Advice Pool - Real Estate

Each state has different wording on the form, but it all comes down t

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

o disclosing the terms and conditions of the lock. The form will spel

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

Examples of combination products may in

out the loan program, loan amount, loan type, interest rate, origina

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

tion fee, number of lock days and lock expiration. Some even charge a

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

up front non-refundable fee.

Closing on time means that the lender

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

Combination pro

must disburse the funds by the expiration date. But what happens if t

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

e lender does not close on time? The lock agreement should clearly st

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

ate what would happen. The loan will probably be locked at the higher

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

of the previous lock price or current pricing. In rare cases the loan

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

program could be discontinued altogether.

Make your application jou

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

ney a happy one. Discuss with the loan officer up front if the lock d

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

Following aspects would a

ys are enough to meet the closing target date. Many loans require an

dd to the challenges in developing combination products:

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

appraisal. This is a key area and can be a time consuming part of the

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

process. If the sales or refinance market is hot in your area it coul

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

d take longer than normal to complete the appraisal. Be sure and cove

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

estimated appraisal turnaround time with the loan officer during app

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

Professional from academic institutions, pharmaceutical industries, health care indust

lication.

During the loan process be sure and return any documentati

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

n quickly to the lender when asked. Be available to sign escrow paper

.

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

s in a timely manner. When the loan is funded, and you get the keys,

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

Companies that provide selfless information through particip

t’s a great feeling to know you closed your loan exactly as you hoped

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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