Useful Advices - Business

The process to go public via initial public offering (IPO) or Direct Public Offering (DPO) follows a prescribed path. While some elements can be handled simultaneously, there

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

are a number of parts that must be done sequentially. As a result, it will often take between six and nine months for a private company to go public.

We have highlighted the

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

Examples of combination products may in

major time elements to provide a basic understanding of the process.

1. The financial audit:
Completing the financial audits is perhaps the most time consuming part of t

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

he IPO process. The actual timeframe will largely depend on the current state of your financial books and records. If your firm is organized, has internally generated income s

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

tatements, balance sheets and statements of cash flow - with notations, you should be in pretty good shape. If your books and records are already prepared by a CPA, reviewed b

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

Combination pro

y an accounting firm or audited - that is best. Generally, it will take about 30 days for a start-up to be audited, while it can take 60-120+ days for a large operating busine

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

ss to be audited.

2. Preparation of the registration statement:
Preparing the registration statement to be filed with the SEC requires a complete review of all corporate

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

and financial books, records and documents. The better organized companies are able to provide all of the necessary documents upon request. The review itself can take a few d

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

ays to few weeks. Once complete, the registration statement can be drafted normally within two to eight weeks. Usually, the registration statement is done before the financial

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

audits. Once the financial audits are complete, they are integrated into the registration statement and filed with the SEC.

3. The SEC review process:
Once the registra

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

tion statement is filed with the Securities and Exchange Commission, the review and comment phase follows a certain path. Generally, the SEC will review the initial filings an

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

Following aspects would a

d will respond with comments in approximately 30 days. At that point, the company and its advisors are responsible for addressing each of the comments. This could take several

dd to the challenges in developing combination products:

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

hours to several days, depending on the nature of the comments. Once the response is completed, a revised registration statement is filed with the SEC. The review and comment

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

process continues until the SEC is satisfied. This normally takes between 60 days and 120 days, but could last materially longer - depending on the company and its advisors.

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

3. The stock exchange review process:
Each of the stock exchanges have a different review process. Generally, there are no stock exchange concerns if you satisfy all of

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

the SEC requirements. However, the stock exchanges will look at different factors, including the number of shareholders, amount of capital invested and the relationship betwee

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

Professional from academic institutions, pharmaceutical industries, health care indust

n and among all shareholders. One of their primary issues is to ensure that no individual or group controls the 'public-float'. The review and comment process with the stock e

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

xchange is similar to that of the SEC. It can last between two weeks and three months, depending on the company and its advisors.

If handled properly, it should take an avera

.

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

ge company between six and nine months to go public via an initial public offering (IPO) or direct public offering (DPO) - if it is coordinated and managed properly.

It is v

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

Companies that provide selfless information through particip

ery important to hire knowledgeable, experienced and qualified professional advisors to keep each of the parties involved in a going-public transaction on track and on budget.

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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Useful Advices - Going Public: How Long Does it Take?

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