Answers - Finance

Just the other day we were talking about getting "blindsided". We were in a stock that came out of the blue with an e

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

arnings shortfall warning. That stunk. Then there is a blindside of another type, like when some nuts blew up several

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

Examples of combination products may in

subway areas of London. The world markets fell in a heap, and heading into the open, the futures were off fairly subs

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

tantially.

The question on a day like that is, what do you do? The answer of course is "nothing". You weather the st

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

rm and sit tight. Why? Because the market is an odd place.

The financial markets almost disgust me. In fact, they do

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

Combination pro

disgust me. We are talking about money here, and nowhere in the world is the concept of greed more evident than in W

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

ll Street. For someone like me who is oft quoted as saying money isn't everything, it seems odd that I'd be involved

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

in the business of it. But that's indeed where I am, and sometimes it disgusts me.

Why? Because when something like

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

his happens, the market goes into calculation mode. They look at the airlines, the drop in travel, the overall fear f

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

actors and then calculate where to make their money. In a situation like the London bombing, the first reaction is a

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

nee jerk sell off. But then the calculations get made, and in a matter of days, things are quite close to where they

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

Following aspects would a

were before the event. It's the ultimate example of "reverting to the mean".

So, in a situation like this, where the

dd to the challenges in developing combination products:

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

e didn't seem to be any biological, or nuclear events, they instantly decided that the markets had become a bargain a

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

nd they moved in. Cautiously of course, but they bought none the less. Sitting tight during most of these sorts of ev

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

nts is indeed the only thing to do. Panicking out will just lose you money.

What about the stocks you have? First, r

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

emove ALL stops the minute you get up. When the market is looking to fall hard on an "event" you'll get stopped out a

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

Professional from academic institutions, pharmaceutical industries, health care indust

most immediately, but at a horrid price. Remove your stops and then make an assessment of the panic. If it's not some

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

thing that's going to really bother the market, then sit out the day. If it looks like it could be "really" serious,

.

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

ell the first decent bounce, and wait to re enter lower.

Terror stinks but it's what we have today. The market's rea

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

Companies that provide selfless information through particip

ct, just don't let them get you panicked. Go slow, and use your head. Often times, you'll end up in pretty good shape

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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