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Before you decide if you will buy some discount points on your next refinanc

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

e, please do the math!

You have to decide how long you are willing to keep

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

Examples of combination products may in

the mortgage. It is a very simple calculation. If you use 2 points to buy 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.

rate down on a $200,000 mortgage, it will coast you $4,000 in discount poin

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

ts (REAL discount points, be careful and read your Good Faith Estimate!).

L

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

Combination pro

t me show you if your rate goes from 6.5% to 6% with 2 discount points:

Mon

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

thly payment on principal and interest for a $200,000 mortgage loan (30 year

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

Fixed) at 6.5%: $1,264.14

Monthly payment on principal and interest for a $

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

200,000 mortgage loan (30 year Fixed) at 6%: $1,199.10

A difference of abou

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

$65 a month. Now take $4,000 and divide it by $65. It will take you 61.54 m

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

onths (over 5 years) to get your money back and get even (not including the

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

Following aspects would a

other fees you will pay).

Once again, please take the time to read your Goo

dd to the challenges in developing combination products:

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

Faith Estimate (GFE). If your loan officer gives you number over the phone

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

, make sure you ask for your GFE. Make sure you read every line of your GFE

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

and ASK questions. Did I mention to ask questions?

Now it is time for you

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

to get a pen an paper (OK, your computer) and do the math and make sure your

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

Professional from academic institutions, pharmaceutical industries, health care indust

numbers fit your goals (You must have some goals if you are looking at a ref

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

inance?). By the way, you should not buy the rate down on any Adjustable Rat

.

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

Mortgage (ARM)! A very simple reason, if your rate goes up 1 to 2% after t

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

Companies that provide selfless information through particip

he fixed period then you will want to refinance and get a fixed rate.

Enjoy

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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Summer is way too short, so it's no wonder that business slows down for most of us. That's why it's a good time to relax, regroup, and reflect over the past few months. What have you been doing right? What could you improve on? How can you use these next few months to prepare for September? Here are a few things I've done myself that have helped me regain focus and remember why I got into business for myself in the first place.

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