Answers - Real Estate

You’ve recently bought a home and you are already wondering about refinancing. Fir

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

st, you want to know when you can do it, which is simple: you can do it the day af

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

Examples of combination products may in

er you sign the papers. However, that may not be a wise decision. Here are some th

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

ngs to consider before looking into refinancing:

1. Do You Have a Prepayment P

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

enalty (PPP)?

Because lenders take a risk when lending you money, they expect

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

Combination pro

a certain amount of financial return. To ensure this return, lenders can institute

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

a prepayment penalty (PPP) on your loan that can cost you thousands of dollars if

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

you pay the mortgage off in full during a certain time frame, usually two or three

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

years. Refinancing during your PPP term can cost you as much as 5% of your initial

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

loan amount.

2. Do You Have Enough Equity?

For recent homeowners, it is u

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

likely that you have much equity, especially if you did not put much down. Of cour

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

Following aspects would a

se, if you made a considerable down payment or got a great deal you could access t

dd to the challenges in developing combination products:

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

at equity immediately; however, it may be costly to pay closing costs on another l

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

an so soon.

3. Is the Cost Worth It?

Even if you have equity to refinance

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

, you still have to ask yourself if the costs are worth it. If you are trying to s

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

ve money, you have to project a break even point, i.e. the point when your savings

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

Professional from academic institutions, pharmaceutical industries, health care indust

covers the closing costs of the refinance. If that break even point is more than t

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

wo years in the future, it is probably not worth refinancing.

You certainly have

.

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

he ability to refinance when you wish, but you should consider the aforementioned

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

Companies that provide selfless information through particip

autions before leaping to a financial decision that may do you more harm than good

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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