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ECYT...$3.69 Pulled back a little but they still have 2 investment conf upcoming in late Feb. Citbank on 27th and RBC capital 28th.
GRVY..$2.57 This is the trailer for Ragnarok II. There are 40m users for this from the first one. http://bit.ly/z2hRhb
CLSN..$2.16 Brean Murray starts at Buy and $7 target. http://bit.ly/yfgB6R
CLSN:Celsion Announces First Patient Enrolled in Phase II Study of ThermoDox(R) in Combination With RFA in Colorectal Liver Metastases
This Study Will Capitalize on the Compelling Results From the Company's Phase I Dose Escalation Trial
LAWRENCEVILLE, NJ--(Marketwire -02/13/12)- Celsion Corporation (NASDAQ: CLSN - News), a leading oncology drug development company, announced today that the first patient has been enrolled in a randomized Phase II study of the Company's lead product candidate, ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM).
http://finance.yahoo.com/news/Celsion-Announces-First-iw-508522664.html?x=0
Investor 100
BPAX:BioSante Exchanges $4 Million Aggregate Principal Amount of Convertible Senior Notes for 4.5 Million Shares of Common Stock
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX - News), announced today that the company has entered into a privately-negotiated securities exchange agreement with a holder of BioSante’s 3.125% convertible senior notes due May 1, 2013. Pursuant to the terms of the agreement, BioSante issued 4,485,159 shares of its common stock to the note holder in exchange for an aggregate of $4.0 million principal amount of notes, including accrued and unpaid interest. Following such exchange, an aggregate of $11.8 million principal amount of the notes will remain outstanding.
http://finance.yahoo.com/news/BioSante-Exchanges-4-Million-bw-2174550062.html?x=0
Investor 100
APRI:Apricus Bioscience's Wholly-Owned Subsidiary NexMed (USA) Signs Exclusive German Collaboration for Vitaros(R) for Erectile Dysfunction
SAN DIEGO, Feb. 15, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI - News) (http://www.apricusbio.com) announced today that its wholly-owned subsidiary NexMed(USA), Inc. has signed with Sandoz, a division of Novartis, an exclusive collaboration for Germany to market Apricus Bio's Vitaros(R) drug for the treatment of erectile dysfunction.
http://finance.yahoo.com/news/Apricus-Bioscience-Wholly-pz-3560394225.html?x=0
Investor 100
CRIS:Curis and Debiopharm Announce Initiation of Phase Ib Expansion Study of HSP90 Inhibitor Debio 0932
LEXINGTON, Mass., and LAUSANNE, Switzerland, Feb. 16, 2012 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS - News), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, and Debiopharm Group (Debiopharm), a group of companies with a focus on the development of prescription drugs that target unmet medical needs, today announced that Debiopharm has begun treating patients in a Phase Ib clinical trial of Heat Shock Protein 90 (HSP90) inhibitor Debio 0932. Debiopharm recently successfully completed a Phase Ia dose escalation study with Debio 0932 and has indicated that it expects to initiate a combination Phase I/II study in non-small cell lung cancer patients in the second quarter of 2012.
http://finance.yahoo.com/news/Curis-Debiopharm-Announce-pz-881485314.html?x=0
Investor 100
AMRN- Amarin Corporation Appoints Dr. Steven Ketchum to Head Research and Development and Announces Inducement Grant Under NASDAQ Rule 5635(c)(4)
BEDMINSTER, N.J., and DUBLIN, Ireland, Feb. 16, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN - News), a late-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that Steven Ketchum, Ph.D., has been appointed President of Research and Development, Senior Vice President, effective February 16, 2012. Dr. Ketchum will be responsible for Amarin's drug discovery, preclinical and clinical development program and regulatory and medical affairs activities, including the ongoing development and regulatory review support for Amarin's lead product candidate, AMR101.
Dr. Ketchum joins Amarin with a significant record of achievement in the life sciences industry, with 20 years of experience in late-stage product development and clinical regulatory strategy, having led the filings of multiple successful new drug applications (NDAs) and supplemental NDAs. Most recently, Dr. Ketchum served as Senior Vice President, Research and Development for Sunesis Pharmaceuticals where, as a member of the Executive Committee, he provided strategic direction for all facets of research and development, including clinical strategy and operations, regulatory affairs, and pharmaceutical development. Prior to Sunesis, Dr. Ketchum was Senior Vice President, Research and Development and Medical Affairs at Reliant Pharmaceuticals with responsibilities for leading the strategic direction and day-to-day operations of Reliant's clinical research, product development, and medical affairs departments. Dr. Ketchum has also served as Senior Vice President, Operations and Regulatory Affairs for IntraBiotics Pharmaceuticals, Inc., where he was responsible for regulatory affairs, project management, quality assurance, and supply chain management in support of late-stage clinical research. Dr. Ketchum also held positions with increasing responsibility in regulatory affairs during his nearly eight-year tenure at ALZA Corporation.
Dr. Ketchum earned a Ph.D. in pharmacology from University College London and a B.S. in biological sciences from Stanford University.
"We are delighted to announce this important appointment and to welcome Steve to Amarin's executive management team," stated Joseph Zakrzewski, Chairman and CEO. "I have known Steve since working with him at Reliant Pharmaceuticals and had the privilege of working with him extensively on Lovaza/Omacor. Steve's expertise and depth of knowledge in Omega 3 product development and strong business acumen will serve Amarin well. Steve's addition reflects Amarin's optimism for its future as his appointment results in the strengthening of an already strong R&D team."
"This is an exciting time to be joining Amarin. I believe AMR101 has the potential to become the next-generation treatment for patients with elevated triglyceride levels," said Dr. Ketchum. "It's great to be a part of this dynamic company, and I look forward to working with the Amarin team to advance AMR101 through regulatory review to commercialization."
In connection with this appointment, Amarin granted Dr. Ketchum an inducement equity award in accordance with NASDAQ Listing Rule 5635(c)(4). The grant, which was made outside the Amarin 2011 Stock Incentive Plan, was approved by the Remuneration Committee of the company's Board of Directors, and the Board of Directors, as an inducement material to Dr. Ketchum's entering into employment with Amarin. The grant to Dr. Ketchum consists of nonqualified options to purchase 600,000 shares of the Amarin ordinary shares represented by American Depositary Shares ("Shares") with a 10-year term and an exercise price equal to the closing price of Amarin American Depositary Receipts on the date of grant. Twenty-five percent of the options will vest on the first anniversary of Dr. Ketchum's start date with Amarin with the remaining seventy-five percent to vest ratably over the subsequent 36-month period, subject to Dr. Ketchum's continued employment with Amarin over such period. If, within 24 months of a change of control of Amarin, Dr. Ketchum is terminated without cause or voluntarily terminates his employment for good reason, he will receive immediate vesting of all outstanding stock options. Dr. Ketchum would receive 6 months of accelerated vesting if terminated without cause not following a change of control of Amarin or outside of the 24-month period following a change of control.
http://finance.yahoo.com/news/Amarin-Corporation-Appoints-pz-1255045382.html?x=0
GNOM- Complete Genomics Launches Genomic Discovery Software Partners Program- Partner Offerings Complement Complete Genomics' Data to Help Customers Expedite Biological Discoveries
GlobeNewswirePress Release: Complete Genomics –
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Symbol Price Change
GNOM 4.05 0.00
MOUNTAIN VIEW, Calif., Feb. 16, 2012 (GLOBE NEWSWIRE) -- Complete Genomics Inc. (Nasdaq:GNOM - News), the whole human genome sequencing company, today introduced its Genomic Discovery Software Partners Program. Ingenuity(R) Systems, Golden Helix and DNAnexus have been chosen as initial partners because they have offerings that complement the information supplied with Complete Genomics' sequencing service and can expedite the genetic research of its customers.
"Researchers have been using advanced analysis, storage and visualization capabilities from our partners to complement our mapping, genome assembly, variant calling and annotation capabilities," said Dr. Clifford Reid, chairman, president and CEO of Complete Genomics. "We are launching this program to let the entire genetic research community know that these partners offer solutions compatible with Complete Genomics' data that can accelerate the pace of biological discoveries."
Ingenuity Variant Analysis(TM) is a new software product focused on enabling rapid filtering and annotation of variants from human re-sequencing studies. It helps researchers prioritize among millions of variants and identify those that are most likely to be biologically significant. This tool leverages Ingenuity's Knowledge Base, a database of more than 4 million findings gleaned from peer-reviewed journals and literature and other public genomic data sources, to more easily make connections between genomic variants and biological pathways. It can identify causal variants for a rare disease, driver variants for a particular cancer, or variants associated with response or non-response to a therapeutic or rare adverse event.
"Accurate biological interpretation is critical to efficiently identify causal variants from DNA re-sequencing studies," stated Professor Peter van der Spek, Ph.D., Erasmus University Medical Center. "The partnership between Complete Genomics and Ingenuity Systems creates an easy, powerful way for researchers to quickly prioritize and identify biologically relevant and actionable variants that are most relevant to disease progression or drug response."
Dr. van der Spek's recent work with Complete Genomics and Ingenuity Systems resulted in the identification of a novel causal variant for craniosynostosis,1 a congenital malformation of the skull.
Golden Helix's SNP and Variation Suite (SVS) is a desktop solution that combines powerful variant classification, bioinformatic filtering, functional annotation, visualization and statistical analysis capabilities into one flexible product. By allowing customers to take control of individual steps within the analysis process, SVS empowers them to quickly uncover statistically significant genotype-phenotype associations or causal variants in large-scale data.
DNAnexus, which previously partnered with Complete Genomics, is joining the program to provide an instant genomics data and analysis center with its cloud-based solutions for customers' human genome sequencing data. DNAnexus offers feature-rich data visualization and interpretation tools to view and filter variant, CNV, SV and read data through a user-friendly Web service that requires no additional software or hardware investment. The secure and scalable platform provides a collaborative environment between researchers across different institutions.
Complete Genomics will continue to expand its group of Genomic Discovery Software Partners as other companies demonstrate significant value to its customers.
Attendees at the Advances in Genome Biology and Technology Annual Meeting in Marco Island, Fla., will be able to see Complete Genomics' Genomic Discovery Software Partners demonstrating how to use their solutions with Complete Genomics data in the Complete Suite in the Everglades Room from 5-7 p.m. ET on Thursday, Feb. 16.
http://finance.yahoo.com/news/Complete-Genomics-Launches-pz-1490394475.html?x=0
Future Link & Business News
http://www.finviz.com/futures.ashx
Foreclosures on the Rise Again
After a year-long reprieve from rising foreclosures, the numbers are going up again.
http://www.cnbc.com/id/46401756
U.S. stock futures lower on Moody’s bank warning
Greek bailout remains in limbo
FRANKFURT (MarketWatch) — U.S. stock futures pointed to a slightly lower start for Wall Street Thursday after Moody’s Investors Service threatened to downgrade global banks, including Morgan Stanley, Goldman Sachs Group Inc. and J.P. Morgan Chase & Co., and the fate of a second Greek bailout remained unclear.
http://www.marketwatch.com/story/us-stock-futures-lower-on-moodys-bank-warning-2012-02-16?dist=beforebell
Investor 100
GNOM...Illumina Announces Favorable Patent Claim Construction Ruling in Litigation Against Complete Genomics, Inc.
SAN DIEGO--(BUSINESS WIRE)--
Illumina, Inc. (NASDAQ: ILMN - News) announced today that Magistrate Judge Elizabeth D. Laporte of the U.S. District Court for the Northern District of California issued a Claim Construction Order in the litigation brought by Illumina against Complete Genomics, Inc. Illumina has accused Complete Genomics of infringing U.S. Patent No. 6,306,597.
Judge Laporte’s February 8 Order provides the Court’s interpretation of the disputed terms in the patent asserted by Illumina. In its Order, the Court adopted constructions favorable to Illumina for the key terms in dispute. Illumina believes that the Court’s interpretations affirm the breadth of the patent and Illumina’s position that Complete Genomics infringes the patent.
“We are very pleased with the Court’s Claim Construction Order and look forward to proceeding with the remainder of the case,” said Jay Flatley, Illumina’s President and CEO. Illumina is seeking remedies including lost profits, a reasonable royalty and a permanent injunction.
Don't know how bad this is for GNOM.
GRVY..$2.38 Stock with a lot of momentum in the coming weeks & into Q2 based on several pending catalysts. Video Chart & DD link attached http://chart.ly/dh3oofr .
The main catalyst for Gravity is the Feb 22nd Beta Launch of Ragnarok 2. Bought a small position near the high of the day.
Tried to buy on pullbacks but was giving small amount of shares so ended up being a partial fill (20%) of what I wanted. Look to enter again tomorrow as it should move higher in weeks ahead due to their pending catalysts.
GRVY: Emil Chronicle @ FaceBook.
Here is the Facebook site for the game that GRVY is preparing to release on FaceBook.
Understand that this link is for players that play on other platforms around the world but meet on FaceBook as a community.
This is NOT the GRVY FaceBook game site BUt it still has 329,000 members.
Its safe to assume that they will rack up millions more players on FaceBook.
http://www.facebook.com/eco.indo
Note: My understanding is that this game is being formatted for as a mobile social game for the faceBook platform and a news rlease about it is due open release in Q2. Investors are urging GRVY to send out a pre-release PR as soon as possible touting this news.
ILMN- February 24th may be a big day for the entire sector if Roche ups the bid or pulls away. Either way it may generate a lot of buying in the sequencing space.
Illumina Board Rejects Roche’s $5.7 Billion Hostile Takeover
February 08, 2012, 3:27 AM EST
Illumina’s Board Rejects Roche’s $5.7 Billion Hostile Offer
By Sarah Frier
(Updates with comments from Illumina in eighth paragraph.)
Feb. 7 (Bloomberg) -- Illumina Inc.’s board unanimously rejected Roche Holding AG’s $5.7 billion hostile takeover bid for the maker of gene-mapping tools as “grossly inadequate.”
“The timing of the offer is blatantly opportunistic and does not reflect Illumina’s strong platform of new products and pipeline,” Chairman William Rastetter and Chief Executive Officer Jay Flatley said today in a letter to shareholders.
Roche went directly to shareholders of San Diego-based Illumina after the company rebuffed its approaches. Owners have until midnight New York time on Feb. 24 to tender their shares at $44.50 each, Basel, Switzerland-based Roche said last month. Illumina closed today at $51.80 and investors have signaled they expect Roche to raise its bid.
Roche, the world’s biggest maker of cancer drugs, said it wants to move Illumina’s gene-sequencing technology from academic research labs into routine medical use. The acquisition would build Roche’s palette of health diagnostics products and potentially allow the company to better target its medicines toward individual patients. Illumina said Jan. 10 that by the end of the year it would market a machine capable of scanning a person’s complete DNA in a day.
Silvia Dobry, a spokeswoman for Roche, didn’t immediately return a call seeking comment on Illumina’s action.
Illumina has bolstered its takeover defenses since Roche made its $44.50-a-share acquisition offer last month, granting investors the right to buy shares at half price, a so-called poison-pill maneuver. The strategy may block an unwanted bid by making it prohibitively expensive.
Illumina said Roche’s bid fails to recognize the growth potential from Illumina’s 60 percent share of the next- generation genetic sequencing market.
“Your proposal fails to compensate our stockholders for the intrinsic and scarcity value associated with Illumina’s unmatched leadership position,” Rastetter and Flatley wrote in a letter to Franz Humer, board chairman of Roche.
http://www.businessweek.com/news/2012-02-08/illumina-board-rejects-roche-s-5-7-billion-hostile-takeover.html
OT- Interesting article on investment banks, bio-tech, and buy-outs.
Dealpolitik: Filing by Illumina Highlights Complex Relationship With Goldman
The news from Illumina’s filing on Tuesday afternoon is not about Illumina at all. Of course, Illumina rejected the Roche $44.50 cash offer as grossly inadequate, etc. We were expecting that.
The interesting news is about Goldman (click here for a news story by Deal Journal colleague Gina Chon). The bank was hired as one of two financial advisers to Illumina despite having an enormous derivative position in Illumina stock that dwarfs the size of its advisory fee. The filing Tuesday shows that Illumina’s management and its board, in deciding whether to retain Illumina to advise it on Roche’s offer, considered Goldman’s interest in its stock at least four different times, including when Goldman proactively raised it on December 14 on its first call on the deal.
The board asked Bank of America Merrill Lynch to advise it (without Goldman present) on the nature of Goldman’s interest. After all of this, Goldman was retained, for among other reasons, its familiarity with Illumina, its work on the Illumina IPO and other transactions and its prior work in defending Roche hostile offers, according to Illumina’s filing.
In addition, Illumina also retained BofA to advise the board as well.
So what’s the story on the derivative position that generated this concern?
The transaction arose as a hedge to reduce potential dilution to Illumina’s stockholders of the convertiability feature of a 2007 note sale, the filing says.
In 2007, long before anyone was thinking takeover, Illumina issued a convertible note through Goldman and another bank with a conversion price of $21.83 per share. A convertible note is a loan that eventually can convert to an equity stake. Through a series of derivative transactions (and payments) with Goldman, Illumina was able effectively to increase that conversion price to $31.44 per share, a move that would reduce the number of shares it would have to issue were the price to rise. The convertible notes themselves have almost all been converted and that transaction is old and cold. But the derivative transactions with Goldman remain very much alive and kicking and a deal with Roche at the current offer would have a significant impact on who owes what to whom.
If Roche were successful with its current offer of $44.50 per share, Illumina says it would be required to pay Goldman $272.8 million for the cancellation of warrants issued in the transaction, the filing shows. To hedge its risk in the derivative transaction, Goldman sold short approximately 10.2 million shares of Illumina which would cost Goldman $454 million to close out if Roche closed its current deal. All this said, Goldman isn’t necessarily vested in a lower stock price for Illumina. Illumina does not disclose how a change in price would affect the payments.
Also, presumably the difference in payments was baked into the initial fees for the transaction of $139 million, Goldman of course received the proceeds from selling the shares short and Goldman may have had some other profits (or losses) over the years in connection with managing this hedged transaction.
And these payments are an acceleration of payments that would be due anyway when the transaction matures in 2014 if there is no Roche deal.
But whatever the payments, they appear to be sensitive to the price of Illumina stock. The numbers are large, and one can be very sure that the traders at Goldman understand exactly what effect the Roche deal has on their positions.
And this isn’t just some old deal now dormant. Illumina’s filing says Goldman is going to “continue to engage, in hedging and other market transactions with respect to its position.” In other words, Goldman can implement strategies in its trading to try to advantage itself as the deal develops.
In fairness, the filing indicates that Goldman, as is typical, “maintains customary institutional information barriers,” to ensure that those trading do not have access to the information that investment bankers at Goldman have. There is one other interesting feature of the retention of Goldman. In addition to getting paid a percentage (0.42%) of the transaction if there is a deal, and a fixed dollar amount ($17.7 million) if Roche is chased away from its current deal, all of which is typical, Goldman gets extra fees (up to an extra $2.3 million) if Roche bumps its offer but does not close. But BofA Merrill Lynch? It gets paid less across the board and gets no bonus if Roche bumps, but doesn’t close.
What’s the significance of all of this? The Goldman derivative interest is a bit embarrassing for Goldman and Illumina, but substantively I don’t think it would affect Goldman’s advice on Roche to the board. And BofA Merrill Lynch has been brought in to keep an eye on things even if there were to be an issue.
But here is where it could make a difference: Roche’s strategy to get its takeover done includes seeking to replace a majority of the Illumina directors. The amounts involved in the Goldman derivative position are so eye-popping that they could make great fodder for a proxy fight. Roche could try to make the case that Illumina’s directors are not being guided by disinterested judgment but by Goldman’s clouded judgment. Roche could try to create doubt among shareholders as to whether the incumbents can make the right decisions.
That proxy fight was going to be nasty anyway. Now Illumina seems to have handed Roche quite a nice issue on a silver platter. Illumina may still be able to convince shareholders that their directors are the best custodians for a sale process, but the Goldman issue will at least create a lot of smoke.
http://blogs.wsj.com/deals/2012/02/08/dealpolitik-filing-by-illumina-highlights-complex-relationship-with-goldman/?mod=yahoo_hs
downgrade of banks by MOODYS...
good read
http://finance.yahoo.com/news/moodys-may-downgrade-17-banks-003723628.html
gl
something to keep an eye on during this consolidation period.
NUAN
http://seekingalpha.com/article/370091-nuance-is-the-best-apple-in-the-bushel
gl
That's a lot of chips
GNOM- Earnings are due next month. It looks like they are anticipating growth in the careers section-
http://www.completegenomics.com/about-us/careers/operations/
OT- FDA Advisory Panel 101
By Brian Orelli, PhD | More Articles
February 15, 2012 | Comments (0)
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A reader asks, via Twitter: "Do you know why a company would choose to approach the FDA advisory panel vs. going direct to FDA for approval?"
This isn't an either/or situation. In fact, the company has zero say in whether an advisory panel is held. It's the FDA that sets up the panel of outside experts when the agency wants a little extra help deciding on an approval.
The advisory committee meeting consists of presentations from the company and the agency, and there's usually time for patients to speak as well. The meeting culminates with questions proposed to the committee of outside experts. The voting questions are just an advisory vote; there are plenty of examples of the agency going against the panel's vote, especially when the vote is in favor of recommending approval.
Advisory panels can help investors get a better read on the likelihood of approval, but make sure you don't just focus on the vote. The briefing documents prepared by the FDA for the committee members offer a good look at what the FDA is thinking, and the agency also considers the comments made by the experts during the advisory committee in addition to the final vote.
But what about drugs where the FDA doesn't schedule an advisory panel? Can you read anything into the lack of an advisory panel?
A big, fat maybe
If the FDA doesn't schedule an advisory panel, it seems safe to assume that the FDA is comfortable with making the decision on its own. Whether that means an approval or a rejection, however, depends on the drug. It's likely good news for companies with good data and bad news for companies with questionable data.
Amarin (Nasdaq: AMRN ) , for instance, said this week that the FDA had informed it that no advisory panel would be scheduled for AMR101. The treatment for high triglycerides passed two clinical trials. Both trials were conducted under a Special Protocol Assessment, so the FDA had already signed off on the trial design. An approval already seemed pretty likely; the lack of an advisory panel is just piling on top of those expectations.
Similarly Ironwood Pharmaceuticals (Nasdaq: IRWD ) and Forest Labs said earlier this month that the FDA wouldn't convene a panel to review their anti-constipation drug linaclotide. The drug underwent four phase 3 trials and more than 2,000 patients have been on it for at least a year, making its efficacy and safety profile fairly clear.
In general, the FDA is more likely not to bother with advisory panels for drugs that will be approved, but keep in mind that there's more to an approval than just the issues that would be reviewed by an advisory panel. Manufacturing issues, fine points of a REMS, and other issues can trip up an approval even when the clinical data looks pretty good.
Second time, same as the first
Most of the time drugmakers don't have to undergo an advisory panel meeting when they reapply for approval after receiving a complete response letter. The agency is, hopefully, confident enough with its rejection and the requirements to reverse the decision that it doesn't need any outside help.
Recently, though, a few drugmakers have had advisory panels scheduled to review their second applications. Again, considering them on a case by case basis is the best solution.
Cell Therapeutics (Nasdaq: CTIC ) had an advisory panel scheduled for its cancer drug pixantrone after the company appealed to the FDA higher-ups to ask that the data be reconsidered. At the first advisory panel meeting, the committee members voted unanimously to recommend rejection of the drug. Without substantially new data, it might be difficult to convince a new panel to offer a different opinion. Cell Therapeutics is hoping a little more time will help; last month, it withdrew its application to get the advisory panel rescheduled.
Two obesity drugs, VIVUS' (Nasdaq: VVUS ) Qnexa and Arena Pharmaceuticals' (Nasdaq: ARNA ) lorcaserin, are back in front of the FDA after being rejected a little over a year ago. Both will get a second look from an advisory panel as well. VIVUS' meeting is next week on Feb. 22 and Arena expects its meeting to be held in the second quarter.
These are a tough call, considering the controversy around obesity drugs. While you could interpret the second advisory panel as a sign the companies didn't satisfy the FDA requirements, I think it's possible the FDA might be looking for a little backing from the experts to justify approving the drugs.
http://www.fool.com/investing/high-growth/2012/02/15/fda-advisory-panel-101.aspx
GRVY..$2.38 Solid DD on this one. Good heads up & very well done. Definitely on my radar moving forward. Tomorrow's trading will be interesting. They have several catalysts w most pending being launch of gaming app Feb 22 then two Facebook apps in Q2. Also a profitable company as well. I like the low float on the stock. Has been dormant for months but it wont be for long.
HZNP..$3.90 Thanks for the heads up on this one. Looks like a low float play with a pending PDUFA. Trading well under book value. I will check it out!
ECYT..$3.84 Soros Fund Largest Purchases in 4Q http://www.nasdaq.com/symbol/ecyt/institutional-holdings/new
nice update news on NYMX nehttp://ih.advfn.com/p.php?pid=nmona&article=51210161&symbol
IBIO background overview as filed in 10k
http://biz.yahoo.com/e/120214/ibio10-q.html
iBio, Inc. ("iBio" and the "Company") is a biotechnology company focused on commercializing its proprietary technology, the iBioLaunch? platform, for biologics including vaccines and therapeutic proteins. Our strategy is to promote our technology through commercial product collaborations and license arrangements. We expect to share in the increased value our technology provides through upfront license fees, milestone revenues, service revenues, and royalties on end products. We believe our technology offers the opportunity to develop products that might not otherwise be commercially feasible, and to work with both corporate and government clients to reduce their costs during product development and meet their needs for low-cost, high-quality biologics manufacturing systems. Our near-term focus is to establish business arrangements for use of our technology by licensees for the development and production of products for both therapeutic and vaccine uses.
Vaccine candidates presently being advanced on our proprietary platform are applicable to newly emerging strains of H1N1 swine-like influenza, and H5N1 avian influenza, yellow fever, malaria, and anthrax. Therapeutic candidates presently being advanced on our proprietary platform include human alpha-galactosidase A for the treatment of Fabry disease, human C1 esterase inhibitor for the treatment of hereditary angioedema (HAE), human alpha-1 antitrypsin for treatment of disorders caused by a lack or deficiency of alpha-1 antitrypsin, a therapeutic vaccine for human papilloma virus (HPV), and several other therapeutic protein targets for which preliminary product feasibility has been demonstrated.
In order to attract appropriate licensees and increase the value of our share of such intended contractual arrangements, we engaged the Center for Molecular Biotechnology of Fraunhofer USA, Inc., or FhCMB, in 2003 to perform research and development activities to develop the platform and to create our first product candidate. We selected a plant-based influenza vaccine for human use as the product candidate to exemplify the value of the platform. Based on research conducted by FhCMB, our proprietary technology is applicable to the production of vaccines for any strain of influenza of H1N1 swine-like influenza. A Phase 1 clinical trial of a vaccine candidate for H1N1 influenza, based on iBio's technology, was initiated in September 2010. We announced positive interim results in June 2011. The vaccine candidate demonstrated strong induction of dose correlated immune responses, with or without adjuvant, as assessed by virus microneutralization antibody assays and hemagglutination inhibition ("HAI") responses. The vaccine was safe and well tolerated at all doses when administered with and without adjuvant.
In connection with the research and development agreement, FhCMB agreed to use its best efforts to obtain grants from governmental and non-governmental entities to fund additional development of our proprietary plant-based technology. Consequently, in addition to the funding we have provided, FhCMB has received funding from the Bill & Melinda Gates Foundation for development of various vaccines based upon our proprietary technology including an experimental vaccine for H5N1 avian influenza. A Phase 1 clinical trial of a vaccine candidate for H5N1 influenza, based on iBio's technology, was initiated in December 2010 and is ongoing. The results of this trial are expected to be released during the first half of calendar year 2012.
In addition to the platform and product development engagements, in 2006, the Company engaged FhCMB to create a prototype production module for products made through the use of the platform. The purpose of this engagement was to demonstrate the ease and economy with which platform-based products could be manufactured in order to attract potential licensees and increase the value of our share of such business arrangements. The prototype design, which
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encompasses the entire production process from the seeding through pre-infiltration plant growth, infiltration with agrobacteria, harvesting of plant tissue and purification of target proteins, was completed in May 2008. A pilot plant based upon this prototype was subsequently constructed in the FhCMB facility in Newark, Delaware. This pilot plant, and the equipment in it, are owned by FhCMB and have been validated for cGMP (current good manufacturing practice) production. It is anticipated that it will be used for cGMP production of protein targets for clinical trials of product candidates utilizing our platform technology.
In January 2011, we announced the grant of a commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos of Brazil to develop, manufacture and sell certain vaccines based upon our proprietary technology. Fiocruz/Bio-Manguinhos will invest $6.5 million to bring the first product candidate, a yellow fever vaccine, through a Phase I clinical trial. Yellow fever is a viral infection in the group of diseases known as hemorrhagic fevers. The virus is transmitted by mosquitoes, and is common in South America and sub-Saharan Africa. The disease, which causes fever, nausea and pain, varies in severity, but is frequently lethal when it progresses to bleeding or to liver damage. The World Health Organization has estimated that 200,000 unvaccinated people contract yellow fever each year, and approximately 30,000 die from the disease.
Development of the yellow fever vaccine candidate will be performed through a commercial collaboration among the Company, Fiocruz/Bio-Manguinhos, and FhCMB. The license covers the nations of Latin America, the Caribbean and Africa. The Company retains the right to sell the products developed under the license and collaboration agreement in any other territory with a royalty back to Fiocruz/Bio-Manguinhos. Bio-Manguinhos is a unit of the Oswaldo Cruz Foundation (Fiocruz), a central agency of the Ministry of Health of Brazil.
Fiocruz/Bio-Manguinhos produces and develops immunobiological items to respond to public health demands. Its product line consists of vaccines, reagents and biopharmaceuticals. Fiocruz/Bio-Manguinhos is a leading company in the national export of human vaccines and a major participant in total export sales of the Brazilian pharmaceutical sector. Fiocruz/Bio-Manguinhos is one of the main producers of vaccines and diagnostics for infectious diseases in Latin America. Fiocruz/Bio-Manguinhos is a certified World Health Organization provider to United Nations agencies, and is a leading world manufacturer of yellow fever vaccine, which it has exported to over 60 countries.
The Company established non-commercial arrangements among the Company, certain government entities, a non-governmental organization ("NGO") and FhCMB, pursuant to which the Company grants non-commercial rights to use its platform for the development and production by FhCMB of product candidates selected by the government entities and the NGO, in consideration for grants by the government entities and the NGO directly to FhCMB to fund such research and development.
Through (i) the Company/FhCMB contracts and (ii) the non-commercial arrangements described above (which we refer to collectively as the "business structure"), the Company retains ownership of the intellectual property and exclusive worldwide commercial rights in the fields of human health and veterinary influenza applications of the intellectual property. The Company licenses or otherwise grants use rights (a) to government and NGO entities for not-for-profit applications of the intellectual property for the development or application for which they granted or were granted funding, and (b) to FhCMB for research purposes and applications in other fields.
This business structure helps the Company to enhance the value of commercial rights and the scope of applications of its platform technology. It also helps the Company demonstrate the validity and apparent value of the platform to parties to whom it will offer licenses or other business opportunities. Outsourcing our research and development work allows us to develop our product candidates, and thereby promote the value of our platform for licensing and product development purposes, without bearing the full risk and expense of establishing and maintaining our own research and development staff and facilities. FhCMB is engaged to perform research and development for the yellow fever vaccine project based on their expertise. The expected contract with FhCMB is expected to be $6.5 million. Service revenues and research expense under this arrangement commenced in February 2011. The amount billed for revenues and this agreement and related research and development expenses for the three and six months ended December 31, 2011 were approximately $234,000 and $554,000, respectively.
The Company's platform technology is sometimes referred to as "iBioLaunch? technology" or the "iBioLaunch? platform," and the category of this technology is sometimes referred to as "plant-based technology" or as a "plant-based platform." The Company has exclusive control over, and the rights to ownership of, the intellectual property related to all human health and veterinary influenza applications of the plant-based technology developed by FhCMB. Current
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development projects include conducting proof-of-principle preclinical studies and conducting clinical studies of proprietary influenza vaccines. Many biotech drugs have been on the market long enough for patents on them to expire. Emerging opportunities for biosimilars (also known as biogenerics or follow-on biologics) create potential for our platform technology to be used by potential licensees to enter the market utilizing what the Company expects to be an economical production system. The Company is seeking commercial partners for this category of products and is unlikely to develop products in this category without the financial and marketing support of a commercial partner.
Our current product candidates are in the preclinical or early clinical stage of development and will require significant further research, development, clinical testing and regulatory clearances. They are subject to the risks of failure inherent in the development of products based on innovative technologies. These risks include, but are not limited to, the possibilities that any or all of these products will be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances; that these products, although effective, will be uneconomical to market; that third parties may now or in the future hold proprietary rights that preclude us from marketing them; or that third parties will market superior or equivalent products. Accordingly, we are unable to predict whether our research and development activities will result in any commercially viable products or applications. Further, due to the extended testing and regulatory review process of these product candidates required before marketing clearance can be obtained, we do not expect to be able to commercialize any for at least several years, either directly or through our current prospective partners or licensees. There can be no assurance that our product candidates will prove to be safe or effective or receive regulatory approvals that are required for commercial sale. Historically, in addition to the development of the platform technology described in the preceding paragraphs, the Company has also generated sales of nutritional supplements utilizing plants as sources of high-quality nutritional minerals.
The Company has a patented process for hydroponic growth of edible plants that causes them to accumulate high levels of important nutritional minerals such as chromium, selenium, iron and zinc. The Company utilized the services of various wholly-owned subsidiaries of our former parent company, Integrated BioPharma, Inc. ("Integrated BioPharma" or "Former Parent") to support the production, marketing and sales of these phytomineral products.
THLD starting to move again. Phase 2 results out any day.
GAZ another big day. Up 30%+ for the week, so far..
Link back for charts.
GRVY: Mobile social game roll out underway. LINK
New Website: http://ro2.gnjoy.com/
RO2 official trailer:
ARIA:ARIAD Announces Issuance of Key U.S. Patent on Ponatinib
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) today announced that the United States Patent and Trademark Office has granted U.S. Patent No. 8,114,874 entitled, “Substituted Acetylenic Imidazo[1,2-B] Pyridazine Compounds as Kinase Inhibitors,” which provides composition-of-matter patent protection through at least December 22, 2026 for ARIAD’s investigational pan-BCR-ABL inhibitor, ponatinib. This new patent covers both the compound itself and its pharmaceutical compositions. Additional patent applications covering ponatinib in the U.S. and in other countries are pen
http://finance.yahoo.com/news/ARIAD-Announces-Issuance-Key-bw-2113855515.html?x=0
Investor 100
Future Link & Business News
http://www.finviz.com/futures.ashx
U.S. stock futures up; data, earnings in focus
Zynga, Comcast active in pre-open trade
MADRID (MarketWatch) — U.S. stock-market futures were pointing to a positive start for Wall Street on Wednesday, after overnight words of encouragement from China’s central-bank governor to Europe, with shares of Comcast Corp. and Zynga Inc. active in pre-open trading as a clutch of data await
http://www.marketwatch.com/story/us-futures-up-china-data-earnings-in-focus-2012-02-15?dist=beforebell
Europe Crisis Will Take Years to Sort Out: Paulson
Although there are similarities with what the United States went through at the onset of the financial crisis, the issues in Europe are more complex and will take years to resolve, Henry Paulson, former Treasury Secretary and founder of the Paulson Institute told CNBC on Wednesday.
http://www.cnbc.com/id/46394761
Kellogg's buying Pringles for $2.7 billion
NEW YORK (CNNMoney) -- Procter & Gamble has found a new buyer for its Pringles unit, as cereal maker Kellogg Co. will pay $2.7 billion for the distinctively shaped potato chip product
http://money.cnn.com/2012/02/15/news/companies/pringles_kellogg/index.htm?iid=HP_LN
Investor 100
ECYT..$3.78 DD Post on a bottom play. 52wk low is $3.02 & 52wk high is $14.80. It hit $5.50 yesterday on positive news. Was a bottom play that was trading below cash & book value. ECYT is in the same position here. February is ECYT month as they have 3 investor conferences in February alone. The market cap for ECYT (Endocyte) is only 135 million. There are 27m shares in the float & 35m shares outstanding. They also have 138m in cash which is more than the market cap for the company. Over 50% of O/S is held by institutions.
Short Interest was 31% higher as of latest report. http://bloom.bg/xoJVZ8 Largest Nasdaq Short Interest Percent Increases as of Dec. 30
Leerink Swann 2012 Global Healthcare Conference - Wednesday, Feb. 15, at 8:30 a.m. EST. The conference will be held at the Waldorf=Astoria in New York City.
Citi 2012 Global Health Care Conference -- Monday, Feb. 27, at 3:00 p.m. EST. The conference will be held at the Waldorf=Astoria in New York City.
2012 RBC Capital Markets' Global Healthcare Conference --
Tuesday, Feb. 28, at 9:30 a.m. EST. The conference will be held at the New York Palace in New York City.
Investment Conferences in February. I expect upgrades from these conferences and can bring new money into ECYT.
http://yhoo.it/woAf7L
Instututional Buying in February- 13G Pension Fund of the Christian Church 9.5% of the O/S on 2/6/12 http://bit.ly/wXveY3
Other Financials including most recent Form 4's can be found at this link. http://www.otcmarkets.com/stock/ECYT/financials
Endocyte Company Presentation Jan 2012 -http://bit.ly/xL5x2m
GRVY games and FaceBook launch. Q2, 2012.
Strong news to know.
GRVY: Too release games on FaceBook in Q2,2012.
The games will the subject of news releases when it happens.
Dear XXXXXXXXX, Feb,15, 2012
We understand the huge interest of the U.S. investment community in Facebook as well as games on it. While we are going to release Requiem and Emil Chronicle Online on Facebook in 2012, please kindly be informed that Requiem and Emil Chronicle Online are our MMORPGs commercially offered in some markets since several years ago (Requiem is currently serviced 84 markets and Emil Chronicle Online is in 4 markets) though the revenues from them are not quite substantial, which means Gravity is not developing brand-new games on the Facebook platform and we are ‘converting’ the games in order that they can be played on Facebook and the Web (www.warpportal.com).
Since the two games on Facebook will be published by Gravity Interactive, Gravity’s wholly-owned subsidiary in the U.S., Gravity Interactive will distribute press releases in the U.S. before each game is launched. The launch dates have not been finalized yet but it is likely that one or both of the games will be released on Facebook in the second quarter of this year.
Should you have any further questions, please let me know.
Thank you.
Kind regards,
Yoon Joo LEE
IR Manager
Gravity Co.,
BPAX - .98
Out AH at $1.02 - $1.01
Thanks for the heads up on this Burp Much appreciated sir
BPAX - .95 AH -
Thanks for the heads up - i'm in for a small position at .92 - could see a short squeeze tomorrow -
Related News:Science · U.S. · Health Care Teva, BioSante Win U.S. Approval for Testosterone Therapy
QBy Molly Peterson - Feb 14, 2012 3:55 PM CT inShare0More
Business Exchange Buzz up! Digg Print Email Teva Pharmaceutical Industries Ltd. (TEVA) and BioSante Pharmaceuticals Inc. (BPAX) won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men.
The Food and Drug Administration approved the transdermal gel, the agency said today in an e-mail. Teva, of Petach Tikva, Israel, will market Bio-T-Gel for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.
BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.
Abbott Laboratories (ABT) won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the
PACB- Pacific Biosciences Releases Next Generation Chemistry and Software for PacBio® RS DNA Sequencing System
Fifty Presentations and Posters Will Describe Results Generated with Single Molecule Real-Time Technology at This Week’s AGBT Conference
Business WirePress Release: Pacific Biosciences of California, Inc. – Mon, Feb 13, 2012 7:30 AM EST
MENLO PARK, Calif.--(BUSINESS WIRE)--
Pacific Biosciences of California, Inc. (NASDAQ: PACB - News), provider of Single Molecule Real Time (SMRT®) sequencing products, today announced it has released a major upgrade to its PacBio® RS system, referred to as “C2”, including new chemistry, enhanced SMRT Cells and upgraded software, which together provide customers with significant performance increases for DNA sequencing. The company and numerous customers will discuss their progress with the platform through a total of 50 presentations and posters at the 2012 Advances in Genome Biology & Technology (AGBT) meeting this week in Marco Island, Fla.
http://finance.yahoo.com/news/Pacific-Biosciences-Releases-bw-3556712115.html?x=0
Driving Biomedical Information-FDA Policies Booklet
http://1.usa.gov/wWwwvW
CYTR...$.328 It got to .375 yesterday as well as today but could not hold it. Sold my position b/w .365 and .36 for little gain. They had their presentation today but it could not sustain any gains that it had over the past 3 trading days.
AFFY..$10.96 Traded well today. Took profit here at $11.20 on AFFY from $7.70 entry on 1/31. It broke below $11.30 twice today only to rebound. When market turned south again it was time to lock in profits from $7.70. The presentation was a nice catalyst for today but the price just could not hold. Will look to re-enter closer to the PDUFA date. Was a solid play for the board!
Trimel Pharmaceuticals' Female Sexual Dysfunction Program Achieves Key Milestones
- Results of TBS-2 Phase II Vibrotactile Stimulation study yield positive outcomes for all Anorgasmia parameters
- Company to initiate multinational TBS-2 Phase II Ambulatory clinical program
- Dialogue with the United States Food and Drug Administration together with qualitative patient research has produced refined selection criteria and efficacy metrics for TBS-2 Phase II Ambulatory study
-TEFINA(TM) filed with United States Patent and Trademark Office as TBS-2 trade name
TORONTO, ONTARIO--(Marketwire -02/14/12)- Trimel Pharmaceuticals Corporation (TSX: TRL.TO - News) ("the "Company" or "Trimel") today announced the achievement of key milestones furthering the development of its no-touch bioadhesive intranasal gel product Tefina (TBS-2) for the treatment of Female Anorgasmia:
Tefina™ Phase II Vibrotactile Stimulation Study (VTS) Results
The Company announced today that the results from the Vibrotactile Stimulation (VTS) study demonstrated that Tefina had successfully met all study endpoints.
The VTS study measured the occurrence of, time to reach, and the quality of the orgasm, as compared to placebo. On the key metric of achieving orgasm, the results indicate that the separation between placebo and active drug demonstrates a significantly positive finding for Tefina. The VTS study further investigated improvements in the key measures of sensuality, sexual arousal and genital sensation. For all the metrics listed, Tefina again demonstrated a meaningful separation from placebo.
Tefina™ Phase II Multinational Ambulatory (AMB) Study.
Given the successful outcome from the VTS study, the Company expects to move expeditiously to implement its second Phase II study of Anorgasmia. This upcoming clinical study will be one of the largest to ever explore a "use as required" treatment for women experiencing any form of Anorgasmia.
Tefina™ Regulatory Update
Based on a cooperative dialogue with the US Food and Drug Administration (FDA), the Company has executed an extensive qualitative research program with women experiencing Anorgasmia. The findings of this research has provided supportive evidence that has been integrated into the patient selection and endpoint measurement criteria that will be implemented in the Phase II AMB Study.
TBS-2 Tradename - Tefina™
The application to the United States Patent and Trademark Office for the trademark "Tefina" underscores the Company's belief in trade marking a product once it has demonstrated safety and efficacy through a Phase II trial.
Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel, offers the following comments "The positive conclusion of the Phase II VTS study along with its predecessor programs denotes ground breaking support for our decision to pursue a "use as required" product for women experiencing Anorgasmia. These pioneering insights in female sexual health, where to date no "use as required" product has been approved, gives even greater importance to our corroborative effort with the FDA to improve diagnostic criteria and assistive measurements for implementation in our Phase II AMB study. Implementing these principles is expected to provide a more efficient continuum along the pathway to product approval.
ECYT..$3.80 DD post will be forthcoming on this play. Established a position at $3.72 today. February should be a solid month here for them as they are a bottom play indeed. 1.2m in volume today shows the market is giving them notice.
GNOM.. Anyone still in GNOM, dont know if today price action is profit taking , I felt this was under valued, and had room to run, even Sheff said this would be over 4 soon, I guess earning next month and deal with Mayo could send this higher.
I cashed out all yesterday at 4.90 but bought back today at 4:30 :)
Good luck
GQ
ECYT..$3.77 Could close strong today. Excellent day of trading here with several investment conferences scheduled for the month of February. February could actually be the month of recovery for this beaten down biotech play.
AFFY..$11.30 Moving back up here. Lots of volatility in this stock today on a presentation day.
ECYT..$3.82 It is now heating up here on a down market day. Strong volume coming in now.
ECYT looks like Three presentations this month.Feb 15th,27th,28th: yhoo.it/wkFrD7
Follow Me on Twitter: http://twitter.com/SheffStation/
New Economy Portfolio: Larger Cap stocks for slower but more consistent gains. Some Longer-Term Plays (30-60 days maybe longer)
Beginner Portfolio: Scalp Plays & Low Float Biotechs for potential explosive Growth. Quick Turnover 1-30 days (smaller balance want aggressive growth)
Position Size: STARTER: (1-5% Portfolio Balance) SOLID: (6-10% Portfolio Balance) FULL : (11-20% Portfolio Balance)
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$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:
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