MD 30422 PV DRIVER

If we are unable to confirm or replicate the results from investigator-sponsored trials or if those trials produce negative results, we would likely be further delayed or prevented from advancing further clinical development of our product candidates. However, we would not have control over the timing and reporting of the data from investigator-sponsored trials, nor would we own the data from the investigator-sponsored trials. Preclinical development is uncertain. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and bone marrow transplantation, rather than enroll patients in a clinical trial. For example, earlier cancer vaccines attempted to direct the immune system against a class of molecules found predominantly, but not exclusively, at the tumor site.

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Coverage 3022 reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor's determination that use of a product is: Because we have limited financial and human resources, we intend to initially focus on research programs and product candidates for a limited set of indications. We are pleased to welcome you as a new customer.

If so, the FDA or other non-U. Smaller or early-stage companies may also prove to be 300422 competitors, particularly through collaborative arrangements with large, established companies.

Treiber & Updates

Even minor deviations from normal manufacturing processes could result in reduced production yields, lot failures, product defects, product recalls, product liability claims and other supply disruptions.

We own various U. Our research and development activities involve the use of biological and hazardous materials and produce hazardous waste products. We expect to continue to spend substantial amounts to conduct further research and development and preclinical or nonclinical testing and studies and clinical trials of our current and future programs, to seek regulatory approvals for our product candidates and to launch and commercialize any products for which we receive regulatory approval, including potentially building our own commercial organization.

Publications

A BLA must include extensive nonclinical and clinical data and supporting information to establish that the product candidate is safe, pure and potent for each desired indication. These delays could also prevent completion of these trials and adversely affect our ability to advance the development of our product candidates. The number of potential patients for our product candidates may turn out to be lower than expected.

This manual contains a separate chapter on the subject of service beginning on page We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.

Meanwhile, NEO-PTC involves the activation and expansion of neoantigen-specific T cells ex vivoan approach that may be less effective than anticipated. Obtaining and maintaining regulatory approval of a product candidate in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval for that product candidate in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others.

Investing in our common stock involves a high degree of risk. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or 304222 any sale of the common stock. Genetic mutations, which are a hallmark of cancer, can result in specific immune targets called neoantigens.

Mar 6, Messages: We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates. J Biomed Mater Res A. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

The ov of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially. This preliminary prospectus is not an offer to sell these securities nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

If our competitors develop bioinformatics and engage in the computation and analysis of complex algorithms to identify neoantigen targets and develop associated therapies, our ability to develop and market a promising product or product candidate may diminish substantially, which could have a material adverse effect on our business, financial condition, prospects and results of operations.

Competition may increase further due to advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

Even if we obtain significant market share for our product candidates, if the potential target populations are small, we may never achieve profitability without obtaining regulatory approval for additional indications. No, create an account now. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates post-approval could have a material adverse effect on our business, financial condition, prospects and results of operations.

Moreover, while we are not aware of any specific genetic or biomarker diagnostic tests for which regulatory approval would be necessary in order to advance any of our product candidates to clinical trials or potential commercialization, in the future, regulatory agencies may require the development and approval of these types of tests.

Intel i7 MB: If any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

After the completion of this offering, future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern.