Just Answers - Finance

Its dinnertime and the phone rings. It's Joe Noname with SuchNSuch Investment Company and has he got a deal for you.

Joe wants to be friendly and engage you in a few

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

not-too-personal questions just to break the ice before he gets into his too-good-too-be-true pitch. Stock, oil, Internet, telecommunications, you name it.

Joe tells

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

Examples of combination products may in

ou about his company's credentials and how they are "affiliated" with some big New York bank or investment house - a name that everyone knows and trusts. And Joe also

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

wants you to know how experienced he is and he came from a big, well-known brokerage house because this deal was too good to pass up and he wanted everyone to know abo

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

t it. He has even bought shares in it himself. And pigs can fly!

He carefully mixes truth with unsubstantiated material, which appears to be fact. His company is regi

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

Combination pro

stered (probably true) and approved by the Securities and Exchange Commission (lie, they don't approve of any company) and is affiliated with AT&T or Bill Gates (a lie

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

but very hard to check out). He interweaves little lies and big ones so it all sounds credible.

This investment is so good it is underwritten by the big brokerage ho

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

use Morgan Stanley and guaranteed by MCI or some other big name. Furthermore, we guarantee your investment because you are paid first before any dividends are paid to

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

ny other shareholder. This is a "no-risk" investment. The last time our company had one of the high quality investments all the investors made 500% on their money in l

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

ess than 18 months. Isn't that great! I wish I had some of the first offering; I'd be rich now. Joe will probably quote you some stock offering like Yahoo or Intel tha

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

did make this kind of return or even more, but you can be assured this company had nothing to do with it.

"Mr. Mushroom, don't miss out on this as there are only a l

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

Following aspects would a

imited number of shares my company is allowing me to offer. How much cash do you have you would like to make 500% on at this time? $5,000. I'll tell you what I'll do,

dd to the challenges in developing combination products:

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

'll reserve a thousand shares for you and give you the option to pick up another 10,000 shares any time in the next 30 days provided you can wire in the first $5,000 i

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

mmediately." Be careful of any offer where they must have the cash now, immediately, before yesterday. Or Joe is going to send you papers via FedX and you must return

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

hem immediately. And always kiss your money goodbye before you send it because that is the last time you will ever see it.

Ask for their address. If it is a P.O. box

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

you know it is a scam. Whatever he tells you make sure it is not one of those mailbox businesses. Joe is either in a boiler room or calling you from home. Get his offi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e phone number and home number. Ask him where he got your name.

In a nutshell here is what you want to listen for: The return is illogical (too good), his credentials

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

are uncheckable, the names he drops are almost impossible to verify, it is a "no-risk" deal, they won't give you time to check them out (FedX) and you really don't kn

.

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

w where they are located.

When Joe Noname calls I am polite and firm and just, very quickly, even before he gets into his pitch, say, "Thanks for the call, Joe, but I

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

Companies that provide selfless information through particip

'm not interested" and I immediately hang up. Joe prefers this also because now he can go on to the next sucker.

Please, don't ever send money to a voice on the phone

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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