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It use to be said that once a company was de-listed from the NASDAQ it was the kiss of death

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

, not so any more. With Sarbanes Oxley and all the insane reporting requirements it might sa

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

Examples of combination products may in

e your company from incessant lawsuits from investors and the government regulators who are

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

ut to destroy free enterprise. Many small NASQAQ companies have spent over $100,000 initiall

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

y to set up the controls for accounting compliance of Sarbanes Oxley and now the ongoing scr

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

Combination pro

tiny for transparency runs a good 1-3% of gross sales. But that is not the kicker; the real

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

roblem is when company executives make decisions for the regulator over sight compliance and

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

what is best to keep the company out of trouble or from receiving a letter from Elliot Spit

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

er or the SEC. Once that happens the stock price tumbles and once in the sites of a regulato

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

they are going to have to find something to prove self worth, even if they have to lie a li

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

tle or fudge their investigation to make something up. Which is all to common as any insider

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

Following aspects would a

will tell you.

A company which is delisted or deregistered stands to have an instant gain

dd to the challenges in developing combination products:

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

n their bottom line and will have the advantage of making decisions based on market advantag

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

and profit goals rather than appeasing brain dead regulators and thousands of pages of new

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

rules with millions of pages of new case law.

Some companies are seriously thinking of goin

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

private, not going public. Being de-listed now is no longer the kiss of death but rather it

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

Professional from academic institutions, pharmaceutical industries, health care indust

breaths new life blood into a stagnant innovative company that has turned bureaucratic due t

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

o Sarbanes Oxley. One CEO we talked with said that he feels the need to call the his lawyer

.

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

f he wishes to use the restroom to make sure it is legally safe and once in the commode take

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

Companies that provide selfless information through particip

a clip board to insure he correctly counts the toilet tissues used. Think on this absurdity

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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