Trimel Pharmaceuticals PDUFA Date am 28-05-2014 sowie PII Daten noch in Q2 - 500 Beiträge pro Seite

[orfmen]

Trimel Pharmaceuticals PDUFA Date am 28-05-2014 sowie PII Daten noch in Q2 --- TRL.TO

Further potential returns in H114 will be geared towards the results of the Tefina Phase II ambulatory trial (Q214) and the FDA’s decision (PDUFA date 28 May) on CompleoTRT.


http://www.edisoninvestmentresearch.com/?ACT=18&ID=11274



For those of you who enjoy research:
http://www.heraldsun.com.au/news/opinion/these-droplets-will… article by Susan Davis re: decline of testosterone in women after 40 etc.

And: Dr. Susan Davis, chair of Women's Health in the Monash University Department of Medicine in Melbourne, Australia, is the lead researcher on the pharmaceutical company Trimel's trials. On the CBC radio program The Current, Davis specified that while she doesn't use the term "disorder," she is adamant that there is a spectrum of sexual dysfunction in women -- where they don't reach orgasm -- that can be likened to impotence in men. She says that denying its existence and medical validity is "sexist [and] inappropriate." Men have Viagra/Levitra/Cialis, and women should have an equivalent option.


Tefina is testosterone in the form of a nasal spray, which, like Viagra, dilates blood vessels. One place that happens noticeably is the genitals, where increased blood flow increases sensation. "This dilation increases the capacity for women to experience an orgasm," Davis told The Current. According to her it's been effective in about 60 percent of patients when used prior to sex. Beyond the physiologic mechanism, interestingly, she says testosterone also "has effects on thoughts, desires, and fantasy." Nov. 2012 The Atlantic magazine

And: “The drug is testosterone-based. It is believed to boost sexual desire by activating certain brain centers and increase blood flow to the female sexual organs.
The researchers say they do not expect Tefina to have any major unpleasant side effects, such as acne, body hair growth or deepening of the voice. They also say they do not expect any unpleasant side effects in women who fail to have a sexual encounter after using the preparation.

According to Professor Davis, "We anticipate the treatment will work like Viagra for women. Rather than a long-term, therapy-based approach, this drug can be taken when a woman anticipates sexual activity. We have previously shown that for women with low sexual interest, testosterone therapy not only improves sexual desire and arousal, but also enhances a woman’s ability to reach orgasm."


And: “According to the Medical Daily website, Davis has also said that Tefina would be "most helpful for patients who say that sex has become a chore rather than a pleasurable experience," and for those women who have sex with their partners just to "maintain relationship harmony," but not out of any real interest.”



...ultrakurzfristig Megagewinn möglich...
....aber auch nicht ohne hohes Risiko....

Biotech ist eben nur etwas für Freunde der Schwarzen Mahoo, die gern auch mal die Peitsche knallen lässt!


Viel Glück!!!


Disclaimer:
Lasst die Finger von Aktien, die ihr nicht physisch in den Händen halten könnt!
Vielleicht gibt es sie ja gar nicht ! ! !

[orfmen]

Trimel completes CompleoTRT market study
http://biotuesdays.com/2012/10/22/trimel-completes-compleotr…



Trimel’s CompleoTRT Phase 3 meets efficacy end points
http://biotuesdays.com/2012/12/06/trimels-compleotrt-phase-3…



Trimel gets positive results from Compleo market survey
http://biotuesdays.com/2013/01/07/trimel-gets-positive-resul…/


Let’s talk about some companies you like and why?
I like Trimel Pharmaceuticals (TSX:TRL), notwithstanding the selling pressure from its founding shareholder, because it has a better solution for the delivery of a topical treatment of low testosterone in men. The sleeper is that it has the same delivery system for women, where there is a major unmet medical need for female orgasmic disorder.

Tony Pullen


CompleoTRT™ Overview
Trimel's most advanced product candidate, CompleoTRT™, is a nasal gel formulation of testosterone. CompleoTRT™ is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.

Trimel has concluded a comprehensive clinical development program for CompleoTRT™, announcing top line Phase III efficacy results in December 2012. The Corporation's and external experts analysis of the Phase III clinical trial efficacy data is based on results from 306 patients who participated in the study.

On July 9, 2013, Trimel announced that the CompleoTRT™ New Drug Application ("NDA") was formally accepted by the United States Food and Drug Administration ("FDA"), which was filed on April 29, 2013. Following the submission of an amended dosing protocol and associated label change in December 2013, the FDA has confirmed that under the United State Prescription Drug User Fee Act, the target action date for the NDA is May 28, 2014.

Subject to the approval of the FDA, CompleoTRT™ is designed to be applied to the interior lateral wall of the nasal cavity, where studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the “no touch” targeted delivery to the nasal mucosa, CompleoTRT™ should avoid skin-to-skin transference to third parties, a health risk that led the FDA to issue a “black-box” warning in May 2009 for secondary transference for all topical testosterone gel preparations.

To date, the FDA has not asked Trimel to conduct any patient transference studies, supporting the Corporation’s expectation that the CompleoTRT™ label will not contain a “black box” warning. When comparing CompleoTRT™ versus currently marketed topical testosterone gel preparations, the Corporation believes that in addition to the avoidance of skin transference issues, enhanced patient compliance may be derived from the ease of application, the lack of any mess or odour from the gel, as well as the convenient dosing via the novel multi-dose nasal dispenser.

http://trimelpharmaceuticals.com/Products/CompleoTRT-Overvie…

[orfmen]

Es herrscht vorsichtiger Optimismus auf dem Weg zur Startrampe.
Wenn die zockverliebten Amis morgen aus dem Wochenende erwachen, gibt es kein halten mehr.

Hier ist mehr Potential vorhanden, als ich noch als jugendlich - leichtgläubiger Typ dachte.
Es wird (vor)getäuscht und getrickst, die Dunkelziffer in Tefinas Indikation könnte gigantisch sein.
Kaum geliefert, schon vergriffen, ein Verkaufsschlager.
So wird es kommen!


(oder auch nicht)

Ach so, die Zulassung für Compleo???
Nehmen wir morgen so im Vorbeilaufen mit!

Disclaimer: Bin investiert, sonst würde ich mich hier nicht so abrackern!
Aktien können steigen oder fallen, manchmal schneller als es das menschliche Auge überhaupt wahrnehmen kann!

Gruß

[kwhistler]

Antwort auf Beitrag Nr.: 47.048.292 von orfmen am 26.05.14 18:45:45

Servus,
...das Viagra für die Frau hatte ich letzte Woche schon auf dem Radar!! Aber leider nicht getraut hier rein zu gehen!! Wäre mal besser gewesen als bei Oramed zu bleiben - das wird aber wieder!!!
Naja beobachte noch!

LG aus WI

;-)

[pRoFeX1337]

Klingt interessant... Die Frage ist ob man noch vor US Handelsstart einsteigen sollte.

[orfmen]

Wäre wohl keine so gute Idee gewesen vor Handelsbeginn, sorry.
Ich hoffe, falls du eingestiegen bist, du konntest den Abverkauf nahe des Tiefs erwischen.
Definitiv nichts für schwache Nerven, wie bereits erwähnt, nur für Leute die Schmerzen gewöhnt sind.

Dieses wilde Gezocke in alle Richtungen ist nichts ungewöhnliches vor diesen Ereignissen.
Daraus kann man kaum etwas lesen, leider.

Gehe erstmal wieder offline für einige Tage, ich drücke allen hier Investierten die Daumen für die Entscheidung und für gute PII-Daten.
Wir sehen uns dann bei 2,1 $ oder bei 21 cent wieder.
Viel Glück!

[pRoFeX1337]

Bin bei umgerechnet 0,463 € eingestiegen.

Alles viel Glück!

[Mordecai]

Geht hier was nach der heutigen Nachricht? Bin da noch eher skeptisch

[TheKnife]

Abwarten bis 16:30, denke ich

Vorbörslich in Frankfurt 2,40 € hinblättern tut wohl keiner

[pRoFeX1337]

Hmmmmmm. Also kurz Wagens mal einige Prozent plus.. Aber nu

[Traumtaenzer]

FDA Approval erfolgt.

http://trimelpharmaceuticals.com/News/ID/117/Trimel-Receives…

[orfmen]

Trimel Pharmaceuticals Announces Positive Phase II Results for Tefina™


Women treated with Tefina™ 0.6 mg reported a statistically significant increase in orgasms versus placebo
Trimel Pharmaceuticals Corporation
May 28, 2014 6:30 AM
TORONTO, May 28, 2014 /PRNewswire/ -- Trimel Pharmaceuticals Corporation (TRL.TO) announced today top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina™, a "use-as-required" testosterone nasal gel for the treatment of Female Orgasmic Disorder (FOD). FOD, also known as anorgasmia, is characterized by a delay, absence or reduced intensity of orgasm, causing clinically significant distress.

The double-blind, placebo-controlled study enrolled 253 pre- and post-menopausal women experiencing acquired FOD in the United States, Canada and Australia. Participants were randomized to one of three dosage strengths (0.6 mg, 1.2 mg, 1.8 mg) or a placebo group and treated over the course of 84 days. The primary endpoint of the study was to compare the effects of the three dose strengths of Tefina™ nasal testosterone gel to placebo on the occurrence of orgasm. Secondary endpoints included the change from baseline in distress due to orgasmic disorder, change in sexual functioning and sexual event satisfaction. Safety and tolerability were also assessed.

Tefina™ 0.6 mg led to a statistically significant increase in the average number of orgasms during the 84-day treatment period of 2.3 versus 1.7 for the placebo arm (p=0.0015). In addition, improvements in all of the secondary endpoints were observed; however, further analysis is underway to assess statistical significance. Tefina™ was found to be well-tolerated with no reported serious adverse events.

"Female Orgasmic Disorder is the second most prevalent sexual disorder affecting women. Approximately one in five women report difficulty with orgasm and one quarter of these show marked distress, a key criterion in a clinical diagnosis," said Dr. Sheryl Kingsberg, the U.S. principal investigator for the Tefina™ Phase II clinical trial, chief of behavioral medicine at University Hospitals Case Medical Center and professor of reproductive biology and psychiatry at Case Western Reserve University in Cleveland, Ohio. "Currently, there are no approved pharmacological treatment options, leaving an unmet need that Tefina™ hopes to remedy."

"These results mark an important milestone in the development of Tefina™," said Tom Rossi, Trimel President and CEO. "They provide further evidence that Tefina™ could represent an important treatment option for the many women who suffer from this disorder. On behalf of Trimel and its various stakeholders, I am extremely excited about this positive outcome and look forward to advancing this product towards commercialization."

Investor Event

Trimel is pleased to announce that it will host an Investor Event on Thursday, June 12, 2014, from 12:30 - 3:00 p.m. (Eastern Daylight Time) to provide a more in-depth review of the Tefina™ Phase II study results. Dr. Kingsberg, U.S. principal investigator for the Tefina™ Phase II clinical trial, will be the keynote speaker at the event. The Investor Event will be held at the Toronto Region Board of Trade, First Canadian Place, Suite 350, 77 Adelaide Street West, Toronto, Ontario and by webcast. For more information or to register for the event, contact [e-mail] or visit http://trimelpharmaceuticals.com/Investors/Investor-Day. In-person space is limited.

About Female Orgasmic Disorder

Female Orgasmic Disorder, also known as anorgasmia, is characterized by a marked reduced intensity of orgasmic sensations, or marked delay in, marked infrequency of, or absence of, orgasm that has persisted for a minimum duration of approximately six months, and causes clinically significant distress in the individual. The diagnosis is further specified by whether the dysfunction has been lifelong or acquired. Currently, there are no approved treatments for Female Orgasmic Disorder.

About Trimel

Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. A New Drug Application for CompleoTRT™, a product utilizing Trimel's licensed nasal gel technology, has been filed with the United States Food and Drug Administration and is awaiting regulatory approval. For more information, please visit www.trimelpharmaceuticals.com.

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 5, 2014 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

[pRoFeX1337]

Warum bröckelt eigentlich der Kurs immer weiter.. ist doch alles super

[pRoFeX1337]

US FDA approves Trimel Pharma's Natesto nasal gel to to treat men with low testosterone

Toronto
Monday, June 02, 2014, 18:00 Hrs [IST]
The United States Food and Drug Administration (US FDA) has approved Trimel Pharmaceuticals Corporation's Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator thereby minimising the risk of secondary exposure to testosterone of women or children.

“In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages,” said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida (CRSA). “For these patients seeking to restore their testosterone levels, Natesto will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market.”

It is conservatively estimated that nearly 13 million American men may have low testosterone levels. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections, oral tablets, as well as a buccal patch.

“The US FDA approval for Natesto is a major achievement for our company, as it validates our clinical research and development efforts, as well as reinforces our commitment to provide innovative treatment options for patients,” said Tom Rossi, Trimel Pharmaceuticals Corporation president and chief executive officer, “Men suffering from “Low T” will now have a different option to raise their testosterone levels. This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children. We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it.”

Male hypogonadism, or low testosterone, is a condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone and testosterone secretion. Signs and symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and regression of secondary sexual characteristics.