Actual - Real Estate

The most common reasons for refinancing a mortgage are to lower the monthly mortgage pa

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

yment and to lower the interest rate. There are a couple of things to consider when 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

have purchased a home and are considering refinancing. You need to consider how much mo

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

ey you are really going to save when you take into consideration that you have to pay c

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

osing costs and other fees in order to refinance.

Seasoning Period

Most lender

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

Combination pro

s have a clause, which is referred to as the “seasoning period.” This means that you ca

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

not refinance your mortgage until after the first or second year that you have lived in

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

the home.

Early Payoff Penalty

Another cost factor that you need to be aware o

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

is that your existing mortgage lender may charge you a prepayment penalty for paying y

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

our mortgage off early. If you refinance into a new mortgage, the existing mortgage is

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

ssentially paid off with the new mortgage and some lenders charge fees for this. Fees c

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

Following aspects would a

n range greatly, but are usually calculated as a percentage of your mortgage amount, wh

dd to the challenges in developing combination products:

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

ch can cost you thousands of dollars.

Closing Costs & Fees

So before you refin

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

ance your mortgage it is important to calculate how long it is going to take you to bre

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

keven or to recoup the amount of money that it is going to cost you to refinance (closi

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

g costs, prepayment penalties, etc.). This is especially important to calculate if you

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

Professional from academic institutions, pharmaceutical industries, health care indust

o not plan on being in the home for an extended period of time. As long as you recoup a

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

ll of the costs that you will have to put into the refinance before leaving the home, t

.

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

en it may be a good time to refinance.

Breakeven Analysis Formula

Total amo

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

Companies that provide selfless information through particip

nt of savings per month = # of months to breakeven Total amount of refinance cost

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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