter FDA advisory panel that will once again tackle the thorny issue of obesity-drug safety, including Vivus'(VVUS) Qnexa; approval decisions for novel inhaled medicines from Alexza Pharmaceuticals(ALXA) and MAP Pharmaceuticals(MAPP); and the fifth (!!) attempt at approval for Discovery Labs'(DSCO) lung therapy for premature infants.
Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.
Affymax(AFFY)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's(AMGN) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the U.S.
Pfizer(PFE)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012
Alexza Pharmaceuticals(ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs.
FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August.
Vivus(VVUS), Arena Pharmaceuticals(ARNA) and Orexigen Therapeutics(OREX)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.
Biogen Idec(BIIB) and Elan (ELN)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.
Columbia Labs(CBRX) and Watson Pharmaceuticals(WPI)
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012
Amylin Pharmaceuticals(AMLN)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly(LLY). Alkermes(ALKS) retains its royalty split on Bydureon sales.
Bristol-Myers Squibb(BMY)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012
Pfizer(PFE) and Protalix Biotherapeutics(PLX)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's(SNY) Cerezyme and Shire's Vpriv.
Teva(TEVA) and BioSante Pharmaceuticals(BPAX)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.
Corcept Pharmaceuticals(CORT)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.
Discovery Labs(DSCO)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.
Roche(RHHBY) and Curis(CRIS)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.
MAP Pharmaceuticals(MAPP)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.
Chelsea Therapeutics(CHTP)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012
Pfizer(PFE) and Bristol-Myers Squibb(BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012
Onyx Pharmaceuticals(ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug.
Vivus(VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.
Vertex Pharmaceuticals(VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.
Cell Therapeutics(CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.
Amgen(AMGN)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012
VVUS(VVUS)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Merck(MRK) and Ariad Pharmaceuticals(ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012
Ironwood Pharmaceuticals(IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012
Amarin(AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012
Panel Backs Weight-Loss Drug Qnexa
http://on.wsj.com/w5JYsF
VVUS..$21.00 (AH) Shares of VIVUS resume trading up 70%.
ARNA..$2.12 (AH) could be the trade tomorrow based on $VVUS vote. Been gone all day. What a solid vote count of 20-2 in favor of Qnexa.
VVUS- 19.25 up 80 percent AH FDA panel backs previously rejected obesity pill
FDA panel overwhelmingly backs previously rejected anti-obesity pill Qnexa
Associated PressBy Matthew Perrone, AP Health Writer | Associated Press – 8 minutes ago
SILVER SPRING, Md. (AP) -- A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.
The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.
The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected in April.
In a key question, the physicians said Vivus could conduct its study after FDA approval. Conducting the study ahead of market approval would cost the company millions of dollars and take at least three more years.
"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.
The FDA rejected the diet pill Qnexa in October 2010, citing numerous side effects including raised heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote Wednesday underscores the need for effective weight loss drugs.
"I think they see the medical need," Tam said. "Right now there aren't any good treatments out there besides dieting and bariatric surgery, clearly there's a huge gap."
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an antiseizure and antimigraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.
Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa. One of the two ingredients in the combination pill, topiramate, is known to more than double the risk of birth defects.
There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.
If approved, FDA scientists said they would require Vivus to train prescribers in the pregnancy risks of Qnexa and distribute warning pamphlets to patients. The drug would only be available from 10 mail-order pharmacies.
http://finance.yahoo.com/news/FDA-panel-backs-previously-apf-486349118.html?x=0
$QCOR: Short covering starting before earnings report AH. As of 11am, starting to see some block buys (covering) of $1.3M, $600K, $500K, and $360K...To get interesting soon.
SINA in a diving contest today....
hold the 65 puts for good luck....
mb
CTICjust bought @ 1.39. It has 3 catalyst dates 6/30 1 PH3 and 2 PH2 plus some very nice insider buying has begun ref this:
http://finviz.com/quote.ashx?t=ctic
jmho obviously and I am definitely nooooo guru like many of you, but it maybe worth an early look.
Chart-wise -trending up slowly- It has some gaps to fill on the down side, which when it does, assuming it is timely, it may also make it interesting. *Problem with gaps is they can fill fast, or slow, in a week, or in up to 3 years.
BOL
ALXA,
Bought a nice size position at .54 based on Tang Capital Partners,buying a 9.5% ownership recently.
They did not show up as major holders on yahoofainance,so this is all news buys.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8082966
Manny
Dendreon Corporation (NASDAQ:DNDN) seems to be on its way to recovery from the recent drop. The stock price has been falling on low volume for about 2 weeks now. I know I thought that $15 was a great buying opportunity, but I still think it is time to buy. A quick look at the daily chart of DNDN shows us that:
- The stock price has been making higher lows since January.
- The volume of transactions has been increasing substantially over the last 2 months.
- The 50 daily moving average is turning up for the first time since July 2010
- DNDN saw its short interest decrease by seven percent to 32,321,800 from 34,768,300.
- My expectation is for DNDN to rise back up to 15.21-16$ and then break out above 17.05
- This scenario would be cancelled if the price falls below 12
There is a resistance level that needs to be crossed to give rise to the next leg up. The buy trigger is at $14.66. If we can cross this level next week, the stock should continue its move up. Stay tuned !!
GRVY: Ragnarok on Apple IPhone.
Apple calls it the "The best MMORPG in the world"
http://www.playragnarok.com/violet/
$QCOR showing upswing before blowout earnings tomorrow:
A couple of reminders in case you want to be IN before the news:
QCOR’s earnings report is Wednesday, Feb. 22. TTM EPS will report a 40.5% increase, based on a 2/16/12 8K filing showing net income (before taxes) for Q ending 12/31/11 is $41M to $43M. New TTM EPS will be roughly 0.44 (= 42/33.7 x 0.35).
This will make a good play, especially after a StreetSweeper report back in January allowed shorts to drop QCOR’s PPS by 19%. However, the rather weak StreetSweeper report was effectively refuted in a rebuttal issued by QCOR.
Quarterly EPS data and estimated 12/31/11 earnings:
Period___________________12/10____3/11____6/11____9/11_____12/11
Diluted EPS________________0.10____0.17____0.21_____0.35_____0.44--(projected)
Net.Inc.B4_tax______________10.9___16.6____20.4_____33.7______42--(projected)
Net.Inc.after.Tx_____________6.42___11.2_____13.87____22.85____28.48--(projected)
ratio income B4/after tax____________________1.4704___1.4747___1.4747--(projected)
Sharecount________________65.39___65.37___65.46____66.02____66.02--(projected)
N.I./(EPS x Sh.Ct)___________0.9813__1.0099__1.0093___0.9889___0.9889--(projected)
92.9% institutional ownership (59M out of 64M sharecount):
source: http://www.nasdaq.com/symbol/qcor/institutional-holdings
54% upside (12 month analyst price target consensus $51.50)
source: http://www.nasdaq.com/symbol/qcor/analyst-research
Rated strong buy from 7 out of 7 analysts:
source: http://www.nasdaq.com/symbol/qcor/recommendations
Latest Short Interest: 10.6M (17% of float)
source: http://www.nasdaq.com/symbol/qcor/short-interest
$214M cash, and debt free
Source: 8K filed 2/16/12
15 million shares buybacks completed, 4.3M additional shares repurchase authorized
Source: 8K filed 2/16/12
Link to QCOR’s professional and effective rebuttal of a weak StreetSweeper short-selling report:
http://www.streetinsider.com/Corporate+News/Questcor+%28QCOR%29+Issues+Response+to+StreetSweeper+ReportAllegations/7084149.html
Soon after the rebuttal was issued, StreetSweeper's short position decreased substantially; they covered when they saw the preliminary news of QCOR's upcoming earningst. However, not all shorts have covered, based on NASDAQ latest daily short interest.
Starter position @ PLX ($5.55)
GLTA
Investor 100
GRVY: RO2 @ 12:22am est. on 2/22/12.
The rollout will be carried live on South Korea's biggest gamer TV channel.
http://news.mmosite.com/content/q/2012-02-21/ro2_to_start_obt_tomorrow_with_live_coverage.shtml
NOTE: A news release is forthcoming at some point. All of this upward movement happened with NO news from GRVY.
FDA acts to bolster supply of critically needed cancer drugs
FDA released this announcement today. Something to keep in mind when playing stocks that are developing cancer treatments.."+)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm?source=govdelivery
GRVY..$2.88 Held up most of the morning above $3.00 getting to a high of $3.15. Has lost some steam with the market pullback this afternoon. Will be interesting to watch the close on it today.
RGEN..$4.35 Like companies with priority review & solid data to back them. No inconclusive trials like NGSX & CHTP.
Here is another bit of news that was probably overlooked today with their FDA news. People need to remember this is the drug that has been the major area of Focus IMO. This drug will be the only one of its kind on the market.
Another piece of good news today that was probably overlooked.
Clinical pipeline updates
* Enobosarm (Ostarine(TM), GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer: GTx was granted the generic name "enobosarm" for Ostarine as a first in class agent. GTx has recently commenced two pivotal Phase III clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER) in patients with advanced non-small cell lung cancer. These clinical trials were designed based on feedback from the United States Food and Drug Administration (FDA). In the fourth quarter, GTx met with representatives of the Medicines and Healthcare Products Regulatory Agency (United Kingdom) and Medical Products Agency (Sweden), who confirmed that the design of the POWER1 and POWER2 clinical trials should be sufficient for the European Medicines Agency to support registration in Europe
RGEN..$4.30 Repligen announced that the FDA has accepted for filing and granted Priority Review to the co's new drug application for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis (RGEN) 4.21 : Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo NDA.
ECYT shortage of doxil resolved. should enable Ecyt to move forward with additional trial and EU review sooner than expected.
http://yourlife.usatoday.com/health/story/2012-02-20/New-source-found-for-cancer-drug-Doxil-in-short-supply/53181806/1
gl
UTHR..$47.33 Oral Treprostinil New Drug Application Accepted by FDA for Review. PDUFA date of Oct. 27th.
http://finance.yahoo.com/news/Oral-Treprostinil-New-Drug-prnews-829289937.html?x=0
GTXI..$3.90 FDA places clinical hold on trials evaluating Capesaris for First & Second Line Treatments of Prostate Cancer. http://bit.ly/wJQ0Vt
EGT: Entertain Gaming Asia. Breaks above 200 mov. Ave.
Thats well worth watching as the 3/08 catalyst earnings and follow CC take place.
Follow Me on Twitter: http://twitter.com/SheffStation/
New Economy Portfolio: Larger Cap stocks for slower but more consistent gains. Some Longer-Term Plays (30-60 days maybe longer)
Beginner Portfolio: Scalp Plays & Low Float Biotechs for potential explosive Growth. Quick Turnover 1-30 days (smaller balance want aggressive growth)
Position Size: STARTER: (1-5% Portfolio Balance) SOLID: (6-10% Portfolio Balance) FULL : (11-20% Portfolio Balance)
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$HEFF LEARNING STATION-LINKS
REAL-TIME Futures Quotes: http://www.sgxniftydowfutureslive.com/index_files/DOWFUTURES.htm …
JANNEY HEALTHCARE NEWSLETTER-http://www.janney.com/institutions--corporations/investment-banking/industry-groups/healthcare/life-sciences-newsletter
Traders: Develop Your Mental Edge by Dr. Andrew Menaker http://j.mp/1phyFIY
Jesse Livermore-Reminiscences Of A Stock Operator-Great Book http://bit.ly/VOObyM
LIFE SCIENCES MARKET : http://www.thelifesciencesreport.com CHMP Decisions Here: http://t.co/7jjqFyn3tx
E-booklet onTrend Determination: A quick accurate and effective methodology using RSI. http://bit.ly/17PmHZ8
The Original Turtle Trading Rules: Rules of the “Turtle Traders;” one of the greatest trading experiments conducted.
http://bit.ly/17jXegf
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One man pretends to be rich, yet has nothing. Another pretends to be poor, yet has great wealth. Proverbs 13:7
You can easily judge the character of a man by how he treats those who can do nothing for him. -James D. Miles
Favorite Sheff Quote: "You can't let praise or criticism get to you. It's a weakness to get caught up in either one." -John Wooden
Favorite Sheff Quote: Talent is God given. Be humble. Fame is man-given. Be grateful. Conceit is self-given. Be careful.
A Trading Plan = Study. A watch-list. Position Sizing. Entries. Exits. Records. Discipline. h/t @sjburns
5 Things I didn't come on twitter to do: Convince anyone of anything , Argue Defend myself Battle Trolls Waste time @sjosephburns
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