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1:23AM DepoMed FDA issues Complete Response Letter on SEFELSA New Drug Application (DEPO) 5.76 : Co announces that the FDA issued a complete response letter to the New Drug Application for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause. The CRL states that the FDA cannot approve the application in its present form. Based on the letter, Depomed does not currently intend to further invest in SEFELSA.
News after hours today. PDUFA.
FDA announcement should be in AH.
Well, what do you think, should be a decent entry for a PDUFA run up?
March 4, 2013
13:57 EDT DEPO Depomed retreats after FDA panel votes against approving drug
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13:54 EDT DEPO Depomed resumes trading, down 9.8% after FDA advisors vote against drug approval
13:38 EDT DEPO Depomed says will cease all spending related to Sefelsa following FDA meeting
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13:37 EDT DEPO Depomed to resume trading at 13:50 ET
Quotes resume at 13:45 ET.
13:33 EDT DEPO Depomed provides update on Sefelsa FDA advisory committee
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12:44 EDT DEPO Depomed's proposed menopause treatment rejected by FDA panel, WSJ says
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11:40 EDT DEPO FDA panel says Depomed menopause drug ineffective, DJ reports
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07:41 EDT DEPO FDA's Reproductive Health Drugs Advisory Committee to hold a meeting
The Committee discusses Depomed's New Drug Application for Serada(r). Serada is Depomed's proprietary extended release formulation of Gabapentin in development for treatment of menopausal hot flashes. The meeting is being held at FDA offices in Silver Spring, Maryland on March 4 at 8 am. Webcast Link
07:01 EDT DEPO Depomed trading halted, news pending
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Here comes the pain!!!
Took DEPO off the table....
8:00AM DepoMed announces Serada NDA acceptance and FDA Advisory Committee Meeting (DEPO) 6.05 : Co announced that its New Drug Application (NDA) for Serada has been accepted for filing by the U.S. Food and Drug Administration (FDA). In addition, the FDA has informed the company that the FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at an Advisory Committee meeting tentatively scheduled for March 4, 2013. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
8:02AM DepoMed reports that BREEZE 3 data for Serada was presented that showed that may help manage menopausal hot flashes (DEPO) 6.14 : The results of the supportive ANCOVA parametric analysis of the BREEZE 3 data were presented at NAMS. In this analysis, Serada significantly reduced the frequency and severity of hot flashes at 4 weeks and 12 weeks compared with placebo. These reductions were maintained out to 24 weeks. In addition, an assessment of sleep measures taken at the start of the trial indicated that, on average, women had clinically meaningful improvements in insomnia and sleep disturbance.
8:04AM DepoMed announces publication of Phase 3 data from Gralise Clinical Trial; says 'This difference from placebo was statistically significant' (DEPO) 5.59 : Co announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN). The results showed that patients treated with Gralise experienced a significant reduction (- 2.12) in their average daily pain intensity compared with placebo treated patients (-1.63; P=0.013). This difference from placebo was statistically significant after one week and continued to be superior through the duration of the study.
8:28AM On The Wires (WIRES) : Depomed (DEPO) has received a notice of allowance from the USPTO for a patent application further expanding the patent portfolio around Gralise (gabapentin), the co's once-daily product for the management of postherpetic neuralgia. The allowed patent claims include claims related to gabapentin matrix dosage forms that release gabapentin to the upper gastrointestinal tract over five to 12 hours and are characterized by specific pharmacokinetic parameters.
4:17PM DepoMed beats by $0.08, beats on revs (DEPO) 5.71 +0.02 : Reports Q1 (Mar) loss of $0.16 per share, $0.08 better than the Capital IQ Consensus Estimate of ($0.24); revenues fell 79.8% year/year to $16.8 mln vs the $12.74 mln consensus. Note first quarter 2011 revenues included recognition of a $48 million milestone payment and recognition of $12.6 million in license revenue from Abbott and $15.3 million of Glumetza sales which explains the 79% decrease in revenue.
I can't answer you on Sheff's board. I let my subscription run out and i guess you have to pay to be on his board.
I will sign up again today
CYTR Thanks for the info. I just doubled up yesterday!!
6:31AM DepoMed files patent infringement lawsuit against Gralise ANDA filers (DEPO) 6.16 : Co announced it has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against three companies that have filed Abbreviated New Drug Applications with the FDA to market generic Gralise (gabapentin), Depomed's once-daily gabapentin product for the management of postherpetic neuralgia. The lawsuit claims infringement of Depomed's six US patents listed for Gralise in the FDA's Orange Book, the last of which expires in 2024, by each defendant's proposed generic product. Depomed has received a Paragraph IV certification notice from each defendant alleging that Depomed's patents will not be infringed by the proposed generic product, or the patents are invalid or unenforceable. The defendants in the lawsuit are: Actavis Elizabeth LLC and an affiliated company; Watson Laboratories Inc. - Florida and affiliated companies; and Incepta Pharmaceuticals Co. Ltd. Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the Gralise ANDAs for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
~ Monday! $DEPO ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $DEPO ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=DEPO&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=DEPO&p=W&b=3&g=0&id=p54550695994
~ Google Finance: http://www.google.com/finance?q=DEPO
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=DEPO#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=DEPO+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=DEPO
Finviz: http://finviz.com/quote.ashx?t=DEPO
~ BusyStock: http://busystock.com/i.php?s=DEPO&v=2
<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=DEPO >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
12. DepoMed Inc. (DEPO): Develops and commercializes pharmaceutical products based on its proprietary oral drug delivery technologies in the United States. Market cap of $341.26M. PEG at 0.13, P/FCF at 4.70. Net insider shares purchased over the last six months at 25.0K, which is 0.05% of the company's 46.32M share float. The stock is a short squeeze candidate, with a short float at 8.3% (equivalent to 8.49 days of average volume). The stock has had a good month, gaining 31.34%.
*Insider data sourced from Yahoo! Finance, all other data sourced from Finviz.
http://seekingalpha.com/article/321862-12-highly-undervalued-stocks-being-snapped-up-by-insiders?source=yahoo
Depomed Announces Initiation of Phase 2 Clinical Study in Parkinson's Disease
GlobeNewswirePress Release: Depomed, Inc. – 2
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MENLO PARK, Calif., Jan. 24, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO - News) today announced that it has initiated a Phase 2 clinical trial of DM-1992, Depomed's novel gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations.
"We believe DM-1992 may meet a significant unmet need of Parkinson's patients. DM-1992 is intended to be dosed twice-daily and to maintain consistent therapeutic blood levels of carbidopa/levodopa throughout the full 24 hour period and reduce the off/on fluctuations which occur with existing levodopa therapies and are so troublesome to Parkinson's disease patients," said Michael Sweeney, MD, Depomed's Chief Medical Officer and Vice President, Research and Development.
"Carbidopa/levodopa (CD/LD) is still considered the gold standard for treatment of Parkinson's disease," said Leo Verhagen, MD, PhD, a Parkinson's disease expert at Rush University Medical Center in Chicago, "but as the years go by, the duration of the benefit from each dose of CD/LD becomes progressively shorter. As a result, patients will take this medication many times (in some cases up to 10 times) per day. Even then they will still experience acute fluctuations between short periods of good mobility ("on" time) and episodes of immobility ("off" time). Therefore, having a CD/LD product that could provide more consistent blood levels for a longer period of time would represent an exciting addition to our current treatment options."
Phase 2 Trial Design
DM-1992 is an investigative novel gastric-retentive, extended-release dosage form of carbidopa/levodopa, a marketed therapy used in the treatment of Parkinson's disease. The Phase 2 clinical trial is designed to enroll at 8 U.S. clinical centers up to 45 patients with Parkinson's disease with motor fluctuations. The trial is a randomized, active-controlled, open-label, crossover study and will test DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed. The study will assess efficacy, safety and pharmacokinetic variables. The primary endpoint for the study is change in off time as measured by patient self-assessment and clinician assessment.
Depomed does have products besides Serada. This from a July 2001 PR:
Bad news re the Phase III trials for the extended-release gabapentin tablets failed to achieve one of four primary goals and "key" secondary endpoints of the study, the company said. And the drug's effects appeared to taper off about halfway through the 24-week study period. The trial fell short of meeting the primary endpoint of improving frequency of hot flashes at 12 weeks and the secondary endpoints of frequency and severity at 24 weeks, according to the company.
Read more: Depomed shares crater on another Phase III miss for hot-flash drug - FierceBiotech http://www.fiercebiotech.com/story/depomed-shares-crater-another-phase-iii-miss-hot-flash-drug/2011-10-14?utm_medium=rss&utm_source=rss#ixzz1alPU6CX2
Question: Are there any healthcare stocks worth buying right now?
Answer: I’m starting to buy back a position in DepoMed, Inc. (NASDAQ:DEPO). Pending 4th Quarter clinical trial results, DepoMed could offer the first FDA-approved drug to treat symptoms of menopause. I’ve traded the stock profitably over the past few years. The August correction has given me an opportunity to buy it back at a lower price than I sold it a couple of months ago.
http://www.forbes.com/sites/kenkam/2011/09/02/the-top-healthcare-investor-is-selling-healthcare/?partner=yahootix
4 Biotech Stocks With Strong Cash Flow Growth Over the Last 5 Years
4. DepoMed Inc. (DEPO): Drug Manufacturers Industry. Market cap of $469.08M. TTM Operating cash flow/common equity at 1.26 vs. 3-year average at 0.52 and 5-year average at -0.20. The stock is a short squeeze candidate, with a short float at 11.89% (equivalent to 7.43 days of average volume). The stock has had a couple of great days, gaining 6.85% over the last week.
*Operating cash flow/common equity sourced from Screener.co, all other data sourced from Finviz.
http://seekingalpha.com/article/278996-4-biotech-stocks-with-strong-cash-flow-growth-over-the-last-5-years?source=yahoo
5 Highly Profitable Stocks Undervalued by EPS Trends
5. DepoMed Inc. (DEPO): Drug Manufacturers Industry. Market cap of $463.17M. TTM net profit margin at 71.74% vs. 5-year average at -9.60%. Over the last 30 days, analyst projected EPS has increased 1.85% (from $1.62 to $1.65), while the price has increased 0.83% (from $8.46 to $8.53). The stock is a short squeeze candidate, with a short float at 11.89% (equivalent to 7.52 days of average volume). The stock has had a couple of great days, gaining 6.02% over the last week.
*Net profit margin data sourced from Screener.co, EPS and price data sourced from Yahoo! Finance, all other data sourced from Finviz.
http://seekingalpha.com/article/278773-5-highly-profitable-stocks-undervalued-by-eps-trends?source=yahoo
4 Stocks With High Cash-Flow Growth and Strong Sources of Profitability
2. DepoMed Inc. (DEPO): Drug Manufacturers Industry. Market cap of $450.29M. MRQ Net Profit Margin at 118.92% vs. one-year-ago quarterly Net Profit Margin at -24.93%. MRQ Sales/Assets at 0.46 vs. one-year-ago quarterly Sales/Assets at 0.18. MRQ Assets/Equity at 1.45 vs. one-year-ago quarterly Assets/Equity 6.6. TTM Operating Cash Flow/Common Equity at 1.26 vs. five-year average at -0.20. The stock is a short squeeze candidate, with a short float at 11.89% (equivalent to 7.54 days of average volume). The stock has gained 31.92% over the last year.
http://seekingalpha.com/article/278201-4-stocks-with-high-cash-flow-growth-and-strong-sources-of-profitability?source=yahoo
Depomed Appoints James A. Schoeneck President and CEO
Date(s): 4-Apr-2011 7:00 AM
For a complete listing of our news releases, please click here
Menlo Park, Calif., April 4, 2011 - Depomed, Inc. (NASDAQ: DEPO) today announced the appointment of James A. Schoeneck as the company's President and CEO, effective April 18, 2011. Mr. Schoeneck, a member of the company's Board of Directors since 2007, succeeds Carl A. Pelzel, who has resigned for personal reasons.
Peter D. Staple, Chairman of Depomed's Board of Directors, said, "We are delighted that Jim has agreed to lead Depomed as the company accelerates its transition as a commercial enterprise. He has a great track record of commercial and operational achievements and developing successful business strategies. This experience will be invaluable as we leverage Depomed's considerable assets to the benefit of the company and its shareholders. During Jim's three years of Board service, he has been closely involved in overseeing our business strategy and operations. He is well positioned to assume leadership of the company." Mr. Staple added, "On behalf of the entire Board, I also want to thank Carl for his committed service and leadership that helped to transform Depomed from a development organization to a company with strong assets, momentum, and attractive growth prospects."
Mr. Schoeneck said, "I am excited to join Depomed and to work more closely with Depomed's accomplished leadership team and employees. The recent approval of GraliseTM (gabapentin) provides us with a tremendous opportunity to generate revenue growth through a direct commercial presence. Depomed is poised to build significant near-term value for all those we serve - investors, patients, physicians and payors." Mr. Schoeneck commented, "The company has approved products, a promising late-stage product candidate in Serada®, revenue from technology licenses, and over $160 million in cash."
Since 2005, Mr. Schoeneck, 53, has served as chief executive officer of BrainCells Inc., a private biopharmaceutical company in San Diego, California. Mr. Schoeneck's broad pharmaceutical experience includes three years as the president and chief executive officer of Prometheus Laboratories Inc., a specialty pharmaceutical company. At Prometheus, Mr. Schoeneck led the company to profitability and rapid revenue growth, increasing sales from $6 million to over $70 million. Under Mr. Schoeneck's leadership, Prometheus was recognized as the third fastest growing private company in America by Inc. magazine.
Prior to Prometheus, Mr. Schoeneck spent three years at Centocor, Inc., where he led the development of Centocor's commercial capabilities, growing his team from three people to almost 500 in less than three years. His group launched Remicade®, which has become the world's fifth largest selling pharmaceutical product, with over $7 billion in sales in 2010.
Earlier in his career, he spent 13 years at Rhone-Poulenc Rorer, Inc. (now Sanofi-Aventis) serving in various sales and marketing positions of increasing responsibility, including the launch of products that generated over $300 million in annual sales. Prior to joining BrainCells, he was chief executive officer of ActivX BioSciences, a development stage biotechnology company.
Conference Call
Depomed will host a conference call on Monday, April 4, 2011 at 8:00 AM EDT to further discuss the matters disclosed above.
The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and another recently approved product. GraliseTM (gabapentin) is a once-daily treatment approved for the management of post-herpetic neuralgia (PHN). Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. The company also has a robust pipeline including Serada®, which is in Phase 3 clinical development for menopausal hot flashes, as well as earlier stage candidates. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
Forward-looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements, including statements related to the Company's business prospects under new leadership, should not be regarded as a representation by Depomed that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Depomed's business, including, without limitation: risks related to the launch of GraliseTM; and other risks detailed in Depomed's prior press releases and public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Depomed does not undertake any obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT:
Sheilah Serradell
Depomed, Inc.
(650) 462-5900
sserradell@depomed.com
Depomed has added a news release to its Investor Relations website.
Title: Depomed Reports Fourth Quarter and Year-End 2010 Financial Results
Date(s): 3-Mar-2011 4:05 PM
For a complete listing of our news releases, please click here
MENLO PARK, Calif., Mar 3, 2011 (GlobeNewswire via COMTEX) --
Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the fourth quarter and year ended December 31, 2010.
"We are pleased to report a profitable year and our third consecutive profitable quarter," said Carl A. Pelzel, president and chief executive officer of Depomed. "Our excellent financial performance and business progress in 2010, as well as the $48 million milestone payment from Abbott Products received last week, provide us with substantial resources to pursue our plan to achieve sustainable profitability from recurring operating revenue from our own specialty pharmaceutical business. Meanwhile, we look forward to the results of Serada's Breeze 3 trial later this year, as enrollment has just concluded," Mr. Pelzel added.
Fourth Quarter 2010 and Recent Highlights
-- Presentations of Breeze 1 and 2 clinical data at the North American
Menopause Society annual meeting (October 2010);
-- Awarded a second grant by The Michael J. Fox Foundation to support
clinical development of DM-1992 for Parkinson's disease (October 2010);
-- Receipt of a $5.0 million milestone payment from Janssen Pharmaceutica
for delivery of formulation (October 2010, recognized as revenue during
the third quarter of 2010);
-- Receipt of a $2.5 million development milestone payment pursuant to the
agreement with Merck (October 2010, recognized as revenue during the
fourth quarter of 2010);
-- Availability and re-launch of Glumetza 500mg tablets (January 2011);
-- Achievement of a $3.0 million Glumetza sales milestone payment from
Santarus, Inc. to be paid in March 2011 (January 2011);
-- US FDA approval of Gralise (gabapentin) once-daily tablets for treatment
of post-herpetic neuralgia (January 2011);
-- Results of the Phase 1 trial of twice-daily formulation of DM-1992 in
Parkinson's patients (February 2011);
-- Receipt of a $48.0 million milestone payment from Abbott Products on FDA
approval of Gralise (February 2011);
-- Completion of enrollment in Breeze 3, our pivotal Phase 3 trial
evaluating Serada for menopausal hot flashes (March 2011).
Depomed Fourth Quarter and Full-Year 2010 Financial Highlights
Total revenue for the fourth quarter of 2010 was $20.9 million compared to $13.2 million in the fourth quarter of 2009. The increase in revenue in the fourth quarter of 2010 was the result of recognition of the $2.5 million Merck milestone, an increase in Glumetza product sales and revenues related to our collaborative arrangements with Janssen and Covidien.
Total revenue for the year-ended December 31, 2010 was $80.8 million compared to $57.7 million for the year-ended December 31, 2009. The increase in revenue in 2010 was the result of increases in Glumetza product sales and revenues related to our collaborative arrangements with Abbott Products, Janssen and Covidien.
Glumetza product sales were $11.5 million and $45.5 million for the fourth quarter and year-ended December 31, 2010, as compared to $9.8 million and $34.6 million for the corresponding periods in 2009.
Operating expenses were $18.5 million for the fourth quarter of 2010 and included $7.7 million in promotion fee expense related to the Company's promotion agreement with Santarus, compared with operating expenses of $15.3 million for the fourth quarter of 2009, which included $6.6 million in promotion fee expense.
Operating expenses were $69.0 million for year ended December 31, 2010 and included $31.4 million in promotion fee expense, compared with operating expenses of $74.5 million for the year ended December 31, 2009, which included $23.6 million in promotion fee expense. The decrease in operating expenses for the year ended December 31, 2010 was primarily driven by the completion of the Phase 3 clinical trial for Gralise and completion of the first two Phase 3 clinical trials for Serada during 2009.
Net income during the fourth quarter of 2010 was $1.7 million, or $0.03 cents per share, compared to a net loss during the fourth quarter of 2009 of $3.6 million, or $0.07 cents per share.
Net income for the year ended December 31, 2010 was $3.9 million, or $0.07 cents per share, compared to a net loss during the year ended December 31, 2009 of $22.0 million, or $0.43 cents per share.
Cash, cash equivalents and marketable securities were $76.9 million as of December 31, 2010 compared to $81.8 million as of December 31, 2009. Cash, cash equivalents and marketable securities at December 31, 2010 does not include the $48.0 million milestone payment from Abbott Products that we received in February 2011.
Conference Call
Depomed will host a conference call today, Thursday, March 3, beginning at 5:00 p.m. ET, 2:00 p.m. PT to discuss its results. The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. Gralise(TM) (gabapentin) is a once-daily treatment approved in the United States for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products, Inc. Glumetza(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada(R) is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
$DEPO Completes Enrollment of Breeze 3 Phase 3 Clinical Trial http://yhoo.it/ikpQPr
of 40870
DEPO
Depomed has added a news release to its Investor Relations website.
Title: Depomed Announces Receipt of a $48 million Milestone Payment for the Approval of GRALISE(TM)
Date(s): 28-Feb-2011 8:00 AM
For a complete listing of our news releases, please click here
Menlo Park, Calif., February 28, 2011 - Depomed, Inc. (NASDAQ: DEPO) today announced that it has received a $48 million milestone payment from Abbott Products, Inc., for the U.S. Food and Drug Administration's approval of GRALISE(TM) (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles.
OT: Yes, it appears AIS will be waiting till April for the NDA ...
DEPO.....Intereresting developments!
Tim
Good comeback for a Friday and a screwed up world.
Both Depo and AIS looking good going into the weekend.
If all goes well next week could be a fun time.
GLTA & have a great weekend.
add2it
AIS and BPAX
Investors will look closely at data from Libigel update presentation
Posted on 02/11/11 at 10:00am by Comtex News
(via COMTEX News Network)--
This weekend, biotech investors and the rest of the medical community will get an update on the largest-ever safety study comparing low-dose testosterone treatments to placebo treatment for menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).
Two companies in prime position to benefit from good news associated with this weekend's updated clinical information are BioSante Pharmaceuticals (Nasdaq: BPAX) and their partner, Antares Pharma, Inc. (AMEX: AIS).
Both companies have a large stake in LibiGel- a testosterone gel that is the focus of that Phase III clinical trial and is now clearly the lead product in development for treating female sexual dysfunction. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement.
Read more: http://www.benzinga.com/press-releases/11/02/c853794/investors-will-look-closely-at-data-from-libigel-update-presentation#ixzz1DfmUo53V
http://www.benzinga.com/press-releases/11/02/c853794/investors-will-look-closely-at-data-from-libigel-update-presentation#ixzz1DfgRIoa4
Congrat!!
Smart move going to AIS!!
Big things coming 2/22/11!!
Anyhow!!!
I love your strategy!!
Definate agree with your synopsis u laid out!
Gltu
Tim
I don’t see us dropping back to the $6s.
I think the only reason we dropped to this level is a lot of holders don’t want to hold on for the “eight weeks”? before the decision and I think today’s LOD of $8.88 may be the low until we hear anything about Abbott or a new deal. Either way I feel DEPO is in the driver’s seat and we will profit from another rise after the news.
I would be happy with anything around $10.50 – $11.00.
I did sell a portion of my DEPO shares @ $9.90 to buy into AIS @ $1.66, looking for their news on the 22nd.
I definitely feel we have more coming with DEPO if I can let it ride long enough but if it gets to around $10 again and I need the powder I would cash out.
This is all IMHO.
GLTA
Long DEPO
add2it
Keeping this on watch and seeing if we back fill down to the low 6's?
Your thoughts?
Tim
Waiting to hear ABT news etc..
Another "solid brick for DEPO!"
Tim
All Good for later this year...
News Breaks
08:16 EDT DEPO theflyonthewall.com: DepoMed reports results of Phase 1 Parkinson's study for DM-1992
Depomed announced that in its second Phase 1 pharmacokinetic-pharmacodynamic study in Parkinson's patients, DM-1992, Depomed's investigative novel gastric-retentive, extended-release formulation of levodopa/carbidopa, maintained therapeutic blood levels of levodopa over 24 hours in a twice-daily formulation. Two distinct twice-daily formulations of DM-1992 were tested in the study. Both formulations are projected at steady state to consistently maintain levodopa blood levels above the efficacious threshold of 300ng/mL for 24 hours, as mean levodopa blood levels after 24 hours exceeded 300ng/mL. DM-1992 was well tolerated in the study. The company expects to present the trial results at a scientific conference later this year. :theflyonthewall.com
GLTA
add2it
Blackrock!!!
13-G
Yea!!
Tim
Here we gooooo!!!
$10.25-40
Could be a good Friday?
GLTA
add2it
Ok..Sounds like a plan!!
Go DEPO!!!
Tim
Technically then we're a preteen...
fAt
It's the first step.. $10, $11, $12, $13 etc!
That's how!
Tim
DEPO
How is 10 a teenager?
fAt
Sojieboy:
Yes, DEPO became a teenager, hopefully you covered your short!
Tim
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