Just Answers - Real Estate

For anyone thinking of buying a home, the age old question has always been, what do I get, a fixed rate mortgage or an adjustable rate mortgage or

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

ARM? The truth of the matter is, either mortgage that you get is a gamble and ultimately you have to decide on which end of the gaming table you

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

Examples of combination products may in

want to play. We're going to give you the pros and cons of each as well as the benefits and then hopefully from this information, you can make an

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

informed decision.

First thing we have to do is define what each type of mortgage is. An adjustable rate mortgage, or ARM, is a mortgage that ch

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

nges over time. In other words, when you first get your mortgage it may be, say, 7%. Then, one year later, that mortgage could go up to 8% or it

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

Combination pro

could go down to 6% or any number in between, above or below. There is usually no ceiling or floor to how high or low an adjustable rate mortgage

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

can go.

A fixed rate mortgage is just that. When you take our your mortgage, say on January 1, 2006, for 30 years and the mortgage rate is say,

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

6%, 30 years later when you're about ready to pay off that mortgage, it is still only 6%. In all that time it neither went up or down. That is w

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

y it is called a fixed rate mortgage.

Okay, so why would a person choose one over the other? Well, that depends on a number of factors, almost a

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

l of which are out of each person's control, though some are affected by the person's economic situation.

Initially, what is attractive about an

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

RM is that it is usually a lower rate than a comparable fixed rate mortgage at that particular time. For people who are in a tight financial situ

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

Following aspects would a

ation and maybe just barely qualify for a mortgage, this is an attractive option because initially anyway, they are saving some money on their mon

dd to the challenges in developing combination products:

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

hly payments because the rate is lower than a fixed rate mortgage at that time.

The problem with this approach is this. If economic indicators s

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

ow that interest rates are on the rise, then as time goes on, this attractive interest rate can actually balloon into a rate that is much higher t

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

an the fixed rate mortgage you could have gotten at the same time. So while on January 1, 2006, you could get an ARM for 6% while the fixed rate

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

ortgage is 7%, by January 1, 2009, that ARM could have gone up to 9% or even higher depending on how high interest rates have gone.

In other word

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, it's a gamble. Many people actually choose a fixed rate mortgage because they feel that interest rates ARE going to be on the rise. Then some

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

hing happens and the rates actually start to drop. Now their fixed rate mortgage, which looked so good two years ago, is two or three points high

.

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

r than the same fixed rate mortgage at that time. Sure, they can always refinance, but that has a cost to it too and is a royal pain.

Choosing a

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

Companies that provide selfless information through particip

mortgage is a gamble. Make no mistake about it. The best thing to do is choose your poison and learn to live with the results, whatever they are

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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