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Sie haben zu viele Anfragen gesendet, sodass Linguee Ihren Computer ausgesperrt hat.Exact name of registrant as specified in its charter. Maryland State or other jurisdiction of incorporation or organization. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or leggit alpha pharma verification code legit reporting company. Do not check if a smaller reporting company. Documents Incorporated by Reference:
Osiris Therapeutics, Inc. (OSIR)
Exact name of registrant as specified in its charter. Maryland State or other jurisdiction of incorporation or organization. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
Do not check if a smaller reporting company. Documents Incorporated by Reference: The scope of the Independent Review, which was determined by the Audit Committee after discussion with BDO and outside professionals engaged by the Audit Committee, focused primarily on revenue recognition related to distributor sales arrangements. In reaching these conclusions, the Audit Committee considered information derived from the Independent Review, as well as procedures and other work performed by management.
The evidence suggests that an arrangement with the distributor did not exist in so that the criteria required under GAAP to recognize revenue for this transaction in was not met. In the Restatement, the Company will reverse revenue previously recorded in for these sales transactions with the three distributors and will thereafter recognize revenue from these transactions under the cash, rather than accrual, basis of accounting, which means that revenue arising from these transactions will be recognized in subsequent periods upon receipt of payment from the customer.
Certain other adjustments identified by management, including correction of errors in the valuation of inventory, accounting for consigned inventory quantities, determination of bad debt reserve and the classification of costs and expenses, were made to the financial statements in connection with the Restatement.
The Audit Committee, at the request of management and as part of the Independent Review, also evaluated certain issues related to director expense reimbursements. Description of the Restatement. Recognition of revenue under distributor sales arrangements. Based on the Independent Review, the Company determined that it had erred in its application of GAAP with respect to the recognition of revenue arising from certain distributor sales arrangements as described below:.
Certain distributor sales did not meet the criteria for recognizing revenue in During , the Company provided unusually long payment terms to two distributors that were affiliated with each other. Also, for one sales transaction to a third distributor in the fourth quarter of , the Company determined that evidence existed which suggests that an arrangement under GAAP did not exist in Accordingly, revenue arising from these transactions did not meet the criteria for recognizing revenue under GAAP in Sales through government contracting agent.
Similarly, sales commission expenses incurred during in connection with the distributor sales transactions for which revenue has been reversed have also been reversed. Valuation of inventory and accounting for consigned inventory quantities.
In addition, management determined the need to establish a reserve for consigned finished goods inventory as the Company had not adequately monitored the ultimate disposition of consigned goods whereby some were returned, or scrapped, or used by the consignee.
This process results in a reasonably consistent identification of product that is unsalable. Classification of costs and expenses to income statement captions. Management determined that errors had been made in classification of costs and expenses to income statement captions. In addition to the errors mentioned above, adjustments were made to the financial statements for various other errors identified by management and the Audit Committee during the course of the restatement process.
Tax effect of Restatement adjustments. GAAP requires the recognition of revenue when the customer payment is received if unusually long payment terms are offered.
Revision of Prior Period Financial Statements. Cost of product revenue. Sales and marketing expenses. Fees paid to related parties. Tax Effect of the Adjustments. Income from discontinued operations. The Company has implemented and continues to implement measures to remediate these material weaknesses. Financial Statements and Supplementary Data.
Exhibits, Financial Statement Schedules. Statements included or incorporated herein which are not historical facts are forward looking statements. While management believes that its assumptions are reasonable, forward-looking statements are subject to various known and unknown risks and uncertainties and actual results may differ materially from those expressed or implied herein.
Examples of forward-looking statements may include, without limitation, statements regarding any of the following: Except as otherwise required by law, we undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances and do not intend to do so. We are subject to numerous risks and uncertainties in the course of our business. In addition to the other information contained in this report and the exhibits hereto, you should carefully consider the risks and uncertainties described below as.
These risks are not the only ones that we may face. Additional risks not presently known to us or that we currently consider immaterial may also impair our business operations.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks faced by us described below or elsewhere in this report. Risks Related To Our Business. We have a history of operating losses and may not achieve or sustain profitability. Until fiscal , we incurred losses in each year since our inception, and may incur additional losses in the future. We expect to continue to incur significant operating expenses in the foreseeable future as we seek to: The extent of our future operating losses or profits is highly uncertain, and we may not achieve or sustain profitability.
If we are unable to achieve and then maintain profitability, the market value of our common stock will decline and you could lose part or all of your investment. The current credit and financial market conditions may exacerbate certain risks affecting our business. We rely upon third parties for certain aspects of our business, including collaboration partners, wholesale distributors, contract clinical trial providers, contract manufacturers and third-party suppliers.
Because of the tightened global credit and continuing volatility in the financial markets, there may be a delay or disruption in the performance or satisfaction of commitments to us by these third parties, which could adversely affect our business.
We depend on key personnel. Our future success depends to a significant extent on the skills, experience and efforts of our scientific, management, and sales personnel. None of our employees is employed for a specified term. Competition for personnel is intense. We may be unable to retain our current personnel or attract or integrate other qualified management and scientific personnel in the future which could harm our business and might significantly delay or prevent the achievement of research, development or business objectives.
The potential of our Biosurgery products and products under development to treat conditions may not be realized. We are continually evaluating the potential of our Biosurgery products and products under development. Our products are susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate efficacy or other characteristics that may prevent or limit their commercial use, or if required, marketing approval.
If the treatment potential of our products is not realized, the value of our technology, our development programs and our products could be significantly reduced. Because our Biosurgery products are comprised of human tissue, any negative developments regarding the therapeutic potential or side effects of human tissue products could have a material adverse effect on our business, financial condition and results of operations. Our product development programs are based on novel technologies and are inherently risky.
We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our products and product candidates creates significant challenges in regards to product development and optimization, processing and manufacturing, government regulation, third-party reimbursement and market acceptance. For example, questions persist with regard to the necessity of FDA approval for some cell-based products, and therefore, the pathway to commercialization of our Biosurgery products may be more complex and lengthy.
Additionally, cell-based products are subject to donor-to-donor variability, which can make standardization more difficult. As a result, the development and commercialization pathway for our products may be subject to increased uncertainty, as compared to the pathway for conventional products. Our Biosurgery products represent new classes of therapy that the marketplace may not understand or accept. The market may not understand or accept our products.
We are developing products that represent novel treatments or therapies and which will compete with a number of more conventional products and therapies manufactured and marketed by others, including major pharmaceutical companies. The novel nature of our Biosurgery products creates significant challenges in regards to product development and optimization, manufacturing, government regulation and third-party reimbursement. As a result, the development pathway for our Biosurgery products may be subject to increased scrutiny, as compared to the pathway for more conventional products.
The degree of market acceptance of any of our developed or potential products will depend on a number of factors, including: If the health care community does not accept our potential products for any of the foregoing reasons, or for any other reason, it could affect our sales, which could have a material adverse effect on our business, financial condition and results of operations. The successful commercialization and distribution of our Biosurgery products will depend on obtaining reimbursement from third-party payors.
We distribute our Biosurgery products in the United States. We may expand our distribution to other countries in the future. In the United States and elsewhere, the market for any pharmaceutical or therapeutic product is affected by the availability of reimbursement from third-party payors, such as government health administration authorities, private health insurers, health maintenance organizations and pharmacy benefit management companies.
This, in turn, may make it more difficult for our customers to obtain adequate reimbursement from third-party payors for our products and the procedures in which they are used, particularly if we cannot demonstrate a favorable cost-benefit relationship. Third-party payors may also deny coverage if they determine that the product has not received appropriate clearances from the FDA or other government regulators or is experimental, unnecessary or inappropriate.
In the countries of Europe and in some other countries, the pricing of prescription and therapeutic products and services, and reimbursement, are subject to increased governmental control.
In addition, many other countries require pre-marketing approval for human tissue-based products, or otherwise more extensively regulate human tissue-based products than does the United States. Regardless of whether we are required to conduct a successful clinical trial in order to market a product in the United States or a foreign country, we may nevertheless be required to conduct one or more clinical trials, and to publish one or more peer reviewed journal articles supporting the product, before we are able to obtain third-party reimbursement.
We may also be required to conduct additional clinical trials that compare the cost effectiveness of our products to other available therapies before third-party payors will provide reimbursement. Conducting clinical trials is expensive and will result in delays in wide scale commercialization and reimbursement.
Publishing of peer reviewed journal articles may also be costly and result in delays. In addition, even if our products otherwise meet the requirements for reimbursement, pricing negotiations with third-party payors may take months and result in significant delay in obtaining approval for reimbursement. Reimbursement policies also sometimes differ depending upon the setting in which the product is to be used.
The use of our Biosurgery products in a hospital setting as part of a surgical or other more extensive procedure may have a reimbursement pathway that differs from a use in an outpatient setting for a more narrowly defined procedure.
These differences may limit or make reimbursement more difficult for some products as compared to others, and influence our product development and marketing efforts in ways that may ultimately prove to be detrimental to us or our business. Managing and reducing health care costs has been a general concern of federal and state governments in the United States and of foreign governments. Although we do not believe that any recently enacted or presently proposed U.
In addition, third-party payors are increasingly challenging the price and cost-effectiveness of medical products and services, and many limit reimbursement for newly approved health care products. In particular, third-party payors may limit the indications for which they will reimburse patients who use any products that we may develop, or they may not provide reimbursement for our products separately from the procedures in which they are used to encourage providers to select products based on cost-effectiveness.
Cost-control initiatives could decrease the price for products that we may develop, which would result in lower product revenue to us.
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