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News on CVM:
http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#cvm
Co announces the Institutional Review Board of the U.S. Navy's Naval Medical Center San Diego, has approved the start of a Phase I dose escalation study of the Company's investigational immunotherapy Multikine in HIV/HPV co-infected men and women with peri-anal warts. This approval marks the third indication for which Multikine is being investigated in clinical trials. Multikine is currently being investigated in the largest Phase III trial in the world for the treatment of head and neck cancer. It has previously been evaluated as a potential treatment for cervical dysplasia in HIV/HPV co-infected women and a Phase II study to further investigate this indication is currently in the planning stages.
The Phase I dose escalation study is being funded and conducted through a Cooperative Research and Development Agreement between the U.S. Navy and CEL-SCI.
CEL-SCI will contribute the investigational immunotherapy drug Multikine, will retain all rights to any currently owned technology and will have the right to exclusively license any new technology developed from the collaboration.
By entering into this CRADA, NMCSD does not directly or indirectly endorse any product or service provided, or to be provided, by CEL-SCI, its successors, assignees, or licensees.
Thanks. Looks like they put out an update every Monday:
Press Releases for SSN
Samson Oil & Gas Operational Advisory - Business Wire 01.20.14 | 08:01 pm
Samson Oil & Gas Operational Advisory - Business Wire 01.13.14 | 06:01 pm
Samson Oil & Gas Operational Advisory - Business Wire 01.06.14 | 08:01 pm
Samson Oil & Gas Operational Advisory - Business Wire 12.30.13 | 08:12 pm
Samson Oil & Gas Operational Advisory - Business Wire 12.23.13 | 08:12 pm
Will see on Monday.
Hi AF - Do you see an upward movement on this one next week? It bounced back up late in the last hour.
Thanks.
Yes, saw those trades. Will see tomorrow.
Trying to find if HEB has some upcoming catalysts but none so far. You'll see it if I do. I am new to the board and thank you for you hard work.
Better-ranked stocks in the gold mining industry include Golden Star Resources, Ltd. (GSS) and Lake Shore Gold Corp. (LSG). Both hold a Zacks Rank #2 (Buy).
http://www.barchart.com/headlines/story/2751506/barrick-to-sell-kanowna-gold-mine-analyst-blog
Thanks. Trying to follow your great board here, great people!!
Have you heard of Encanto Potash?
Encanto Potash announces positive Ochapowace/Chacachas drill results
http://finance.yahoo.com/news/encanto-potash-announces-positive-ochapowace-134500748.html
Morning AF and thanks for the info.
Anyone here has SSN?
Which U.S. markets are open on Martin Luther King Jr. Day?
January 17, 2014, 3:25 PM
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U.S. investors are heading into a three-day holiday weekend. Martin Luther King Jr. Day on Monday is a federal holiday, which means that the U.S. stock and bond markets, along with government and state offices and post offices, banks and schools, will be closed.
U.S. floor trading sessions will be closed, but a few electronic-trading markets are open:
The CME Group’s CME trading in stock-index futures SPH4 will be open, for a trade date of Tuesday, Jan. 21, at 6 p.m. Eastern on Sunday and will pause at 11:30 a.m. Eastern on Monday. It’ll reopen at 6 p.m. Eastern time Monday.
Metals and energy futures on the CME, including gold GCG4 and crude oil CLG4 , will be open at 6 p.m. Eastern time Sunday and will pause at 1:15 p.m. Eastern on Monday. They’ll then reopen at 6 p.m. Eastern time Monday evening.
Also on the CME, currency and Treasury futures will open for trading at 6 p.m. Eastern on Sunday and pause at 1 p.m Eastern time Monday, then reopen Monday evening at 6 p.m.
The ICE Futures U.S. ICE Dollar Index futures DXH4 will trade from 8 p.m. Sunday, close early at 1 p.m Eastern on Monday, then reopen at 8 p.m. Monday evening.
Brent crude futures UK:LCOH4 on ICE Futures Europe will have regular electronic-trading hours, from 8 p.m. Eastern Sunday to 6 p.m. Eastern Monday, then reopen again as usual at 8 p.m. Eastern Monday.
http://blogs.marketwatch.com/thetell/2014/01/17/which-u-s-markets-are-open-on-martin-luther-king-jr-day/
LSG just hit .64
Thanks NYBob. Glad to be here. Let's have a great 2014 and thereafter.
IHUB is showing you the CAN sp.
T.LSG
http://www.stockhouse.com/companies/quote/t.lsg/lake-shore-gold-corp
vs.
U.S.
http://finance.yahoo.com/q?s=LSG
CEO bought:
P 2013-12-30 2014-01-02 11:25:47 CEL SCI CORP CVM KERSTEN GEERT R CEO 300,000 $0.60 $180,000.00 725,227
I have ARNA and ARIA with avg. around 2.50. Been traveling and finally back home. Trying to follow your lead and this great board - got in LSG and AAU so far. You have a great team here if I may say so.
Small world. Yeah I surf in Del Mar, Torrey Pines, and of course La Jolla. I'm 2 blocks from the Cove.
Thanks you.
Hi AF - Are you in AAU? Broke 1.32. Thanks.
Thank you. Great work!
CHTP - 16 to 1 in favor.
I think people are getting in and wait for the ODS status.
News out for ARIA
http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#aria
7:38 am Ariad Pharm and Medinol announce initiation of two registration trials of the NIRsupreme Ridaforolimus-Eluting Stent for use in coronary artery disease; triggers milestone payments to ARIAD of $3.75 mln (ARIA) :
Co and Medinol announced the initiation of two registration trials of Medinol's NIRsupremeTM Ridaforolimus-Eluting Coronary Stent System incorporating ARIAD's mTOR inhibitor, ridaforolimus. The two NIRsupreme clinical trials are randomized, single-blind, global studies taking place in the United States, Europe, Israel and Canada and will enroll approximately 2,200 patients with coronary artery disease. ARIAD licensed ridaforolimus to Medinol for use in drug-eluting stents in 2005. Drug-eluting stents (DES) are now implanted in over 500,000 patients yearly in the United States.
The commencement of patient enrollment in Medinol's clinical trials, along with the submission of an investigational device exemption with the FDA, triggers milestone payments to ARIAD of $3.75 mln, with the potential for additional regulatory, clinical and sales milestones, as well as royalties on product sales.
ARIAD entered into a non-exclusive agreement with Medinol to develop and commercialize stents and other medical devices to deliver ridaforolimus to prevent reblockage of injured vessels following stent-assisted angioplasty. ARIAD is eligible to receive additional regulatory, clinical and commercial milestones of up to $34.75 mln, if two products are developed, plus royalties on worldwide product sales. ARIAD is responsible for supplying ridaforolimus to Medinol, and Medinol is responsible for the development and commercialization of the medical devices delivering ridaforolimus. These rights are separate from those licensed to Merck for use of ridaforolimus in oncology.
Please see below:
Designating an Orphan Product: Drugs and Biological Products
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.
http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm
Morning AF - IMO, I think DARA will get the ODS soon. I'm thinking about getting in / out by Feb.
According to Jason Napodano. ODS could be this month or early Feb.:
KRN5500 is a potential $250 million drug in CCIPN. The upfront payment alone from a potential interested party could double the shares. Research shows that Orphan Drugs do tend to succeed at higher rates than non-Orphan Drugs, and the FDA has stated a goal to respond to all applications in 75 days. DARA submitted a response to questions from the agency on September 10, 2013. Additional data was provided to the agency in November 2013. We expect a decision in the next month or two, and believe that could be a major catalyst for re-valuation at a higher level.
http://seekingalpha.com/article/1900351-orphan-designation-a-game-changer-for-dara
KRN5500 has mostly been an afterthought in our investment thesis that centers on the company's core commercial assets in Soltamox, Gelclair, and Bionect. However, Orphan Drug status for KRN5500 changes things - it creates enormous upside coming from the pipeline, as well as partnerships. A partnership is something that could come with a sizable upfront payment and development milestone that DARA can use to continue the expansion and stepped-up promotion of the commercial assets. We already rate DARA Bio a 'Buy' with a $1.50 target. Getting Orphan Drug designation for KRN5500 turns this potential triple into a home run. It's a beautify turnaround story in 2014, if it all comes together.
From IV:
Re: DTC/TV/PeopleMag
Well, it turns out you may be more right than you know with your comments. As we know from JD's Friends' post; the Ad Agency has a casting call out for actors/actresses for a Belviq commercial. I spoke with him about 3:30PST about this and he has applied for one of the parts for the commercial. Hopefully, he gets it since he is a good actor and has done very good commercials in the past.
Not sure if this is the first commercial being cast for Belviq or not. It sounds like from my conversation with my good friend that this could be a very creative commercial for Belviq. Anyway, we will have to stay tuned, but I think your thinking is spot on target.
SAN DIEGO, Jan. 6, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) announced today that the company is scheduled to present a corporate overview at the 32nd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2014, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) at The Westin St. Francis Hotel in San Francisco, California.
Thank you very much AF. You all are doing an amazing job here. Simply amazing what you all are doing here.
Hi AF - where do you see LSG in the few days? TIA.
From flogonuzim on YMB:
EMA CHMP MAA Clock stopped at day 180......
Navidea will supply answers to the outstanding issues revealed at day 180 on the CHMP Clock. Once CHMP has Navidea answers to outstanding issues the CHMP Clock starts again. At day 210 of the CHMP Clock, Navidea will be in Section 2.1 of the CHMP Session Agenda and Opinion will be made. Basically, this is EMA CHMP Approval point. Then, it usually take about 67 days to issue the official legally binding EC Decision.
So.....that means once Navidea answers the outstanding issues, the clock will restart and they will be up for CHMP Opinion (Session 2.1 on CHMP Agenda) in 30 days (day 210 on CHMP Clock). Once we get the day 210 CHMP Opinion Approval it will take an additional 67 days on the CHMP Clock to make EC Decision legally binding for distribution.
Earliest possible date for CHMP Opinion is February meeting. Earliest date for CHMP EC Decision would be the April CHMP Session.
Let's consider FDA Approval for Lymphoseek. We received approval in March and revenue is just now kicking in. Navidea has stated previously and in the recent CHMP press release that they expect European revenues to start in 2015. Based on the time it took to get Lymphoseek distributed in the USA after approval, I'm guessing the company is expecting CHMP Session 2.1 Opinion Approval in February to April time frame. This would put CHMP EC Decision in the April to June time frame. That would put revenues out to about the 2015 point to kick in.
It is my opinion, once Navidea gets the CHMP Opinion in the February to April time frame, they will be working concurrently to enable distribution/sale of Lymphoseek as soon as CHMP EC Decision is given.
2014 is going to be a game changing year for Navidea. They have a great pipeline ---
* Lymphoseek - expanding indications in process now
* NAV4694 - Ph3 trial underway. Ph2b Trial underway - Alzheimer's
* NAV5001 - Ph2b underway. Ph3 trial 2013
* Manocept - plethora of possibilities
* RigScan - cannot describe the impact when approved.
It's normal now a day. Many companies are outsourcing their investor relations, human resources, etc.
You didn't talk to him. I saw your tweet yesterday. Please read that article from my previous post.
From the article:
Dara is currently engaged in dialogue with the FDA on ODD. According to management, they are in round three of responding to questions from the agency. The company filed a response to the FDA on August 8, 2013. If timelines hold, a decision from the FDA should be made in October or November 2013.
They who? You? Stop spreading lies. Oct. - Nov.
From Jason N. August 15th:
However, the biggest catalyst on the horizon is the pending ODD decision by the U.S. FDA, expected in October or November 2013. A positive decision on this front has the potential to double the shares, and lead to a partnership for KRN5500 from a larger pharmaceutical company that could bring in significant upfront cash. With this cash, Dara can funnel money back to increasing the market and promotion around Soltamox and Gelclair.
http://seekingalpha.com/article/1638362-patience-required-for-dara-bio-investment
Morning AF!
Do you still own DVAX?
Obesity Death Toll Heavier Than Previously Thought
http://www.weather.com/health/obesity-death-toll-heavier-previously-thought-20130816