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What is GREENVAX ? !!
http://www.pharmaceutical-technology.com/projects/thegreenvaxprojectte/
The GreenVax project aims to produce vaccines from the tobacco plant on a large-scale.
Financing
In February 2010, the GreenVax project received $40m funding from the Defense Advanced Research Projects Agency (DARPA) of the US Department of Defense. The public-private-partnership is largely financed by DARPA. The G-Con and A&M will fund $21m towards the project.
The development of the tobacco-based vaccine production technology was funded through the Texas Emerging Technology Fund. In August 2010, the project also received $4m funds from the Texas Military Preparedness Commission (TMPC).
"Licensing
The new GreenVax plant will be licensed by iBio Inc. The company will provide the iBioLaunch technology platform and provide technology transfer services to G-Con to be implemented in the Bryan facility. ( IBIO : Amex )
"
Future Link & Business News
http://www.finviz.com/futures.ashx
Economic Growth Jumps to 3%; Prices Post Big Gains
The U.S. economy grew a bit faster than initially thought in the fourth quarter on slightly firmer consumer and business spending, which could help to allay fears of a sharp slowdown in growth in early 2012.
http://www.cnbc.com/id/46570434
Dow Hits 13,000, But Markets Aren't in Clear Yet
Despite the Dow and S&P 500 hitting their highest levels since 2008, investors are likely to be on edge Wednesday.
http://www.cnbc.com/id/46561414
Bankrupt Kodak asks court to let it slash retirees' health benefits
A month after it filed for Chapter 11 bankruptcy protection, Eastman Kodak Co. asked a federal court Monday to allow it to cut health care benefits for thousands of retirees.
http://bottomline.msnbc.msn.com/_news/2012/02/27/10520431-bankrupt-kodak-asks-court-to-let-it-slash-retirees-health-benefits
Investor 100
IBIO Patent Issued on Fusion-Protein Vaccine Technology
iBio, Inc. (NYSE AMEX: IBIO) today announced issuance of a US patent covering the use of iBio's proprietary fusion-protein technology in combination with influenza virus antigens for vaccine product applications. The invention comprises the use of lichenase in an adjuvant-like role to improve the performance of vaccines. This approach was developed by the Fraunhofer USA Center for Molecular Biotechnology (FhCMB), iBio's research collaborator. The new patent is US Patent 8,124,103, entitled "Influenza Antigen, Vaccine Compositions, and Related Methods".
The vaccine industry is increasingly focused on the development of subunit vaccines. These subunit vaccines require use of components called adjuvants for improving their efficacy. Lichenase, when fused to antigens acts as an adjuvant and can improve the efficacy of vaccines. Fusion of lichenase to vaccine antigens can enhance duration of immune response, improve production economies and increase product stability. This approach could provide significant advantages over more conventional methodologies used to improve vaccine efficacy.
"We consider the issuance of this patent to be an important step in the expansion of opportunities in subunit vaccine development," said Vidadi Yusibov, Ph.D., one of the patent's inventors and Executive Director of FhCMB. "We previously published data demonstrating significant improvement in candidate vaccine performance in animal models when lichenase technology is employed with a range of target antigens, including antigens from plague, malaria, and human papilloma virus."
"While iBio's principal focus has been to optimize and commercialize our proprietary platform technology for broad commercial applications across the biologics field, we also have been bringing forward lichenase as a separate proprietary product platform to be licensed to enhance vaccine performance," said Robert B. Kay, Executive Chairman and CEO of iBio. "Based upon the results obtained in multiple animal studies and the formulation advantages of using a fusion protein, we believe there will be substantial commercial interest in lichenase as a proprietary approach for potent subunit vaccines."
This patent is an important addition to iBio's broader intellectual property portfolio that includes the clinical-stage iBioLaunch™ platform for vaccines and therapeutic products.
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch™ platform, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. The iBioLaunch platform is a proprietary, transformative technology for development and production of vaccines and therapeutic proteins using transient gene expression in green plants. The technology has been applied successfully to proteins difficult or impossible to produce with other methods, as well as proteins representative most important classes of biologic pharmaceuticals. Advantages of the iBioLaunch platform over other systems include enablement of rapid development and validation of modular, scalable, and optionally robotic, multi-product manufacturing facilities; production time measured in weeks instead of months or more; product entry that is unconstrained by traditional process patents; and significantly lower capital and operating costs for comparable production. Further information is available at: www.ibioinc.com.
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist with the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
GRVY: 2/29 Update from IR.
Dear XXXXXXXXXX
Thank you for your inquiry.
Since RO2 still has some technical errors (bugs) like many other games in the OBT stage, we may need some more time to fix them. Currently, we expect the launch date will be in March.
Again, I do know that our investors are waiting for news but we would like to disclose information when it is finalized. Your understanding is much appreciated.
Thank you.
Kind regards,
Yoon Joo Lee
IR Manager
Note: Above email redacted for privacy:
ARNA-VVUS-OREX,
Weight-loss companies in play--Bloomberg
"Vivus could now lure interest from Johnson & Johnson (JNJ), Merck & Co. and Bristol-Myers Squibb Co. (BMY), with annual sales of the Qnexa pill projected to reach $5 billion by 2020, according to Rodman & Renshaw LLC. After more than a decade of weight-loss treatments presented risks from heart disease to brain tumors, the FDA’s receptivity to Qnexa may also put rival obesity-drug developers Orexigen Therapeutics Inc. (OREX) and Arena Pharmaceuticals Inc. (ARNA) in play as more than one-third of U.S. adults suffer from obesity, JMP Securities said.
“The FDA has clearly crossed the Rubicon of balancing risk and benefit, understanding that the obesity problem is a pandemic,” Michael King, a New York-based analyst at Rodman & Renshaw, said in a telephone interview. “There are not a lot of products around in the pharmaceutical industry that address such large market opportunities. Vivus is not going to give this up cheap.”
http://www.bloomberg.com/news/2012-02-29/obesity-epidemic-prompting-vivus-takeover-talk-with-68-windfall-real-m-a.html?cmpid=yhoo
OT: Will be back posting on the thread more on Wednesday evening. Been in meetings all day Tuesday & will be on Wednesday as well. Limited trading & posting during trading hours.
CXM: Cardium Investor Relations email.
I bought a bit more today because I am confident Cardium is going to make significant news in March on at least one front and maybe others as well.
Excerpt from IR:
"As we have reported, we are planning for the market introduction of Excellagen, which is expected in first quarter ending March 31, 2012 and the initiation of the Generx ASPIRE late stage/registration study which is expected in the first quarter ending March 31, 2012. In addition, we plan to further expand our MedPodium Nutra-Apps product portfolio with additional product offerings and broadening distribution of the brand platform nationally and into the food, drug and mass markets"
NOTE: Imo, CXM looking very good here. Funding in place. A nice spot to ease in to position.
ALXA,
Up 8.16% to .5949.(high of .62)
According to this Finviz chart,at over .60,ALXA breaks a downward channel,and should bring in new traders and investors.
http://finviz.com/quote.ashx?t=alxa&ty=c&ta=1&p=d
Manny
AVII:AVI BioPharma Announces FDA Approval to Proceed With a Modified Dosing of AVI-6003 for Treatment of Marburg Virus
AVI-7288, a Component of AVI-6003, Shows Efficacy Results in Standalone Treatment of Non-Human Primate Studies
BOTHELL, WA--(Marketwire -02/28/12)- AVI BioPharma, Inc. (NASDAQ: AVII - News), a developer of RNA-based therapeutics, today announced that it has received approval from the Food and Drug Administration (FDA) to proceed with a single oligomer, AVI-7288, in studies in both humans and non-human primates to support the safety and efficacy of post-exposure prophylaxis against Marburg virus infection. AVI-7288 is one of two components that make up AVI-6003. Studies conducted to date have shown that efficacy in non-human primates can be attributed to this single component, while the second component, AVI-7287, does not appear to contribute to efficacy. AVI is conducting this work under a Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office, a component of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). The FDA approved proceeding with the Marburg program using the single oligomer AVI-7288 under the original IND.
http://finance.yahoo.com/news/AVI-BioPharma-Announces-FDA-iw-4179795439.html?x=0
Investor 100
ALIM- Alimera Sciences Announces Positive Outcome to the European Decentralized Procedure for Approval of ILUVIEN(R) for the
ILUVIEN® expected to be the first sustained release pharmaceutical in the European Union to treat diabetic macular edema (DME)
ILUVIEN expected to be indicated for chronic DME considered insufficiently responsive to available therapies
Alimera Sciences, Inc., (Nasdaq:ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the positive outcome of the Decentralized Procedure (DCP) for ILUVIEN® in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that ILUVIEN is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that, in these seven countries alone, 22.1 million people are currently living with diabetes. By comparison, the Centers for Disease Control and Prevention estimate that Americans with diabetes now number 25.8 million. Alimera estimates that within the seven CMS countries, 1.2 million people suffer from DME.
"Achieving a favorable conclusion for ILUVIEN in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," said Dan Myers, president and chief executive officer, Alimera Sciences. "We will continue to work closely with the UK and the Concerned Member States to ensure that ILUVIEN is made available to patients as soon as possible."
ILUVIEN is Alimera's sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.
"Our market research indicates that, given DME is a leading cause of blindness in working-age adults, there is a significant opportunity for an effective ophthalmic drug to treat patients insufficiently responsive to available therapies," said Dave Holland, senior vice president of sales and marketing, Alimera Sciences. "An effective, truly long-term treatment option could have a very positive impact on the quality of life for patients with this chronic debilitating disease."
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat chronic DME. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.
In July 2010, the Marketing Authorization Application (MAA) was submitted to seven European countries via the DCP with the UK MHRA as the RMS. The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME™ Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. Based on a consensus arrived upon by the RMS and the CMS, the MHRA issued its Final Assessment Report that ILUVIEN is approvable.
TZA swingposition, added premarket , cost avg 18.20
ALTH,
Sales were for a reason.Here is an example.
1. These shares are being sold pursuant to a 10b5-1 plan for Paul L. Berns in order to cover the withholding tax and other costs associated with such sale (i.e., wire fees, commission or interest) in connection with the vesting of restricted stock units on February 22, 2012.
2. These shares are being sold pursuant to a 10b5-1 plan for Paul L. Berns in order to cover the withholding tax and other costs associated with such sale (i.e., wire fees, commission or interest) in connection with the vesting of restricted stock units on February 23, 2012.
manny
$ALTH insider dumpathon:
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096820
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096828
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096834
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096842
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096838
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8096847
ECYT
citigroup conference call:
http://investor.endocyte.com/events.cfm
http://www.veracast.com/citigroup/healthcare2012/events/1131_endocy/pdf/Endocyte.pdf
gl
ALXA,
In a 13G filing,Boxer capital owns 6.7% of ALXA.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8095658
They must have bought these shares in ALXA's latest offering at .50.
I don't see them as a major holder on yahoofinance.com before the offering.
http://finance.yahoo.com/q/mh?s=ALXA+Major+Holders
Manny
GTXI $3.69 Coming back from the unjustified pounding they took last week.
Sheff,
This piece is a great find in your DD on Talon. I am an optimist on Talon's chances of approval and really think this company has huge potential written all over it. My understanding from past CC calls is that they would like to market and sell Marqibo for the smaller ALL indication themselves rather than partner with big pharma.
On the other hand, their other drug in development, Menadione, will have their Phase 2 clinical trial results by the end of the year, which is being conducted by the Mayo Clinic. If the results are very positive, I think Menadione will be partnered with big Pharma as it is a therapeutic cream for the treatment/prevention of skin rash in cancer patients using treatment of all approved EGFR inhibitors such as Erbitux, Tarceva,Tykerb,and Vectibix.
AFFY..$10.66 Moving strong today. Key conference on Wed 29th at 2012 CITI Global Health Care Conf at 10:30 est.
TLON..$.93 2008 review from Richard Pazdur on Endpoints for Assessing Drug Activity in Clinical Trials in the Oncologist. http://bit.ly/xcoDlQ. Key endpoints are discussed that are important to current & future trials.
"In rare diseases where randomized trials cannot be
performed because of very limited populations, the FDA
has approved indications on the basis of single-arm studies
supported by data from the published literature."
Endpoints for assessing drug activity in clinical trials.
http://www.ncbi.nlm.nih.gov/pubmed/18434634
Pazdur R.
SourceCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20825, USA. pazdurr@cder.fda.gov
Abstract
Overall survival remains the gold standard for the demonstration of clinical benefit. An improvement in overall survival is a direct clinical benefit to patients. An analysis of overall survival requires larger patient numbers and longer follow-up than other endpoints. Survival analysis may be confounded by subsequent therapies. Time to progression usually requires smaller clinical trials and may be more rapidly assessed than trials using overall survival as an endpoint. This endpoint is not confounded by subsequent therapies. Time to progression must use the same evaluation techniques and schedules for all therapies being evaluated. Blinding of trials or the use of an external blinded radiographic review committee is recommended in assessing time to progression. Unlike overall survival and time to progression, which must be evaluated in randomized trials, response rates can be accurately assessed using a single-arm trial. Stable disease is not included in a response rate determination and is optimally evaluated by assessing tumor progression in a randomized trial. Improvement in disease-related symptoms is considered clinical benefit and may be an appropriate endpoint for drug approval.
BPAX:BioSante’s Pancreas Cancer Vaccine Shows over 60% Survival Increase in Newly Presented Study
One year survival increased from 7% to 27%
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX - News) today announced presentation of results from a Phase Ib clinical study that show its GVAX Pancreas cancer vaccine increased the median survival of pancreatic cancer patients with previously treated, locally advanced or metastatic pancreatic adenocarcinoma (PDA), from 3.3 months when treated with ipilimumab (IPI; Yervoy; BMS), to 5.5 months on the combination of IPI plus GVAX Pancreas, an increase of more than 60 percent. The study was not powered for a direct comparison. In addition, the IPI/GVAX Pancreas combination demonstrated an increase in one year survival, from 7 percent to 27 percent. A new multicenter clinical study is planned to begin this year.
http://finance.yahoo.com/news/BioSante-Pancreas-Cancer-bw-1312072336.html?x=0
Investor 100
DNDN..$14.15 pre-market. I actually traded this poorly and lost on it this a.m. I woke up late and got out of this at $14.50 pre-mkt after getting in last week at $15!! Completely forgot about this stock this morning. I cannot believe I overslept & did not trade this right!! Not happy with myself at all. Nice trade Cabos!!
$CASM CASMED's FORE-SIGHT(R) Absolute Tissue Oximeter Gains FDA Clearance for Use on Neonatal Abdomen
http://salesandmarketingnetwork.com/news_release.php?ID=2034561
Sheff, Thank you for the heads up on DNDN Friday! Out at 15.89 from a 15.02 entry Another base hit!
http://finance.yahoo.com/news/Dendreon-Reports-Fourth-bw-2715899205.html?x=0
$DCTH - Delcath Announces First CHEMOSAT Procedures in Germany
http://salesandmarketingnetwork.com/news_release.php?ID=2034558
GALE:Galena Biopharma Establishes Record Date for Spin-Off Stock Dividend of RXi Pharmaceuticals Shares
LAKE OSWEGO, Ore., Feb. 27, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE - News), a biotechnology company focused on developing innovative, targeted oncology treatments, today announced, as required by NASDAQ Listing Rule 5250(e)(6), that its Board of Directors has declared a conditional spin-off stock dividend on Galena common stock of one share of common stock of RXi Pharmaceuticals Corporation, a subsidiary of Galena, for each outstanding share of Galena common stock. The dividend of RXi shares will be made pursuant to the registration statement filed by RXi with the Securities and Exchange Commission and declared effective on February 14, 2012.
http://finance.yahoo.com/news/Galena-Biopharma-Establishes-pz-4113368673.html?x=0
Investor 100
Full Story via AMTD Streamer
Affymax to Receive $5 Million Milestone Payment for Acceptance of European Marketing Authorization Application for PeginesatideLast update: 2/27/2012 8:00:06 AMPALO ALTO, Calif., Feb 27, 2012 (BUSINESS WIRE) -- Affymax, Inc. (AFFY) today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide. The milestone is triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for the investigational compound peginesatide for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. "We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA," said John Orwin, president and CEO of Affymax. "While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the U.S." Peginesatide was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States. Takeda has commercialization rights in the European Union. In the United States, the scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.
Affymax To Receive $5 M Milestone Payment For Acceptance Of European Marketing Authorization Application For PeginesatideLast update: 2/27/2012 8:00:28 AM(MORE TO FOLLOW) Dow Jones Newswires (212-416-2400)February 27, 2012 08:00 ET (13:00 GMT)
RGEN:Repligen Launches New Products in OPUS™ Line of Pre-Packed Chromatography Columns
- Larger Columns Expand Utility of Unique Open Platform for Biologics Purification -
Repligen Corporation (NASDAQ:RGEN - News) today announced the launch of its new larger-scale OPUS™ brand chromatography columns used in the manufacture of biopharmaceuticals. The OPUS™ (Open Platform User Specified) line extension is being introduced in response to rising market demand for disposable technologies in biopharmaceutical manufacturing. Such technologies are revolutionizing biomanufacturing by enabling increased facility flexibility and operating efficiencies. The new OPUS™ chromatography columns are now commercially available to biopharmaceutical manufacturers and developers worldwide.
http://finance.yahoo.com/news/Repligen-Launches-New-bw-4025254504.html?x=0
Investor 100
Future Link & Business News
http://www.finviz.com/futures.ashx
EUROPE, OIL IN FOCUS
NEW YORK (CNNMoney) -- U.S. stocks were set to open lower Monday as concerns on Europe's debt crisis returned and gas prices continued to rise.
http://money.cnn.com/2012/02/27/markets/premarkets/index.htm?iid=Lead
Lowe's Quarterly Profit Rises
Lowe's posted a higher quarterly profit as comparable store sales rose 3.4 percent at the No. 2 U.S. home improvement chain.
http://www.cnbc.com/id/46512717
Buffett on housing: Was "dead wrong," but still believes
Warren Buffett says "hormones" will save the housing market. But this time he's not saying exactly when.
http://finance.fortune.cnn.com/2012/02/25/buffett-on-housing/?iid=HP_LN
Investor 100
CRIS:Curis to Present at the 32nd Annual Cowen and Company Health Care Conference
LEXINGTON, Mass., Feb. 27, 2012 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS - News), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, today announced that the Company will be presenting at the 32nd Annual Cowen and Company Health Care Conference at 1:30 p.m. EST on March 5, 2012, in Boston, MA.
http://finance.yahoo.com/news/Curis-Present-32nd-Annual-pz-3828680000.html?x=0
Investor 100
CBRX:Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
PPS:.79
PARSIPPANY and LIVINGSTON, N.J., Feb. 27, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI - News) and Columbia Laboratories, Inc. (Nasdaq: CBRX - News) today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.
http://finance.yahoo.com/news/Watson-Receives-Complete-prnews-583477954.html?x=0
Investor 100
Here you go baggers.
http://www.biopharmcatalyst.com/
Investor 100
TLON..$.93 Accelerated Approval Dust begins to settle. Good article from Nov 2011.
http://www.nature.com/nrd/journal/v10/n11/pdf/nrd3580.pdf
"The higher the unmet need, and the fewer the patient options, the more willing the FDA is going to be to consider an accelerated filing."
The FDA has done this already for TALON. Remember that Ariad & ONXX were never given the accelerated approval "pathway" (subpart H) for their drugs.
AFFY..$10.38 Affymax Announces Upcoming Webcasts and Conference Participation
February 21, 2012 4:00 p.m.
PALO ALTO, Calif., Feb 21, 2012 (BUSINESS WIRE) --
Affymax, Inc. (Nasdaq:AFFY) today announced the company's participation at the following investor conferences over the next several weeks.
Citi 2012 Global Health Care Conference Wednesday, February 29, 2012 10:30 a.m. Eastern Time
Cowen & Company 32nd Annual Health Care Conference Tuesday, March 6, 2012 10:40 a.m. Eastern Time
ONXX..$38.52 Onyx Beats; Says 2012 Vital http://dlvr.it/1FJ8cn
IPXL..$23.49 FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson's Disease. The Prescription Drug User Fee Date (PDUFA) for a decision by the FDA is October 21, 2012. http://dlvr.it/1FJy7T
New FDA-Approved Oncology Drugs and Indications in 2011
http://bit.ly/v4rSEW
OT: Tax changes to watch for in 2012. http://yhoo.it/zYEzr6
EXEL..$5.77 A new peer-reviewed article demonstrates reduction of tumor invasiveness & metastasis in preclin pancreatic cancer. Interesting data here in a hard to treat tumor.
http://bit.ly/ylEewN
TLON..$.93 Key information from their 2010 ASCO presentation from their RALLY study. The data is far from "underwhelming" and is very impressive. This is in 3rd-6th line patients who had already been on regular vincristine. The results are significant in a disease with few options. This is why the FDA granted "accelerated approval." Accelerated meaning conditional approval with Phase II instead of Phase III data and not standard review to priority review. Priority review meant nothing to Talon if they could not get the confirmatory studies up and running in time. The extra 4 months (standard review) has given them time to get their studies in place. Still waiting on a pt to be enrolled in the HALLMARQ conf Phase III study. Standard review was best for Talon.
The FDA also gave them a SPA for their confirmatory Phase III study understanding that if they approved them on single trial Phase II data that the company would have sufficient time to demonstrate that their durable response would translate into a meaningful clinical benefit (i.e. increased survival advantage). This was the 56 pt study as the data has been updated to include the 65 pt study as well. Still solid data.
TLON..$.93 The company's recent financing of the 11m can only be satisfied if the company increased the A/S. There are shares that need to be converted at .30 from that deal eventually. The company had to increase the A/S. The deal is with Deerfield. That is the least of an investor's worry right now. What is on my mind is making sure the company has dotted the I's and crossed the T's with the upcoming AdCom Panel.
Follow Me on Twitter: http://twitter.com/SheffStation/
New Economy Portfolio: Larger Cap stocks for slower but more consistent gains. Some Longer-Term Plays (30-60 days maybe longer)
Beginner Portfolio: Scalp Plays & Low Float Biotechs for potential explosive Growth. Quick Turnover 1-30 days (smaller balance want aggressive growth)
Position Size: STARTER: (1-5% Portfolio Balance) SOLID: (6-10% Portfolio Balance) FULL : (11-20% Portfolio Balance)
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$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
FAVORITE QUOTES:
"Compounding interest is the eighth wonder of the world. He who understands it, earns it..he who doesn't.. pays it." - Albert Einstein
"Your actions speak so loud I can't hear your words! When that happens, you have found a certain level of success others haven't." Sheff
"IF YOU ARE NOT TAKING YOUR PROFITS, SOMEBODY ELSE IS !" SHEFF
A good name is more desirable than great wealth. Respect is better than silver or gold. -Proverbs 22:1
Don't brag about yourself let others praise you. -Proverbs 27:2
Do not brag about tomorrow, because you do not know what another day may bring. -Proverbs 27:1
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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