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We hit $6.00 with much less.I say higher.
Today the Hammer Candle stick happened. = http://www.trending123.com/patterns/Hammer-Short-term-Pattern.html
Good job eicoman your D.D is just fine.I would take your already proven info over most here. = FACT'S
Shazam619 posted the info first I believe. Will be done in 4 to 8 weeks.Final data Dec 2015. U.S. FDA Resources
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures: •The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. [ Time Frame: 4 - 8weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures: •Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction. [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
This help? It is under the tab named Tabular view.
Recruitment Information
Recruitment Status ICMJE
Enrolling by invitation
Estimated Enrollment ICMJE
100
Estimated Completion Date
December 2015
Estimated Primary Completion Date
December 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:
•18y rs old and above
•Has mild-to-moderate erectile dysfunction
•Currently or previous treated for erectile dysfunction using PDE5 inhibitors, vacuum erection devices (VED), intra-cavernosal injections (ICI) and medical urethral system for erection (MUSE).
•Sexually active
•Has a regular sexual partner
Exclusion Criteria:
•Known allergy to alprostadil
•Unable to provide own informed consent
•Unable to understand and complete a questionnaire in English
•Unable to return for a post-treatment clinic evaluation
•Regular sexual partner is unable to understand and complete a questionnaire in English
•Sexual partner is a pregnant or lactating female
Gender
Male
Ages
18 Years and older
Accepts Healthy Volunteers
No
Contacts ICMJE
Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE
Canada
Just started as far as last time I looked.
What it is. Clinical trial
From Wikipedia, the free encyclopedia
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Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. Previously, many emerging countries did not require local trials for product approvals. Now, though emerging countries still accept data from U.S./Europe, they also require some local trials.
Depending on the type of product and the stage of its development, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct larger scale studies in patients that often compare the new product with others already approved for the affliction of interest. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size, and can involve a single research entity in one country or many such entities in multiple countries.
A full series of trials may incur sizable costs, and the burden of paying for all the necessary people and services is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the diversity of required support roles exceeds the resources of the sponsor, a clinical trial is managed by an outsourced partner, such as a contract research organization or a clinical trials unit in the academic sector.
Yes' it looks updated.Nice checking.
Look at chart indicators lower left MACD. http://www.stockta.com/cgi-bin/analysis.pl?symb=APRI&cobrand=&mode=stock
Check it out http://finance.yahoo.com/news/swissmedic-negative-apricus-vitaros-210003425.html 21 minutes ago.
Good refresher on volume. http://www.swing-trade-stocks.com/stock-chart-volume.html
MAYBE THEY ARE MAD AND JUST WANT THE NEW ROOM TEMPERATURE?
I am a buyer tomorrow my friends.Such a freak call to $2.00 and now this. I can wait.PATIENCE WILL BE REWARDED.I buy on the fear and am rewarded for the call more than not. Under two dollars I cannot pass up.
Whatever most of us are in the same boat.Whining doesn't help that's my point.
= lOSERS ARE PEOPLE WHO GIVE UP! I will gladly buy your shares.Good luck!
Up 6 cents pre market on 1000 share trade. http://www.nasdaq.com/symbol/apri/premarket
Hi Courtfool. LOL!
Whats happening just doesnt make sense according to this chart ? Is it just me? http://www.shortanalytics.com/getshortchart.php?tsymbol=APRI
I know its a huge shot in the dark but I sent an email through Chen Lins website and posted the Cantor hold article.I asked him to come out with a followup article on APRI! I said I believe in his points on Apri over Cantor. And at the least I asked him to email me any advice he could on Apri.I said I cannot afford his subscription being a Veteran on Social security disability.Response says within Two days. YOU NEVER KNOW! LOL!
Recent CandleStick Analysis
Very Bullish
Date Candle
Aug-23-2013 Bullish Engulfing
Aug-22-2013 DOJI
Read more at http://www.stockta.com/cgi-bin/analysis.pl?symb=APRI&cobrand=&mode=stock#tOawSkzDsvP38say.99
Recap for new people =
SAN DIEGO, Aug 12, 2013 (GLOBE NEWSWIRE via COMTEX) -- Vitaros(R) National Phase Approvals Granted in the United Kingdom and Sweden
Company to Host Conference Call/Webcast Today at 9:00 AM ET
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") /quotes/zigman/121090/quotes/nls/apri APRI -1.79% (www.apricusbio.com), today provided a corporate update.
"Since the beginning of this year, we have continued to focus our efforts on creating long-term value through our lead product Vitaros(R) and our lead product candidate Femprox(R)," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "The recent approval of Vitaros(R) in Europe marked a significant milestone for Apricus and for our commercial partners Takeda, Sandoz, and Bracco. Moreover, we recently obtained national phase approvals in the United Kingdom and Sweden, and we look forward to additional national phase approvals, continued launch preparations, and the completion of our licensing activities for Vitaros(R) later this year."
Mr. Pascoe added: "For Femprox(R), our novel female sexual dysfunction treatment, we look forward to an End-of-Phase 2 meeting with the FDA in late August, which we expect will provide us with additional clarity regarding the regulatory path forward for this high-potential program. Both Vitaros(R) and Femprox(R) are key value drivers for our shareholders, and as such we are focused on flawless execution of the key initiatives that will lead to successive Vitaros(R) product launches and the development of a successful Femprox(R) clinical program."
Recent Highlights
-- European Approval Decision for Vitaros(R). In June 2013, Apricus Bio announced that its marketing application for Vitaros(R), indicated for the treatment of patients with erectile dysfunction ("ED"), was approved through the European Decentralized Procedure ("DCP"). Under the DCP, the Company filed its application for marketing approval designating Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The CMS includes France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and Luxembourg.
-- National Phase Approvals Granted in the UK and Sweden. Last week, Apricus Bio was granted national phase approvals for Vitaros(R) in the UK and Sweden. The Company continues to work independently as well as with its commercialization partners to obtain the country-by-country national phase approvals for the remaining CMS regions. Our regulatory efforts along with the actions taken by our existing European partners continue to move successfully toward making Vitaros(R) ready to launch in each of the included territories across Europe.
-- Vitaros(R) Partnering Process on Track. Concurrent with the EU approval of Vitaros(R)in June 2013, Apricus Biolaunched a comprehensive partnering process with the goal of licensing Vitaros(R) in the remaining un-partnered territories in Europe, Latin America, and North Africa. Our key partnering objectives for Vitaros(R) are to maximize the total deal value for the asset, expand existing Vitaros partnerships wherever possible, and select partners who have a strong clinical, regulatory and commercial presence in their respective territory. We are reviewing bids recently received from multiple interested parties for the available territories and we expect to complete our Vitaros(R) partnering process in the fourth quarter of this year.
-- Femprox(R) Development Program. Femprox(R) is Apricus Bio's lead product candidate for the treatment of female sexual interest/arousal disorder, or FSIAD. An End-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") is currently scheduled for late August 2013. Following receipt of official FDA meeting minutes, Apricus Bio will be able to provide further clarity regarding the Femprox(R) regulatory pathway in the U.S. To date, the Company has completed seven clinical studies with Femprox(R) including a 100 patient Phase 2 study in the U.S. and a 400 patient proof of concept study in China. The data generated from these clinical studies strongly suggest that Femprox(R) has the potential to effectively treat a patient population where there are currently no available FDA approved treatment options.
-- Completed $17.1 Million Public Offering. In May 2013, Apricus Bio completed an underwritten public offering of its common stock and warrants for gross proceeds totaling approximately $17.1 million, the net proceeds of which the Company intends to use for general corporate purposes, including various development and approval efforts related to Vitaros(R) and Femprox(R).
-- Two Vitaros(R) Poster Presentations at Scientific Meetings. In May 2013, John P. Mulhall, MD, Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center, presented results from an analysis of existing Phase 3 data for Vitaros(R) at the American Urological Association Annual Meeting. The results demonstrated that Vitaros(R) was well tolerated and improved erections in men who were previously unresponsive to PDE-5 inhibitors. In June 2013, the Company presented results from an additional analysis of existing Phase 3 data at the International Symposium on Prostate, Androgens and Men's Sexual Health, which demonstrated increased efficacy and decreased adverse events with longer-term use of Vitaros(R).
Financial Status
Cash and cash equivalents totaled $24.8 million as of June 30, 2013, compared to $15.1 million as of December 31, 2012. Based upon Apricus Bio's current business plan, the Company believes it has sufficient cash reserves to fund its ongoing operations into late 2014. The Company expects to release its second quarter 2013 financial results later this week.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus Bio Conference Call. The conference call will also be webcast live at http://www.investorcalendar.com/IC/CEPage.asp?ID=171412. The teleconference replay will be available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay Passcode 418593 is required for playback. The webcast replay will be available for three months.
About Vitaros
Vitaros has been approved for the treatment of Erectile Dysfunction ("ED") by the European Health Authorities and by Health Canada. Vitaros is a topically-applied cream formulation of alprostadil, a vasodilator, combined with our proprietary permeation enhancer DDAIP.HCL, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE-5 inhibitors for difficult to treat patients, and Vitaros, which was determined to be safe and effective by the European Health Authorities and previously by Health Canada, offers greater market opportunity due to its patient-friendly form versus other alprostadil dosage forms and also relative to oral ED products. With nearly 150 million men worldwide who suffer from erectile dysfunction and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros represents a major market opportunity for Apricus Bio and its commercial partners given its unique product profile and its potential to treat a large underserved population.
About Femprox(R)
Femprox is a product candidate for the treatment of female sexual interest/arousal disorder (FSIAD). Seven clinical studies have been successfully completed to date, including one, 98-subject Phase 2 study in the US and a nearly 400-subject proof of concept study in China. To date, no product has been approved in the U.S. to treat FSIAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. The Company has one approved product, Vitaros, for the treatment of erectile dysfunction, which is now approved in Europe and Canada and will be commercialized by Apricus Bio's marketing partners, which include Abbott Canada, Takeda Pharmaceuticals International GmbH, Sandoz, and Bracco SpA. Femprox, the Company's product candidate for the treatment of female sexual arousal disorder, has successfully completed a nearly 400-subject proof-of-concept study.
For further information on Apricus Bio, visit http://www.apricusbio.com.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop its product Vitaros for erectile dysfunction , and product candidate Femprox for Female Sexual Arousal Disorder among others; to have its product and product candidates receive additional patent protection and be approved by relevant regulatory authorities in Europe, the United States and Canada and in other countries; to successfully commercialize such product and product candidates and other NexACT product candidates and drug delivery technology; to sell its oncology supportive care business or assets to a third party or parties; to cease funding to its French subsidiaries and to have such subsidiaries reorganize or liquidate successfully; and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company
Nice Mr. D.
Thanks eicoman.Just a matter of time.
I prefer charts and numbers over the paid analyst anyday.Look the shorts are dropping big time.http://www.shortanalytics.com/getshortchart.php?tsymbol=apri
This says UK launch plans.Available only to registered users?http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5469
Doesn't bother me a bit binchey those change day to day.I could find good and bad reviews or targets for APRI.Doesn't mean squat to me.My daily d.d far exceeds theirs I am sure.
Possibly Germany launch first, according to below? Only one with dose of 100 and 200 that I can see.
Pretty cool! First of seven pages-http://www.drugs.com/uk/pdf/leaflet/187452.pdf
Sorry RVL just checked in.Thank you eicoman for the repost.
Nasdaq 49 MINUTES OR SO IT HAS BEEN DOWN.http://www.cnbc.com/id/100968086#_gus
No worrys Biggie. I am not worried myself and know it APRI will be much higher in the future.I am considering selling some of my IRE to add more APRI.I was down big when they did a reverse split a couple years ago.I bought in after that to average down my cost per share and am now reaping the rewards.If you do your D.D and believe in yourself and the stock, most times in my experience time will prove you right. GOOD LUCK.
ATLANTA -- Symptoms of female sexual arousal disorder (FSAD) improved significantly during treatment with a topical prostaglandin compared with placebo, results of a randomized clinical trial showed.
Women who used alprostadil (Femprox) cream had as much as 63% improvement in the primary outcome of satisfactory sexual encounters, as defined by responses to a validated sexuality questionnaire.
Younger women (<45) treated with the highest concentration of the medication had the greatest improvement compared with the placebo group.
Women who used the highest concentration of alprostadil cream had significant improvement in all primary and secondary endpoints compared with placebo, as reported here at the American Urological Association meeting.
"I think these results are exciting," Irwin Goldstein, MD, of San Diego Sexual Medicine in California, told MedPage Today. "Women have sexual problems, and we really haven't been addressing them. We haven't been giving them choices, like men have choices, and women need choices just like men do."
Topical alprostadil was generally well tolerated, and adverse events were consistent with drug's known effects, he added.
Some women may find certain nonprescription products helpful with minor problems related to sexual arousal. However, more severe forms of FSAD have proven unresponsive to multiple therapies, including phosphodiesterase type 5 inhibitors and, most recently, topical testosterone preparations.
Alprostadil (Muse) has demonstrated efficacy in the treatment of erectile dysfunction in men. An injectable formulation is approved in the U.S. and a topical formulation has approval in Canada. The topical formulation's vehicle contains a proprietary skin-penetration enhancer that temporarily relaxes tight skin junctions to enable alprostadil delivery and penetration.
Effective tissue penetration by alprostadil results in vasodilation, smooth muscle relaxation, and increased blood flow. Men apply the cream to the head of the penis, whereas the higher dose developed for women is applied to the clitoris and distal anterior vaginal wall, considered the G spot.
"Everyone understands that when you have desire it leads to sexual activity, which is followed by blood flow to the genital tissue, causing an arousal and engorgement response," Goldstein said. "If a woman has issues with arousal, it's problematic. We understand that. That's what erectile dysfunction is in men. There's absolutely no reason not to think that there is a subgroup of women who are unhappy with their sex lives and who could improve their sex lives if they had an appropriate topical agent that's a little stronger than what is currently available."
Goldstein reported updated findings from a phase III, randomized, placebo-controlled clinical trial involving 387 Chinese women with FSAD (J Sex Med 2008; 5: 1923-1931). The study population included pre- and postmenopausal women with a mean age of 45.
The patients were randomized to placebo or one of three concentrations of alprostadil cream: 500, 700, or 900 µg. Each patient received 10 doses of randomized therapy, which was applied prior to sexual intercourse. Follow-up assessments occurred after three to five doses of therapy had been used.
The primary endpoint was defined as the proportion of women in each treatment group who answered "Yes" to Question 3 of the Female Sexual Encounter Profile: "Were you satisfied with your sexual arousal (excitement) during this sexual encounter?"
Secondary endpoints included scores on the Female Sexual Function Index (FSFI), Global Assessment Questionnaire, and the Female Sexual Distress Scale.
Overall, 33% of women allocated to placebo had improvement in satisfactory sexual encounters, compared with 46.3%, 43.5%, and 53.9% of women in the alprostadil groups (P=0.0400 to P=0.0002).
The study population consisted of 168 women ages 21 to 45 and 206 women ages 46 to 65, for a total of 374 in an intent-to-treat analysis. Evaluation of the primary endpoint by age group showed that 33% of placebo-treated patients had improvement regardless of age.
Age-stratified response rates differed across the alprostadil dose groups, but a higher proportion of women in each group had improvement compared with placebo. In the 500-µg arm, 49% of older women and 42% of younger women improved. In the 700-µg arm, 46% of younger women and 41% of older women improved.
The highest response rate occurred among younger women randomized to 900 µg of alprostadil, as they reported that 61% of sexual encounters were satisfactory (P<0.005 versus placebo). Older women had a 47% response rate.
With respect to secondary endpoints, younger women randomized to the highest concentration of topical alprostadil derived the greatest benefit versus placebo.
Moreover, only the 900 µg-arm had statistically significant improvement versus placebo for all six domains of the FSFI, regardless of patient age.