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A father / son team of convicted felons actually did this in the early 1990s. The Dominion of Melchizedek, a totally fictitious, sovereign na

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

tion was located on an uninhabited Stoll owned by the Republic of Marshall Islands in the Atlantic Ocean,, off the coast of Columbia, South Am

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

rica. President of this island nation was the son's wife, who reportedly lived in California. It was purportedly a quasi-religious society g

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

verned by a "House of Elders." It had a complete financial system with phony banks and stock exchanges. It sold citizenships, insurance and

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

tock licenses. It sold diplomatic passports, religious grants, business licenses.. And, it had an embassy listing in Washington, D.C., Unbe

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ievably, it was actually "recognized" by an African state. (One can only question what these officials were smoking at the time.) This might

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

little nation even had the boldness to declare war on France for nuclear testing. (The mouse that roared?)

The sum of the Dominion's activi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ies ran amuck. Cataloged by John Shockey, former U.S. Comptroller of the Currency, these included: taking deposits, investment sums and fees

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

and issuing worthless "guarantees." Also, making loan commitments, verifying and "authenticating" values of other Melchizedek entities which

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

issued hundreds of millions of dollars in worthless debt instruments which were used to obtain real money loans and were exchanged in real bro

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

erage houses for real value securities.

Amazing is the fact that--despite excellent, detailed exposure in articles run in Forbes, the Washing

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ton Post, and the Wall Street Journal as long ago as the early 1990s--this monumental scam is still up and running, more than 15 years later.

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

The Dominion's web site--www.melchizedek.com--was clickable as of press time of this News Release. Endless? Limitless fraud? On and on, into

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

perpetuity? Where does it all end? Or, does it? one might ask.

Breakdown of the system in its ability to restrain giant scams seems to be

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

he key to success for this con man's dream. In his book, Six Hours Past Thursday (www.sixhrs.com), author, Jack Payne, goes one application b

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

tter. "This nation-building exercise is entirely illegal," says Payne. "It's blatant, in-your-face, outright crime. From the opposite side of

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the fence my book tackles another broken system," he goes on, "our cumbersome, snail-moving legal system. Converse to Melchizedek, this syste

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

is rife with opportunities for entirely socially acceptable, non-jailable 'legal' crime." His novel weaves the story of how a Chicago mobste

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

, with the aid of a con man, creates such an entity, a gambling island Mecca, ala Monte Carlo, off the coast of Florida.

"From fiction to rea

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ity! How close the gap? Really! And, when you have no moral compass with which to navigate," concludes Payne, "the sky is your only .limit.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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