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  • Answers - Helping Your Clients

    During the pre-qualifying interview, you learn that your client is holding a $125,000 note, secured by a commercial building that he sold along with his auto body
    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
    business. The note is earning a 10% interest rate payable over 30 years. Although the buyer came in with $50,000 cash, that amount only covered the purchase of t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e trade fixtures and the business. There was no equity applied toward the building purchase.

    Further, his business has been doing well and he has made timely pay
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ents ($1,097 per month) for three years now. Today, the remaining balance on the note is $122,690, or 98% Loan-to-Value (LTV). In testing the waters, you learn th
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    at $91,832 would be the approximate sales price for your client's note, a discount of $30,858!

    High Loan-to-Value

    However, because of the high LTV of 98%, the m
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    st your client will be able to sell his note for now is $81,250, which is an Investment-to-Value of 65% (ITV). That's an additional $10,600 discount, or a total l
    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 of $41,458. Whew!

    Your client does not like the sound of that. He only needs $55,000 for his business opportunity and he was counting on some of the monthly n
    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
    ote payments to help pay some of his daughter's college expenses.

    Your local note broker suggests a partial purchase arrangement. By selling half of each monthly
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    payment for the next 50 months, your client can get $20,000 cash today. That would leave him with a monthly note income of $547 to help with those college expense
    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
    . To get the remaining $35,000 your client needs, your local note broker would sell another 131 full payments, which the investor would begin to receive 50 months
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    from now.

    The Solution

    From an investor's standpoint, he put up $57,500 ($2,500 to cover the note broker's fee), representing only 46% ITV. Because of the equit
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    y cushion and payment history, he accepts a lower return than he would otherwise.

    By buying only a part of this note, the investor enjoys a 13% yield on a well-s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    cured 15-year investment. In working the numbers, you show that your client receives the $55,000 he needs right now, plus a $547 monthly income ($27,350 total) fo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the next 4.17 years, to cover his daughter's college years. He also holds an interest in the note, which will have a balance of $91,460 when he starts receiving
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the monthly payments again in 15 years.

    The three above figures represent $173,810 in cash benefits to your client. Even though your client fully understands the
    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
    time-value-of-money, the realization that he is receiving $48,810 more than he sold the building for (not counting the $39,490 in monthly payments he has already
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eceived) sure sounds a whole lot better than selling the note outright!

    No Additional Debt

    Another benefit is that your client has avoided taking on any additio
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nal debt obligations that would have occurred had he borrowed the money from the bank. In addition, he still has a large asset (the remaining interest in the note
    .

    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
    plus the partial monthly income) listed on his balance sheet. This leaves his financial statement much stronger should he have some long-term borrowing needs dow
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    the road.

    Your client achieves his objectives, you close a sale, and you have created the potential for more business -- both with your client and his referrals


    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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