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One of the biggest misconceptions about filing for bankruptcy in Edmonton, Alberta, or anywhere in Canada, i

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

s that personal bankruptcy will eliminate your ability to borrow money in the future. This simply isn't true.

The only restriction on borrowi

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

Examples of combination products may in

ng money is that while you are in bankruptcy (i.e. prior to receiving a discharge) you are not allowed to borrow more than $500 without inform

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

ing the lender that you are in the middle of a bankruptcy. Once you are discharged from bankruptcy this requirement is removed. Now let's talk

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

logistics.

Is every lender required to loan you money?

Of course not. No lender is ever obligated to loan anyone money, but as we a

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

Combination pro

ll know, money is lent every day and often the situations are much riskier than those if a newly discharged bankrupt. You have to remember tha

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

t the decision to lend money is based on a number of things including your credit history, your income, the stability of your income, the asse

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

ts you own, the debt you carry and how much money you have available after you have paid all you monthly living costs.

The only item that is

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

egatively affected by filing a bankruptcy is your credit history. In fact, as a result of filing bankruptcy some of the items conside

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

red now appear more positive, as your debt load should be almost eliminated, resulting in significantly more cash flow each month. So ultimate

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

ly, the end result of filing a bankruptcy is that you are in a much less risky position than if you had not filed a bankruptcy
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
>.

Does this mean getting a loan after bankruptcy will be easy?

No, but we find that with a little work it is much easier than exp
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
cted. After being discharged from bankruptcy your challenge will be to demonstrate to the bank that:

a) you are not in a risky position; and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

b) you have learned from the experience.

How you address these issues will depend largely on your personal situation, but it never hurts to
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
start with a frank discussion of the challenge you face in rebuilding your credit and the reasons why you are in the situation you are. This w
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
ill enable you to discuss the bankruptcy, the issues that led up to the bankruptcy, and what you have done to prevent these issues from causin
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
you difficulties in the future.

For further information about bankruptcy in Edm
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
onton or anywhere else in Canada I suggest you contact a licensed bankruptcy trustee. Remember, each situation is unique, and as a result
.

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
each situation requires an individually tailored strategy. With the help of a trustee you will be to develop a plan that will allow you to dea
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
l with your existing debt, develop strategies to prevent future difficulties, eliminate the unnecessary stress and get your life back on track

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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