Zeev's Turnips Patch-No Politics (ZEEV)

[marquis103]

George. I'm certainly no expert but I think this article, which has more info than the one you posted, answers a couple of your questions. It would appear full approval could take up to a year, and actual sales would be another year down the road. Hope this helps. Russ

http://biz.yahoo.com/djus/030612/1444001059_2.html

Dow Jones Business News
NexMed Shares Higher on Positive Impotence Cream Trials
Thursday June 12, 2:44 pm ET
By Amy Braunschweiger


NEW YORK -- NexMed Inc.'s shares set a second straight 52-week high Thursday after two Phase III studies showed its erectile-dysfunction cream, Alprox-TD, effective.
Kenneth Anderson, NexMed's vice president of commercial development, said the company plans on filing a new drug application for Alprox with the Food and Drug Administration (News - Websites) in the first half of 2004.

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But first, the pharmaceutical and medical-technology company will initiate a long-term study of the product, beginning "almost immediately," Mr. Anderson said. The long-term study will last a year, but the company can begin to submit information to the FDA after only six months.

If approved by the FDA, NexMed expects the cream to hit shelves 12 months later, company representative Deborah Carty said. The Robbinsville, N.J.-based company is in talks with "about a dozen" large and mid-sized pharmaceutical companies to help it market Alprox-TD.

"Certainly (the companies) will look upon these results as very favorable," Ms. Carty said about the Phase III trials.

In afternoon trading on the Nasdaq National Market, shares of NexMed jumped 80 cents, or 31%, to $3.40. Earlier, shares rose as high as $4.23, above a 52-week high of $3.14 set Wednesday.

Earlier Thursday, NexMed said the cream showed a "highly significant" increase in erectile function.

NexMed's cream hasn't been compared with oral medications for erectile dysfunction, Ms. Carty said.

The cream, however, begins to work between 10 minutes and 15 minutes after it is applied, while pills can take two hours to begin working.

"It's truly an on-demand product," Ms. Carty said.

In addition, men taking nitrate medications, such as heart medication, also can use the cream. Taking medication containing nitrates isn't recommended for patients using erectile-dysfunction pills. The cream is safe to use with a condom, Ms. Carty said.

- Amy Braunschweiger, Dow Jones Newswires; 201-938-2205; [e-mail]