By: Tomas Ronolski - AllPennyStocks.com News

Friday, December 20, 2013

To most people, getting old, well…sucks. There are some great things that can only come from age, experience, successes, children, grandchildren, etc., but the wear-down of the body is something that is generally not very enjoyable and fought tooth-and-nail by most. The good thing is that virtually no matter what it is – stiff joints, brittle bones, gray hair, disease – our advertising-rich society let’s us know that there’s a treatment for it. In recent years, a person can barely turn on a television without seeing an ad for hypogonadism, a condition better known by the more-ad-friendly nickname of “Low T,” or low testosterone. Thanks to the massive marketing efforts of biotech behemoths like Abbott Laboratories (NYSE:ABT) with its Androgel product and Eli Lilly (NYSE:LLY) for its drug Axiron, Low T is now a widely publicized condition that is easily treated. These efforts helped drive the U.S. Low T market upward by 30 percent in 2012 to more than $2.1 billion.

Testosterone drugs are not without risk, though. In addition to potential personal side effects, such as low sperm count or chances of hastening prostate cancer, they carry a different type of concern than most drugs as they can affect people around the user. 90 percent of the Low T market is represented by gel formulations where the testosterone is absorbed through the skin, making it possible for other people, for which the drug is not intended, to come in contact with it, which can lead to unwanted side effects. Women and children are especially likely to be affected, with symptoms for women including new hair growth or acne, and kids possibly experiencing signs of early maturation. Pregnant women are at risk of harming the unborn baby.

As such, all of the current testosterone gels have a “black box” warning related to transference to third parties.

Trimel Pharmaceuticals (TSX:TRL) has completed Phase III clinical trials and submitted a New Drug Application to the U.S. Food and Drug Administration requesting marketing approval for its CompleoTRT, a bioadhesive intranasal gel formulation of testosterone. As we wrote in an article in April 2012, the new drug has strong potential because it is applied to the interior lateral wall of the nasal cavity and absorbed completely in 15 to 30 minutes, essentially eliminating the risk of transference to third parties. If approved, Trimel’s drug could avoid a “black box” warning, which may make it more appealing to clinicians and support stronger sales.

The FDA formally accepted Trimel’s NDA for CompleoTRT in July, which gave shares a lift, but it’s been a bumpy ride since as investors await the FDA’s decision. In October, shares plunged from 75 cents to around 40 cents after Trimel received a response letter from the FDA asking the company to clarify several points related to the titration plan in twice-a-day and three-times-a-day dosing of the treatment arm in its Phase III clinical trial. The FDA suggested that Trimel might want to only pursue approval with a three-times-a-day dosing protocol. Investors don’t like hiccups in the regulatory review process and interpreted the FDA questions with cynicism towards potential approval.

After Thursday’s closing bell, Trimel said that it has determined that the most expeditious path to seek approval of CompleoTRT is under the FDA’s guidance. The company is moving forward with a proposed three-times-a-day dosing regimen and is in the process of changing its proposed labels for CompleoTRT to reflect the protocol.

This may be the quickest path to approval, but Trimel is not giving up on the twice-per-day dosing model. "The Company continues to believe that a twice-per-day dose represents a promising alternative for patients with hypogonadism and we are considering options for pursuing approval for such a dosing regimen,” said Tom Rossi, President and Chief Executive Officer at Trimel, in a statement Thursday evening.

Of course, the move to follow the suggestions of the FDA still doesn’t guarantee approval of CompleoTRT, but it may clear the road for an FDA decision without further questions.

Technical traders will note that the TRL chart has formed a “double bottom” pattern with support at 38 cents that should be watched to hold. The last move off of this support in November took shares as high as 62 cents. Thursday’s news may be the catalyst that the stock price needs to rise again from these depressed levels. Proper due diligence is, as always, encouraged.

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