Advice You - Finance

There are TWO things you should find out from the attorney (or ask the debtor in the client intake interview) before you start drafti

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

ng a bankruptcy petition. These two questions are:

1. Have you completed the credit counseling requirement?
2. Have you ever

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

Examples of combination products may in

filed bankruptcy? If so – when?

As a virtual bankruptcy assistant working for bankruptcy attorneys, we have encountered several pr

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

blems when not asking these questions before drafting the petition. After the attorney has the client fill out the Client Intake Form

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

s and sends them to us, we assume the attorney has already qualified these debtors. But as amazing as it sounds – we have spent many

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

Combination pro

ours inputting information into the bankruptcy petition only to find out the client has not completed the credit counseling requireme

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

nt.

At this stage we have no choice but to immediately stop drafting the bankruptcy petition and notify the attorney at once. Unles

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 debtor can go online and obtain his or her credit counseling certificate within a few days, the figures we entered into the bank

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

ruptcy software will need to be changed. Therefore, we will stop the process. Then, when the client obtains the credit counseling cer

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

ificate, we will go back and update the Means Test as well as any additional income information on Schedules I and J and year-to-date

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

totals under Item #1 or #2 of the Statement of Affairs.

But if you want to eliminate the possibility of this situation occurring al

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

Following aspects would a

together, do not input a bankruptcy petition until you have verified the debtor has completed the credit counseling requirement. This

dd to the challenges in developing combination products:

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

information should be provided by the attorney you are working for or a member of the law staff. But in our experience, we obtained t

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

his information from the debtor during the client intake interview.

The same thing holds true regarding prior bankruptcy filings. If

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

you discover a debtor has filed bankruptcy within the past 2 years, you will want to use the information below to determine if the de

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

btor's are eligible to file.

Under the new bankruptcy law:

1. If someone files a Chapter 7, they cannot file another Chapter 7 for

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

Professional from academic institutions, pharmaceutical industries, health care indust

8 years.

2. If someone files a Chapter 7, they cannot file a Chapter 13 for 4 years.

3. If someone files a Chapter 13, they canno

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

t file a Chapter 7 for 6 years.

4. If someone files a Chapter 13, they cannot file another Chapter 13 for 2 years.

Completing this

.

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

step before drafting the bankruptcy petition will save you, your attorney and the law firm a great deal of time and expense.

To rece

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

Companies that provide selfless information through particip

ive more bankruptcy petition drafting tips subscribe to the free Bankruptcy Training News at http://www.713training.com/subscribe.htm

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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