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Had a good discussion with a few analysts (financial) and accounting on the quest

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

ion around differences between Restatement and Recertification of results - what

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

Examples of combination products may in

re they, what is the difference etc.?

1. Restatement: It will effectively rewite

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

a company's books. Dr. Min Wu of New York Univ of Business has a great paper on R

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

view of earnings restatement. Here are some highlights:

a) Restatements typicall

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

Combination pro

occur when a company, often in consultation with its auditors or the SEC, determ

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

nes that the company's financial statements contained either "errors" r

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

esulting from "mathematical mistakes, oversight, or misuse of facts at the t

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

me the financial statements were originally prepared," or "accounting i

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

regularities.” The dissertation focuses on these types of restatements. In

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

eality, it can be hard to distinguish between intentional misstatements and misin

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

Following aspects would a

erpreting the accounting rules.

b) There are several reasons for restatements. T

dd to the challenges in developing combination products:

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

e first involves companies that prematurely recognize revenues, or, even worse, r

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

cognize fictitious revenues. Misstating costs or expenses is one of the most comm

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

on ways of twisting current-year profits. Common techniques involve overstating i

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

ventory, overstating other long-term assets, underestimating or overestimating re

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

Professional from academic institutions, pharmaceutical industries, health care indust

erves, and shifting expenses from one period to another.

Restatement can involve

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

SEC-filed annual reports (10Ks), which are audited, and possibly the quarterly re

.

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

orts (10Qs). It can also involve only the interim quarters of the current fiscal

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

Companies that provide selfless information through particip

ear.

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

Nowadays thieves are looking for an easy plunder and have focused their eyes upon construction equipments too. Each year, construction equipment worth one billion dollar is stolen from the construction sites

Financial (sell side) analysts are a key constituent to ensuring your stock price does not take a big hit when you announce the backdating issue has hit your company. Here are the top 10 questions financial analysts have about options backdating and what you need to do to help ensure communication is correct, accurate and positive.

This is the perfect topic for the first month of a brand new year! Staying late started innocently enough: “If I just stay a little later today, I can catch up’ on this work I haven’t been able to g...

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Digg It - Options Backdating: Restatement: Meaning, Types, Impact

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