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Larry, Moe and Curley were sitting in their favorite restaurant just off Wall Street having their usual 3 martini lunch and were disc

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

ussing the day’s events and their client portfolios.

Larry:”I had 12 calls this morning from customers wanting to know why the mark

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

Examples of combination products may in

et was going down”.

Moe: What did you tell them?”

Curley: “Yeah, what”, taking another gulp of his libation.

Larry: “You know, the us

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

ual. This is a normal correction and not to worry. I am watching your account. The market always comes back.”

Moe: ”That’s the same

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

BS I tell them.”

Curley: “ I have more than 300 accounts and I can’t watch them except my 5 big traders. Who cares about the others

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

Combination pro

anyway? My company won’t let me tell them to sell when their stock starts down and they believe the old saw about ‘hang in there for

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

the long haul’. I blew out of all my stocks last week. Thank goodness. The market has dropped 300 points since then.

Moe: “It would b

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

better for the customers if our company would let us tell them to use stop loss orders."

Larry and Moe, shouting in a single voice

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

: “Don’t say that or we’ll get fired”. They both bonk him on the head spilling his drink. “Nyuk. Nyuk.”

Yes, it may sound funny, but t

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

here is more truth than fiction in that imaginary conversation.

Why don’t brokerage companies tell their customers to sell when the

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

market is declining?

There are two reasons. First any large brokerage does not want to get on the bad side of a company. That compa

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

Following aspects would a

ny might have a public offering later on and they will definitely not be asked to sell any of the stock or bonds. This is where the bi

dd to the challenges in developing combination products:

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

g money is on Wall Street. The second reason is they don’t want the customer to have cash in his account. He might take it out.

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

Brokers make money even if you do not trade. It is not much, but it does keep the pilot light lit.

Brokers also discourage customer s

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

op loss orders because it is more paper work for them and then they do have to watch your account. Unless your account is high 6-figur

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

e or 7-figure you are not on the radar screen. Mr. Broker (an appropriate name for what he does with your money) has an average of 300

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

Professional from academic institutions, pharmaceutical industries, health care indust

accounts and many have 600 or 700. As new guys come into their office they give them the little accounts.

When a broker passes his se

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

curities license he is given two manuals. One is SEC regulations that must be followed and the second is how to open accounts. There i

.

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 no third manual on how to protect customers’ money or trade. Brokerage companies want their salesmen to follow the company line and

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

Companies that provide selfless information through particip

push certain products. There is no thought of customer protection.

If your broker is Larry, Moe or Curley it is time to find a new one

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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