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post Posted: Dec 4 2004, 07:01 AM
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QUOTE (traveler @ Saturday 04/12/04 02:07am)

The FDA didn't just "reject" Proctor and Gambles drug, it said further research was needed because it is a testosterone patch that could increase the risk of breast cancer, heart disease, stroke, etc. They have only had short term studies on a limited number of women and "Panel member Dr. Steven Nissen, a Cleveland Clinic Foundation cardiologist, said he worried about exposing millions of American women to heart attack and stroke risks to gain a marginal increase in sexual satisfaction."

Furthermore, "The results of long-term studies by the Women's Health Initiative, a program established by the National Institutes of Health, loomed large. That project found that postmenopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer."

EpiTan is a completely different form of drug, and instead of increasing sexual desire in 15% of patients it reduces sun damage by as much as 50% and increases melanin production by up to 100%. It helps prevent people from dying, where P&G's drug increases sexual desire... and melanotan has been around for years, tested in Arizona years ago, and there have been no known long term side effects. The risk to reward for preventing skin cancer is much higher than the risk to reward for increasing sexual desire.

Here's a good article on P&G's drug
WASHINGTON (AP) -- In a move that could chill excitement about experimental drugs to treat female sexual dysfunction, federal advisers refused to endorse a new testosterone patch for women.

Procter & Gamble sought to market the Intrinsa patch to women with impaired libido due to surgical removal of their ovaries. The company told a Food and Drug Administration advisory panel that the drug had not raised significant safety concerns in clinical trials.

However, the advisory committee was unanimous Thursday: More research was needed.

The FDA is not bound by the committee's recommendation, though the agency usually follows such guidance. An FDA decision on Intrinsa is expected in a few weeks.

Panel member Dr. Steven Nissen, a Cleveland Clinic Foundation cardiologist, said he worried about exposing millions of American women to heart attack and stroke risks to gain a marginal increase in sexual satisfaction.

Clinical trials showed that women who applied the patch to their abdomen twice weekly had one more "satisfying sexual event" per four weeks than did women given a placebo, according to the data presented to the advisory panel.

Nissen said Procter & Gamble needs to study at least 5,000 women for several years to see if the testosterone patch unacceptably raises cardiovascular risk. Heart disease is already the No. 1 killer of American women.

Nissen acknowledged the drug's potential. "The number of men who take Viagra is enormous," he said. "Why would women be any different? I think there's a huge demand for this agent."

Still, agency officials noted a lack of controlled safety data for women who had used Intrinsa longer than six months.

Procter & Gamble said in a statement it would work closely with the agency "to agree on a practicable approach to provide additional safety data."

The results of long-term studies by the Women's Health Initiative, a program established by the National Institutes of Health, loomed large. That project found that postmenopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer.

Lisa Soule, a medical officer in FDA's division of reproductive and urological drugs, said short-term clinical trials for Intrinsa are inadequate.

Soule dismissed Procter & Gamble's suggested post-marketing study that would compare rates of cancer and cardiovascular disease in 5,500 women expected to use Intrinsa in the first year against matching women from a database of 10 million patients.

The Women's Health Initiative, by contrast, had to enroll nearly 17,000 postmenopausal women to begin to detect the safety problems with hormonal therapy, Soule said.

Because hormone replacement therapy definitely increases the risk of development of clots in blood vessels, federal adviser Dr. Charles Lockwood wanted more data on blood clotting differences with Intrinsa.

"I think if there is one single element of safety that deserves the most scrutiny, it is the potential role of this patch in promoting" blood clotting, said Lockwood, an expert in maternal fetal medicine at the Yale University School of Medicine.

Up to 3 million women whose ovaries had been removed would have been eligible to use Intrinsa, according to the company. However, it was widely expected that Intrinsa would have been used by other women who wanted to increase their sex drive with a drug hyped as a female version of Viagra.

Joan Meyer, senior director of new drug development for Procter & Gamble, told the panel the company will soon have more safety data adding information for nearly 200 women who have used the patch for one year.

The company will also provide safety data on 100 more women who have used the patch for 18 months. Eighty women have been using the product for three years.

Unlike Viagra, which enhances men's physical ability to have sex, Intrinsa boosts women's desire for it. Removal of ovaries can cause women's testosterone levels to drop by 50 percent. Although men make more testosterone, women need some to have normal sex lives, experts say.

Fifteen of every 100 women who used Intrinsa experienced a beneficial effect due to testosterone, Dan Shemas, director of the FDA's division of reproductive and urologic drugs, told the panel.

By a 14-3 vote, federal advisers said that benefit, compared with a placebo, was "clinically meaningful."

post Posted: Dec 4 2004, 06:57 AM
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In reply to: kacy on Saturday 04/12/04 05:37am


Based on discussions on Ozestock, which I would quote if they had any kind of search function, I understood the Hatch Waxman Act grants extensions only if a produce has been marketed before the patent expires. Could anyone clarify?



B.A.T.S. - Biota Army of Ticked-off Shareholders This is just the opinion of an angry Biota shareholder
post Posted: Dec 4 2004, 06:30 AM
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In reply to: polyphemus on Friday 03/12/04 09:24pm


Are you able to tell who the selling broker was, and if it was a discount broker, can you idenify the code of the broker ? I spoke to a broker last week around this time who had a chat with Millen and he reassured me things were more than positive.

post Posted: Dec 4 2004, 06:26 AM
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Posts: 216

In reply to: traveler on Saturday 04/12/04 05:09am

VOLUNTARY ESCROW - I certainly hope that the good doctor is more serious about his statement this time around.

Refer to the attached news release from May 2004 - remember this.

'No intention to sell any more this year.' - Well clearly his intentions have changed.
This is still 2004 isn't it.

I'm holding my head high - after all i was one of the very few who did vote against the latest round of options voted upon at the AGM.

Actually the sale of the shares themselves is certainly no biggie but i do believe that the Doc should not conduct his selling in a manner contradictary to his own prior statements.

Thankfully my investment is in the product and i do not believe that it is essential that this fellow is at the helm in order for us to succeed.

Wake up team! Time you started to deliver progress not promises .
Attached File(s)
Attached File  EPT_Share_Sale.pdf ( 184.58K ) Number of downloads: 178


post Posted: Dec 4 2004, 05:09 AM
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Posts: 684

In reply to: kacy on Friday 03/12/04 12:37pm

Very informative post, Kacy.

Your inpunt on this board on a regular basis would be a welcome addition.

post Posted: Dec 4 2004, 04:37 AM
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In reply to: jumper on Friday 03/12/04 06:06pm


The patent position of EPT is secure due to the Hatch Waxman Act. In the US, the government has an act called the Hatch Waxman Act which allows the patent period of a drug to be extended for up to 5 years to compensate the company for the time taken to comply with the FDA's approval requirements. So under this act EPT would get 5 years exclusive market access with their product to US markets. Similar acts apply in other countries including Aus with longer extended exclusive access periods. This should be enough time for EPT to make quite a bit out of Melanotan before the generic brands become available. EPT also expects to have the drug delivery methods patented to further extend their monopoly on Melanotan. IMO a director selling 3% of his shares is nothing to worry about. The recent dip is more likely due to regulations preventing companies from releasing sp sensitive announcements near to Change of Director's Interest announcements. Daytraders always sell when these announcements happen. Expect the sp to recover quickly.


Said 'Thanks' for this post: shane  

post Posted: Dec 4 2004, 02:33 AM
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in a lot of cases .the shares go up after the directors sell a few .when they get to $1.50 .it dont look to bad ///////////.

post Posted: Dec 4 2004, 02:11 AM
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Posts: 684

QUOTE (cali_trader @ Friday 03/12/04 01:30am)

You'll be out at LESS than .16 if there's any major problems in the trials.

I don't think it will happen, but I wouldn't get blase about it. Not with the CEO hedging his own bets on something that he knows better than anyone else on the planet.

post Posted: Dec 4 2004, 02:07 AM
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In reply to: stoss69 on Friday 03/12/04 08:10am

I'm more than a little p.o.'d about how Millen blue-skies us in all media interviews, then turns around and sells 500k, even if that is only 3% of his holdings, that is almost criminal to me.

He tells everybody who will listen what great things are around the corner, then repeatedly doesn't meet deadlines, and then 6 weeks after his latest snowjob on the investors, he unloads 500k.

This guy needs to go.


Yesterday was just a bad day all around. I'm sure most of you here in the States heard about the FDA committee rejecting the female version of Viagra. Procter and Gamble, the maker of that patch, was shocked by the FDA's decision.

That just sent shivers up my spine. We might think that Melanotan is a slam dunk, but I'm telling you that these FDA panelists are totally unpredictable, and could do something totally incomprehensible and reject the final Melanotan approval for the U.S. market (assuming we even get that far).

Based on what the FDA just did to Procter and Gamble, I'm selling about 15% of my shares right after Phase III begins. Never underestimate the FDA. I'm telling you, these guys could end up being our worst nightmare.

But right now, I couldn't agree more that Epitan is lucky to have any shareholders at this point the way they treat those who have gambled on them. It's just a shame that such a great technology is in the hands of an Aussie company that is run by an unscrupulous CEO like Millen.

Unscrupulous? Too strong a word? Hell no. Not for a guy who sells down right after he promises everyone that good things are right around the corner.

post Posted: Dec 4 2004, 01:55 AM
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In reply to: traveler on Friday 03/12/04 09:54am

Given that he's "AOL"? I meant to say, given that he's MIA.

Wow, too many eggnogs for me last night. Is it still December?


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