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People who are seeking financing often times shop lenders. Shopping lenders can mean two things:

1. Applying with multiple

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

lenders simultaneously within a short period of time.

2. Applying for a loan with a lender, getting denied the loan and reap

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

Examples of combination products may in

lying with another lender.

Now here’s the problems with this approach to getting the money you need.

In either case, every

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

lender you apply with is going to do a credit inquiry on you to check out your credit using what is called an in-file credit

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

eport. When a lender queries your in-file credit report, there is a notation on the credit report that leaves a track record

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

Combination pro

of the lender performing the inquiry: lender name, date, that kind of thing.

Lets take the first case scenario, number 1 abo

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

ve: Let’s say you have a middle of the road commercial real estate deal and you are seeking financing for a small strip shopp

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

ng center. It’s a fairly good project but not great. When you shop lenders (banks and brokers) by communicating with multip

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

e lenders, they will look at your credit file and wonder who has control of this deal. Too many lenders looking at your proj

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

ect at the same time can kill the deal, especially when using brokers who cross wires with lenders. This can be bad news for

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

the borrower.

The second scenario, number 2 above: Let’s say you are seeking a debt consolidation loan and you apply with a

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

Following aspects would a

ender who denies you. So, in your infinite wisdom, you apply at another lender who also denies you, and a third and maybe a

dd to the challenges in developing combination products:

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

fourth or more. Knowing what you know now, you will realize that each lender will see that the last lender denied you a loan

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

(or you wouldn’t be applying with the current lender, right?) Each lender will question why the last lender didn’t do your de

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

l and red flags will start waving in the lender mind: If bank A didn’t do the deal, what’s wrong with the deal? And this proc

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

ess gets worse with each successive lender who looks at your file. They won’t do the deal because the other banks didn’t do

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

Professional from academic institutions, pharmaceutical industries, health care indust

he deal and that means there must be something wrong with you or your project, whatever it is. It’s a chain reaction.

The ke

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

is in knowing which type of lender is the best lender to approach for financing FIRST. Many borrowers don’t have this infor

.

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

mation and end up approaching the wrong lender for financing and screwing up their chances for funding.

It’s what you don’t

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

Companies that provide selfless information through particip

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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