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At the Australian Small Scale Offerings Board web site ww

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

w.assob.com.au you will find opportunities to invest in exciting smaller g

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

Examples of combination products may in

rowth enterprises that are, or propose to become, unlisted Public Companie

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

s. Many have staged their capital raising to show notional share price in

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

creases of 50% or more in Round 2 or 3 of their capital raising. These st

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

Combination pro

rategies take away the traditional reliance on “patient” capital, giving i

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

nvestors the potential to crystallize a profit much quicker, rather than

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

having to wait until a Company produces dividends – which may not occur fo

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

r two, three or five years or more.

The primary focus of the Australian S

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

mall Scale Offerings Board is to enable small to medium sized enterprises

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

(SME’s) to explore the potential to attract investment capital into their

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

Following aspects would a

enterprise through a small scale offering of debt or equity securities. T

dd to the challenges in developing combination products:

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

hrough the Australian Small Scale Offerings Board we provide a platform wh

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

ere buyers and sellers of ownerships parcels of SME’s know what to expect

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

and what is expected of them.

The independant accredited members of the A

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

ustralian Small Scale Offerings Board provide their client SME’s with two

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

Professional from academic institutions, pharmaceutical industries, health care indust

main things – the legal exemption to sell securities and the appropriate f

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

ramework for doing so without breaching the Corporations Act 2001.

To inv

.

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

estigate this topic further kindly go to:elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

.assob.com.au/raising_capital.asp">www.assob.com.au/raising_capital.asp

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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Well the Australian Government is allowing the Franchise Attorneys in their country to ruin the franchise model and so are the Canadians too. Australian Franchise Law is affecting their Economy, as Australia does not export enough and needs to export more.

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