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just an interesting post to take a note of, and for lazy pontification.
George Soros Portfolio based on feb 14, 2012; 13F filing.
https://ycharts.com/topics/george_soros_portfolio
gl
RGEN..$4.69 Repligen to Present at Cowen and Company Health Care Conference -March 7th 10:40am est http://yhoo.it/x5oEDR
TLON..$.90 I mention in my post that for enrollment of Talon's confirmatory trial that Talon is waiting for a 3rd-6th line patients. The patient population for the confirmatory trial is different than the RALLY study. The Phase 3 study is for patients 60 years or older with newly diagnosed ALL. I wanted to clarify as I was not clear in my earlier message that these are two separate trials. I am still awaiting the first patient enrollment from the HALLMARQ study.
Talon states that the Phase 3 confirmatory trial (Hallmarq) primary objective is:
"To compare overall survival (OS) among subjects 60 years of age and older with newly diagnosed ALL who receive Marqibo versus standard vincristine as a component of multi-agent induction, intensification, and maintenance chemotherapy. The study is powered for superiority."
TLON..$.90 Advisory Committee Calendar March 21, 2012: (ODAC) Oncologic Drugs Advisory Committee Meeting Announcement: http://1.usa.gov/Aq67MN
Sector Snap: Generic competition and biotech drugs: http://dlvr.it/1GnYQk
$ZGNX: Look for huge YoY sales growth in pending earnings report. Rated strong buy by 5 out of 5 analysts.
AEZS/KERX. Article link .FDA Approval Pratically A Done Deal For Keryx And AEterna Zentaris. (no position currently Careful chasing in the AH they spiked already, I would wait for a pullback. imo).
http://seekingalpha.com/article/408841-fda-approval-pratically-a-done-deal-for-keryx-and-aeterna-zentaris?source=kizur
EGT: Entertainment Gaming Asia. New pics.
http://www.elixirgaming.com/CasinoPailin_2012-02.html
NOTE: Earnings CC and live webcast on 3/8/2012.
Thanks for your feedback i also still in!
Optimistic article on AFFY
http://finance.yahoo.com/news/affymax-rises-analyst-view-anemia-180307883.html
DNDN--holding 95% of my original shares---not something to brag about, from as far back as 2001.
New CEO, new focus on lowering COG, expected greater usage by large urology groups as they get comfortable with reimbursement and administration of drug.
New 2-3 quarters are KEY to regain revenue growth and Wall Street's confidence. I am holding and buying under $11.
$DNDN - Interesting SA - Why I Remain Positive On Dendreon
http://seekingalpha.com/article/407861-why-i-remain-positive-on-dendreon
GRVY..$2.62 Just because SA article does not mean GRVY will move. They promised shareholders they would deliver on a specific date and failed on that promise. It was a trade with potential that still has potential if the CEO steps up. I am leery until I see different. Good luck.
TLON..$.86 This is the data from the RALLY study that the FDA will be reviewing at the Advisory Panel Mtng. I believe that Dr. Susan O'Brien, M.D. Anderson, will be present to make a strong case for Marqibo approval. Advisory Panels are always risky and can make or break a stock most of the time. I am a risk taker and like what I have seen from Talon which is why I will continue to hold my position. I don't have a large position but will add if I like the AdCom notes and definitely if there is a positive panel review. If a positive review, then chance for approval is much greater. Two more weeks left till the notes are released. To invest a lot of money just for risk sake is not a wise move. Invest here what you can afford to lose but don't swing for the fences without all the information to increase the odds of success. A small position (what you can afford to lose) is always best. For larger there are other biotech plays to put more money into with less risk. Just my two cents there. The reward is high here but also the risk. Big money with Warburg Pincus & Deerfield is in this company & I like that. I would like to see a patient enrolled in the confirmatory Phase III study (MARQIBO) as well before the AdCom Mtng. That would be a huge plus for Talon as well as members of ODAC. Talon has increased the enrollment sites but they are just waiting for that patient. Hard to find in 3rd-6th line which is why it is viewed by FDA as rare & unmet need. The trial is initiated so that is a positive but patient enrollment would be huge.
I will continue to post solid DD over next few weeks on this company moving forward so that one can make a best case decision based on the DD.
http://files.shareholder.com/downloads/HNAB/1689720077x0x527738/52FECA95-2084-4153-9AA8-7BD84FD3FCA8/ASH_poster_2011v2_final.pdf
RGEN..$4.66 Good report from LifeSci Advisors from 2/28. Has some good in depth information on the company.
http://bit.ly/
GRVY: via SeekingAlpha.
Imo, this is going to get big play.
Last SA moved it 50%.
http://seekingalpha.com/article/407471-gravity-has-game
PLX..$5.40 With a PDUFA date of May 1st, we know that it will start to catch fire here sooner rather than later. This price here continues to be attractive for entry.
RGEN..$4.66 Busted through $4.65 on low volume on a down market day. There had been a lot of resistance at that level so that is a positivel $5.00 is the next level I see ahead.
AFFY..$10.79 Almost crossed $11 today. With 3 wks left till their PDUFA, the volume has been strong the past few months.
$GTXI - massive block @ 3.30, 200k + shares...I continue to nibble in anticipation of Ostarine approval. Citi valued Ostarine alone @ $11/shr.
RENN pre-market is on fire.
http://ih.advfn.com/p.php?pid=nmona&article=51454554&symbol=RENN
gl
trip advisor is another web based review site for people to hammer or praise your business without any recourse.
why yelp will fail is they have a filtration system that almost knocks off every positive review your business gets unless its from a contributer that has multiple reviews.
then they email you every week with a "this is how many page views your business had WITHOUT advertising...
its a scam
unfortunately, the hedge funds will own all the short shares much like they do with groupon....so reatil wont be able to get in on the feed...
here is an example of trip advisor and a little spam :) much more objective and this is why IMHO they will bury yelp...
[url]http://www.tripadvisor.com/ShowUserReviews-g34675-d418168-r86559049-Cabo_s_Island_Grill_Bar-Tallahassee_Florida.html[/url
RGEN..$4.63 Traded 613,000 in volume for month of February. Traded 108,000 today on March 1st. Its already 1/5 of the way to the total volume of February. Once this gets volume it will break its 52wk high of $4.91 rather easily and get to $6 in no time. March should be a solid month as the volume continues to move higher.
What do you mean trip advisor is one, just curious.
was not very impressed with groupon, though yelp may be target for a good short. but like the long term potential.
Its going to be interesting how Goldman plays there 1.1 million shares! Its an interesting arrangement.
gl
i own an restaurant and can honestly say yelp is a scam.
trip advisor is the one. urban spoon #2
its too bad there will be no shares to short.
there were none for groupon either. another scam that cant find business to do it twice because its a rip off too
could of retired shorting groupon .such sure thing.
same thing is going to happen with yelp. watch
YELP:
http://dealbook.nytimes.com/2012/03/01/yelp-prices-its-offering-at-15-a-share/
should be interesting opening.
Yelp Prices Its Offering at $15 a Share
By EVELYN M. RUSLI
Spencer Platt/Getty ImagesYelp’s market debut will be another critical test of investor appetite for technology stocks.
Yelp, the online hub for local business reviews, priced its initial public offering at $15 a share on Thursday, above its expected range, according to people briefed on the matter.
At that price, the company has raised $107.25 million, at a $898.1 million valuation. Its market debut, set for Friday morning, will be another critical test of investor appetite for technology stocks, ahead of Facebook’s multibillion-dollar I.P.O. expected later this year.
At a market value of $898.1 million. Yelp will be trading at a high multiple, at more than 10 times revenue. Still, the valuation is slightly lower than earlier estimates, reflecting concerns about the market and Yelp’s business model. The start-up, which attracts some 66 million users per month, has a huge inventory of local business pages and user-generated reviews, spanning markets in North America, Western Europe and Australia. The service is free for consumers but local businesses pay to advertise on the site and to add premium features to their Yelp pages.
In 2011, the company generated $83.3 million in revenue and a net loss attributable to common shareholders of $16.9 million.
And that’s the rub with Yelp. Founded in 2004 in San Francisco, the company is still not profitable.
In its most recent prospectus, the company acknowledged that it has “incurred significant operating losses” and warned that its revenue growth will slow as its business matures, while its costs are expected to increase. A lack of profits is far from an anomaly in the Internet sector, but Yelp is facing increasing pressure from upstarts and giants like Google. The Internet company — which has, at times, prioritized its content over Yelp’s– recently bought Zagat, another popular aggregator of reviews and business ratings. In its filing, Yelp noted that Google is its “most significant source of traffic.”
Though demand is expected to be high for Yelp’s debut, many investors are still skeptical.
“The revenues are excellent right now, but their losses are high,” said Scott Sweet, a managing partner of IPOboutique.com, an I.P.O. advisory firm. “My primary concern is the current competition and the new players that will enter this space.”
The equity markets have been choppy for technology offerings, though more stable compared to the second half of last year. On Thursday, GCT Semiconductor, a maker of wireless chips, postponed its offering.
Meanwhile, Demandware, an enterprise software business, pushed ahead with its I.P.O. plans, setting its price target at $12.50 to $14.50 per share, putting it on track to raise about $74 million at the mid-point of the range. Angie’s List, another online reviews site that went public last November, rose nearly 1 percent on Thursday to close at $16.12, about 24 percent above its offering price.
Yelp’s largest shareholders, including Jeremy Stoppelman, the company’s chief executive, will not sell any shares in the offering. The sole entity selling shares is the Yelp Foundation, the company’s nonprofit arm, which plans to sell 50,000 shares in the I.P.O. Yelp’s largest venture capital backers, Bessemer Venture Partners, Elevation Partners and Benchmark Capital Partners, own roughly 60 percent of the company, with Bessemer and Elevation each holding a 22 percent stake.
According to its prospectus, Yelp plans to use the proceeds from the I.P.O. for general expenses, including sales and marketing activities, and for acquisitions or technologies that complement its business.
Its shares will trade on the New York Stock Exchange under the ticker “YELP.”
For its offering, Yelp is selling 7.15 million shares. But its underwriters, led by Goldman Sachs, Citigroup and Jefferies, have the option to sell an additional 1.1 million shares, based on demand.
gl
TBOW: Heads up .Possible breakout.
Over 2.00 now.
Gonna hit some screens.
RGEN..$4.55 Many Upcoming Expected Milestones in 2012. Market cap of only 140m Will be a busy year for them & should continue to be a good year for the stock. Bolded the two most crucial milestones.
Near-Term Milestones
- 1Q 2012 – Submit SecreFlo™ Marketing Authorization Application in Europe
- 1Q 2012 – Enroll first patient in RG2833 Friedreich’s ataxia Phase I study in Italy
- 2Q 2012 – Interim data on SecreFlo™ pilot study to improve diagnosis of pancreatic cancer
- 2Q 2012 – Complete integration of Novozymes Biopharma AB
- 2Q 2012 – Report results of RG3039 Phase I study for Spinal Muscular Atrophy
- 2Q 2012 – Present SecreFlo™ Phase III data at Digestive Disease Week (DDW)
- June 21, 2012 – SecreFlo™ PDUFA date with priority review
- 2H 2012 – Launch SecreFlo™ in the US pending FDA approval
- 2H 2012 – Initiate pediatric studies of SecreFlo™
Company has zero debt & 50m in cash. $1.62 cash per share & $2.21 book value per share. Only 30m shares outstanding and only 40m authorized. Little chance of dilution and if so it can only be to 40m unless authorized by board of directors to increase the authorized. Only 26m shares in the float. Almost 40% held by institutions. 3m avg volume of only 35,000 shares. This should get more attention in the coming months.
Clinical Basis for SecreFlo™ NDA
The SecreFlo™ NDA was submitted to the FDA based on positive outcomes from the re-read of the Company’s Phase 3 clinical study. This pivotal study was a multi-center, baseline controlled, single dose study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each patient
in the study received an MRI of the pancreas with and without SecreFlo™, and separately underwent endoscopy (ERCP) as a diagnostic reference. The MRI images were randomized and independentlyread and reviewed by three central radiologists.
The Phase 3 study re-read demonstrated that all endpoints were met with statistical significance, and that SecreFlo™ was safe and well tolerated. The study’s co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts
with minimal loss in specificity by two of the three central radiologists reading the MRI images. The study met its primary endpoints, demonstrating that the addition of SecreFlo™ to MRI resulted in a highly statistically significant improvement (p<0.0001) in sensitivity of detection of ten prespecified
abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All three secondary endpoints were also met, with each demonstrating highly statistically significant improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone. A radiologist’s ability to more confidently identify and characterize pancreatic duct abnormalities has the potential to substantially improve “next-step” clinical decisions
(patient triage) and patient outcomes. SecreFlo™ was previously granted Fast Track designation by the FDA and also has Orphan Drug
status, which qualifies Repligen to receive seven years of U.S. marketing exclusivity for SecreFlo™, if approved. In addition to it’s U.S. application for approval of SecreFlo™, the Company plans to file a marketing authorization application (MAA) during the first quarter of 2012 for potential approval of SecreFlo™ in the EU.
ALXA..$.63 One I am keeping an eye on even if it is just for a potential trade into their PDUFA date. I don't own any of it. Been watching the Form 4's. Even though the buying is indirect, it has been consistent in the .50 cent range.
ALXA
Any thoughts on this one going forward $heff? Looking at your past trades it looks like you liked it at one point but took a small loss on it.
The advisory panel voted in favor of approval back in December. There is some internal turmoil within the company with directors leaving and staff being laid off.
EXAS..$9.40 Continues to be a solid performer since beginning of the year. Started the year around $8/share.
$CIGX Star Scientific Announces Notice Of Allowance By US PTO Granting New Patent Claims Relating To Tobacco Curing Technology >CIGX
http://www.dailymarkets.com/stock/2012/03/01/star-scientific-announces-notice-of-allowance-by-us-pto-granting-new-patent-claims-relating-to-tobacco-curing-technology/
RGEN..$4.49 Moving higher here on low volume again. This has not had its run since receiving priority approval for their drug. It will move higher on low volume each day.
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.
AFFY..$10.30 Solid PDUFA play. Company is under $400m market cap with 115m in cash. Company de-risking from the AdCom Panel with a 15-1 vote in favor. Should be trading close to $12 before PDUFA date & undervalued at the current level IMO.
Check out MOD, Modine Mfg. Huge contracts with CAT and extremely undervalued.
ONXX..$38.32 Target enrollment reached for the ASPIRE trial, evaluating carfilzomib + lenalidomide/ dexamethasone in pts with relapsed multiple myeloma. (Medscape Oncology)
PFE..$21.10 & BMY..$32.29 FDA extends Eliquis PDUFA date for atrial fibrillation/stroke prevention by 3 months. The new PDUFA date is June 28th, 2012. No Advisory Panel meeting has been scheduled.
http://finance.yahoo.com/news/u-food-drug-administration-extends-030100167.html
OT: FDA announces safety changes in labeling for some cholesterol-lowering drugs http://1.usa.gov/xmkEwx
Bayer, J&J clot drug to get fast FDA review for ACS: Reuters Tue, 02/28/12 http://dlvr.it/1FwctL
SLXP $49.32 On 2/28 Auriga ups from Hold to Buy w/ $55 target.
Why No Obesity Drug Will Ever Be The Next Lipitor - Forbes http://onforb.es/x8qMX8 VVUS, ARNA, & OREX
OT: George Sledge on the science of insomnia. (Good article) http://bit.ly/wB5DDt
BIIB..$116.79 FDA approves AVONEX® PEN and dose titration regimen. http://finance.yahoo.com/news/FDA-Approves-AVONEX-PEN-Dose-bw-79320495.html
BDSI..$2.26 and FDA reach agreement on BEMA Buprenorphine/Naloxone (BNX) development plan. http://bit.ly/zGEs7v
OT: Fake Avastin contained salt, strach and chemicals used in animal feed, and no active drug at all, according to Genentech. (Medscape Oncology).
AMRN - what a day for trading this stock. Amarin Reports Fourth Quarter and Year-End 2011 Financial Results and Provides Update on Operations
Conference Call Set for 4:30 p.m. EST Today
GlobeNewswirePress Release: Amarin Corporation plc – 41 minutes ago
RELATED QUOTES
Symbol Price Change
AMRN 7.75 -0.98
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 29, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN - News), a late-stage biopharmaceutical company focused on cardiovascular disease, today announced financial results for the quarter and year ended December 31, 2011 and provided an update on company operations.
Key Amarin accomplishments since the quarter ended September 30, 2011 include:
* Acceptance of AMR101 New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) and FDA assignment of Prescription Drug User Fee Act (PDUFA) date of July 26, 2012
* Strengthened balance sheet through successful completion of a $150M exchangeable note offering
* Commenced patient enrollment and dosing in the REDUCE-IT cardiovascular outcomes study
* Broadened management team with the addition of a General Counsel and a President of R&D
"In 2011, Amarin made important progress toward the development of, and commercial preparedness for, our lead product candidate, AMR101," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "In 2012 we are working vigorously to build on this progress and maximize the value of AMR101 as we advance toward the PDUFA date."
http://finance.yahoo.com/news/amarin-reports-fourth-quarter-end-210100913.html
ALXA,
Somebody wants shares of this stock.
On a down Market day,ALXA closed at .625,up 4.17%.
The stock is now above the downtrend line.
http://finviz.com/quote.ashx?t=alxa&ty=c&ta=1&p=d
Manny
BRIEF-Amarin updates on FDA advisory committee schedule in connection with NDA for AMR101
Feb 13 (Reuters) - Amarin Corp PLC <AMRN.O>:
* Announces FDA advisory committee will not be scheduled in connection with new
drug application for AMR101
* FDA had previously assigned pdufa date of July 26 2012 for completion of its
review of the AMR101 NDA
Follow Me on Twitter: http://twitter.com/SheffStation/
New Economy Portfolio: Larger Cap stocks for slower but more consistent gains. Some Longer-Term Plays (30-60 days maybe longer)
Beginner Portfolio: Scalp Plays & Low Float Biotechs for potential explosive Growth. Quick Turnover 1-30 days (smaller balance want aggressive growth)
Position Size: STARTER: (1-5% Portfolio Balance) SOLID: (6-10% Portfolio Balance) FULL : (11-20% Portfolio Balance)
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$HEFF LEARNING STATION-LINKS
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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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