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If you look at all the press releases from various companies on the options backdating issue and start to detect patterns, you cannot but

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

help think they are written all by the same legal firm - they have the same boiler plate stuff, bunch of nonsense, a few technical terms

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

Examples of combination products may in

and a few buzzwords. So we are attempting to clear up the mess with plain-speak.

1. What they say - " The SEC has issued an informa

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

inquiry against our options backdating practices".

What they mean - " Damm! the SEC is a pretty rough bunch. Their informal i

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

quiry looks more like a indicitment. We are not exactly sure what all we did wrong and not sure of what all we have to do to correct it.

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

Combination pro

n any event, if we say its informal then the stockholders will think its nothing big."

2. What they say - " We intend to fully

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

cooperate with the SEC" What they mean - "What choice do we have? Its not as if we have a whole bunch of options. Its like your

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

ex-wife asking you to talk to her through the divorce settlement. If we dont cooperate we will all go to jail. We have to cooperate else

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

e'll look guilty. If we do cooperate we will only end up paying a bunch of lawyers fines and settlement fees."

3. What they say - &

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

uot;There were material weaknesses in our internal controls" What they mean - " No one was minding the shop really. We were all

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

busy getting drunk on "eyeballs", "business development deals" and "barney relationships". The accountants

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

Following aspects would a

and lawyers were there too. They actually helped us through this. When someone from the audit team asked, we would either transfer them o

dd to the challenges in developing combination products:

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

ask them to leave. Now we have a mess. This SOX thing has also put some pressure on us. If we admit we had internal controls problems bu

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

now we passed our SOX audit, then we will absolve ourselves of all blame."

4. What they say - "Senior executives in the compa

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

y who have been associated with this have resigned" What they mean - " Its not us its them. We are the nice guys. If there was

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

nything going on it was under their watch. Sue them and leave us alone"

5. What they say - "Our board and audit teams have alr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ady started an internal investigation of our options backdating and will report their results soon" What they mean - " Our boar

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

got really scared they might get implicated in this. Finally after all these years they actually have to do some work to earn their pay

.

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

nstead of coming to our meetings, eating donuts, asking for gourmet coffee and paying golf with the CEO. So they came together, asked us

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

Companies that provide selfless information through particip

o spend a bunch of money so they could CTA (Cover their AS*)

http://blog.vangal.com

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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Digg It - What PR Organizations Say, What They Mean About Options Backdating

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