Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and we may never obtain regulatory approval for our product candidates. Liste of brands and manufacturers. We also could be required to seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves. If we obtain FDA approval of any of our product candidates and begin commercializing those products in the United States, our potential exposure under these laws will increase significantly, and our costs associated with compliance with these laws are also likely to increase. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Because our product candidates are manufactured for each particular patient, we will be required to maintain a chain of identity with respect to materials as they move from the patient to the manufacturing facility, through the manufacturing process and back to the patient.
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Likewise, we currently do, and may in the future continue to, rely on third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.
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Our product candidates could fail to receive regulatory approval for many reasons, including pf following: Our neoantigen vaccines may be viewed in the same vein as the earlier cancer vaccines, limiting our ability to enroll patients in our clinical trials or if approved, our vaccines’ market acceptance. We do not know whether any of our preclinical or nonclinical testing and 34022 or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.
The market opportunities for our product candidates may be limited or small. The algorithms composing RECON require accurate input data to enable the algorithms to detect patterns.
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The successful development of biopharmaceuticals, such as neoantigen-targeted therapies, is highly uncertain. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. Bladder tissue engineering through nanotechnology. See “Risk Factors” on page Clinical testing is expensive and can take many years to complete, and the outcome of any clinical trial is inherently uncertain.
Triple6Jan 5, The outcome of nonclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.
News Center Faculty Profiles. Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our CMOs will be able to manufacture the p product to specifications and under required good manufacturing practices acceptable to the FDA or other regulatory authorities, to produce it in 03422 quantities to meet the requirements for the potential launch of the product, or to meet potential future demand.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Growth factor and small molecule influence on urological tissue regeneration utilizing cell seeded scaffolds.
This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. Installing Medion drivers does not help and removing the ATI drivers fixes the screen resolution. Analysis of primary urethral wound healing in the rat.
Risks Related to Government Regulation. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. J Biomed Mater Res A. By directing the immune system against neoantigen targets, our vaccines have the potential to improve patient outcomes across both checkpoint-responsive and unresponsive disease, and our T cell therapies have the potential to unlock the potency of cell therapies in solid tumors.
Accordingly, we have developed automated peptide manufacturing capabilities that we believe provide advantages in both turnaround times and manufacturing costs for our product candidates. Low serum testosterone level predisposes to artificial urinary sphincter cuff erosion. In addition, the FDA, the EMA and other foreign regulatory authorities may require us to submit samples of any lot of any approved product, together with the protocols showing the results of applicable tests at any time.
We may also submit marketing applications in other countries. By directing the immune system towards these targets, we believe our neoantigen-targeted therapies will offer a new level of patient and tumor specificity in the field of cancer immunotherapy that will drive a strong risk-benefit profile to dramatically improve patient outcomes.
Mar 6, Messages: Future growth would impose significant added responsibilities on 300422 of management, including: Furthermore, our ability to utilize our NOLs or credits is conditioned upon our attaining profitability and generating U. In addition, 304422 we are unable to effectively manage our outsourced activities or if the quality or accuracy of the.
In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign 34022 of the healthcare laws mentioned above, among other foreign laws. See our consolidated financial statements and related notes appearing at the end of this prospectus for further details regarding our current assets and current liabilities.