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FDA Late or they sent a Complete Response letter and rejected compleotrt and trimel has yet to respond. Lets hope the fda is late
Indeed. On approval revenue will soon exceed expenses which makes this company profitable before Tefina gets to the market. $4 is a good estimate for very soon
Trimel Pharmaceuticals Announces Positive Phase II Results for Tefina(TM)Font size: A | A | A
6:30 AM ET 5/28/14 | PR Newswire
Trimel Pharmaceuticals Corporation (TSX: TRL) announced today top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina(TM), 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) hopes to remedy."
"These results mark an important milestone in the development of Tefina(TM)," said Tom Rossi, Trimel President and CEO. "They provide further evidence that Tefina(TM) 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(TM) Phase II study results. Dr. Kingsberg, U.S. principal investigator for the Tefina(TM) 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 rachael.factor@fleishman.ca or visit http://trimelpharmaceuticals.com/Investors/Investor-Day. In-person space is limited.
POSTIVE PHASE 2 up 14% in Canada.... 14K of volume get ready to rumble.
nice now need fda approval for CompleoTRT and this going to pop.
Indeed. My target is 2 CAD/share
FDA decision announcement probably after hours like in 90% of the cases.
Positive results for Phase II trial in female orgasmic disorder. Announced on PDUFA date, highly suspect. How about announcing PDUFA results.
Had been trying to sell since Friday, Schwab being dicks, took until today.
Would have been nice to get some of the action over on TSX. But bought this one on OTC.
Out half. Hold half for PDUFA fron $0.45.
someone dumped 100000 shares in one block causing stop losses to be hit, wasnt much support between .7 and .63
Cant see this not being approved, worst case is a delay...
Also Manulife Securities Incorporated have dumped shares for the past week, anybody have a total
Bid looks stacked before open. Last day before PDUFA.
Watching the price action on Toronto exchange. Looking good.
It is unreal this is at the price where it is even @ $1
looking good, started a position at .60, up 20% so far. Cant wait until next week
This stock is gonna rock.
Picked up some on both TRL.V and TRLPF,
GOT TO LOVE THIS BELOW $1
"PDUFA Date May 28 for CompleoTRT & Important Phase 2 results also in this Month for Potential Blockbuster Tefina .. This Stock has 100-200% in near term Potential .GL
After years of development and clinical trials, the NDA final step is nearing an end with the PDUFA of May 28. All the hard work and sacrifice is looking to pay off in a big way in 2014.
Most shareholders are in this at a much higher level than the current price. Everyone knows there is a big event coming soon (FDA decision) and an approval from the FDA will be huge for this stock.
Testosterone is a well characterized molecule, thus the regulatory requirements for approval are less stringent than a typical NCE (new chemical element).
Topical gels are primarily used to treat Low "T" in the US and run the risk of transference to family members. Thus, all of the products have black box warnings. If approved, CompleoTRT has a much lower risk of transference and is unlikely to have the warning. This distinguishing characteristic should aid in marketing efforts once approved.
The US Testosterone market is very large and relatively untapped. The US market is currently valued at $2 Billion and growing despite only about 10% of addressable men currently treated.
The top selling low "T" drug is Androgel which had a staggering $1.373 Billion in sales over the past 4 quarters, in the US alone !
This stock is tightly held with First Generation Capital and other insiders holding more than half the shares.
RBC Capital Markets gives the stock an Outperform rating with a 12 month target of $1.50. I think this is low. I could see TRL over $2.00 with an FDA approval of Compleo and the naming of a good partner.
On top of all this, Tefina (which is the equivalent of female viagara) with blockbuster potential, is nicely developing in the wings.
Lots to like here with the FDA to make a decision by May 28."
This is a quote from BIOHERO ON A GERMAN STOCK BLOG
Better yet, its ANI + PFE viagra on steroids.
Love the hypogondism drug and the femal sexual disfunction drug, if this goes its gonna be way bigger than RBS's baby quote of $1 CA
The late night DD is in this thing is gonna be sick.
The company has all the BPAX style technology, and is in Canada and PFUDA date right here, are you kidding?
Just bought 1900 SHRS right off the Canadian Stock exchange in Canadian dollars, if this was a USA stock right to $4 IMO.
Big buys for Trimel in Toronto!
So, your target is $1.50 on approval May 28?
Why are more people not in this???
I just got in yesterday, and while I'm happy keeping this our little secret for a while, people are going to be kicking themselves when TRLPF gets back to at least .80 when the news about the pdufa comes out...plus other products in the pipeline.
Long term this is a takeover target.
$27M cash. $1.9M burn per month. The company believes it is well funded thru 2014.
Looking good here.
PDUFA Date May 28 for CompleoTRT & Important Phase 2 results for Potential blockbuster Tefina .. This Stock has 200-300% in near term Potential .GL
After years of development and clinical trials, the NDA final step is nearing an end with the PDUFA of May 28. All the hard work and sacrifice is looking to pay off in a big way in 2014.
Most shareholders are in this at a much higher level than the current price. Everyone knows there is a big event coming soon (FDA decision) and an approval from the FDA will be huge for this stock.
Testosterone is a well characterized molecule, thus the regulatory requirements for approval are less stringent than a typical NCE (new chemical element).
Topical gels are primarily used to treat Low "T" in the US and run the risk of transference to family members. Thus, all of the products have black box warnings. If approved, CompleoTRT has a much lower risk of transference and is unlikely to have the warning. This distinguishing characteristic should aid in marketing efforts once approved.
The US Testosterone market is very large and relatively untapped. The US market is currently valued at $2 Billion and growing despite only about 10% of addressable men currently treated.
The top selling low "T" drug is Androgel which had a staggering $1.373 Billion in sales over the past 4 quarters, in the US alone !
This stock is tightly held with First Generation Capital and other insiders holding more than half the shares.
RBC Capital Markets gives the stock an Outperform rating with a 12 month target of $1.50. I think this is low. I could see TRL over $2.00 with an FDA approval of Compleo and the naming of a good partner.
On top of all this, Tefina (which is the equivalent of female viagara) with blockbuster potential, is nicely developing in the wings.
Lots to like here with the FDA to make a decision by May 28.
Got to pound the table here easy 50% by May PDUFA!
Financing for $10.5 M was done at $0.71. Just a few months ago!
Triple my position here at $0.45. Easy 1 month 50% gainer. PDUFA end of May. $0.75 easy. Maybe $0.85-90.
These TSX stocks fly way under the radar until news breaks. I doubled on NRIFF, 80% on ADHXF and doubled the last time this ran.
Load up!
Holding up well with entire bio sector tanking.
Corporate presentation
http://www.trimelpharmaceuticals.com/Portals/0/IR%20-%20%20February%202014.pdf
Got in a little early. Able to avg down to .68. I can wait for my 50% return.
Back in today at $0.64.
Played this one a few months ago to original date. Ran awesome then.
Trlpf Pdufa
Market Wire
— 7:55 AM ET 01/17/2014
TORONTO, ONTARIO -- (Marketwired) -- 01/17/14 -- Trimel Pharmaceuticals Corporation (TRLPF
) today announced that the United States Food and Drug Administration ("FDA") has decided to extend the Prescription Drug User Fee Act (PDUFA) target action date for the CompleoTRT™ new drug application ("NDA") from February 28, 2014 to May 28, 2014. This will provide the FDA with the required time for a full review of the submission in light of the previously announced decision by the Company to amend its proposed label.
"As the FDA considered the change in labelling a major amendment, we understand that this extension is consistent with their normal practices in these circumstances," stated Tom Rossi, President and Chief Executive Officer. "We will continue to work closely with the FDA in order to obtain approval for this important therapy as quickly as possible."
About CompleoTRT™
Trimel's most advanced product candidate, CompleoTRT™, is a bioadhesive intranasal 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.
About Trimel
Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT™, a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA for regulatory approval in the United States. 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, including that CompleoTRT™ may not be approved by the FDA or that any approval may be delayed, 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 prospectus dated April 18, 2013 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.
Trimel Pharmaceuticals Corporation (TRLPF
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Kenneth G. Howling
Chief Financial Officer
(416) 679-0536
ir@trimelpharmaceuticals.com
www.trimelpharmaceuticals.com
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