Why do we need approval for Qnexa? Why can't other doctors try what Dr Thomas Najarian had been for years?

Dr Thomas Najarian seems to be doing that successfully for years

If that is legal why do we need to get FDA approval for Qnexa?

What is stopping other doctors from trying similar treatment especially with phentermine and topiramate?

Why would VVUS think it can sell the combo successfully if other can use it without FDA approval?

Any board certified doctor can try the combo, what is stopping them from doing that?


http://www.najariancenter.com/patient.information.html

What weight loss should you expect?

As long as you follow the program, you can expect to continue gradual weight loss for up to 24 months on medication. The weight loss should exceed 15% of your starting weight. Thus, if you weigh 200 pounds, you might expect to lose at least 30 pounds in a period of 12-18 months. In addition, a weight loss maintenance phase is instituted once the desired weight loss has been achieved.

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Excellent comments by "wichhazl"on YMB

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=181010&mid=181195&tof=7&rt=1&frt=2&off=1

Their "invention" of Qnexa is just a poor pretext, trying to cover how easy it is to induce the same effects with the generics. The pre-Phase III trials just gave phen in the morning -- to rev metabolism & inhibit appetite during the day, but so it would wear off by night-time to prevent insomnia. Then they took top in the afternoon, to keep a lid on appetite in the evening.

Actually, besides being much cheaper to do it that way, it also offers more flexibility in prescription. A doctor could give more or less of either drug to try to optimize benefit & minimize side effects, based on a particular patient's medical history.

It is true, of course, that a lot of doctors won't monkey around with this, & would rather just prescribe Q -- it would limit their liability, for one thing. The birth defect lawsuits will go straight to Vivus.

But, when patients are dismayed because they can't pay the high price of the prescription, many doctors will let them take the generics.

The patent lawsuits haven't even started yet. Qnexa is such a joke & a fraud. The market will realize this eventually.

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