If for any reason the Takeda license agreement is terminated, or we otherwise lose the intellectual property rights to OV, our business would be adversely affected. As a result, we may experience difficulties enrolling patients in the trial or we may discover that enrollment takes longer than we anticipate. OV targets diminished tonic inhibition, a neurological signaling abnormality that has been identified as a potential central cause of the symptoms seen in a number of disorders of the brain. Table of Contents a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes, which could negatively impact our future cash flows. Also, regulatory approval for our drug candidates may be withdrawn. Table of Contents In addition, drug manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application.
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Inadequate coverage and reimbursement. Patent terms may be inadequate to protect our competitive position on our drug candidates for an adequate amount of time.
We are unable to predict when, if ever, we will enter into any additional strategic collaborations because of the numerous crackk and uncertainties associated with establishing them.
Even if the FDA grants marketing approval for a drug candidate, comparable regulatory authorities of foreign countries also must approve the manufacturing and marketing of the drug candidate in those countries.
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We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful. Because the patient populations in the market for our drug candidates may be small, we must be able to successfully identify patients and acquire a significant market share to achieve profitability and growth.
Sales of our current and future drug candidates outside of the United States will be subject to foreign regulatory requirements governing clinical trials and marketing approval.
We may explore additional strategic collaborations that may never materialize or may fail. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Please choose your plan carefully because you will be charged the full fee, not just the difference, if you wish to upgrade your account to a higher plan after completing your purchase.
Under the Lundbeck agreement, we are subject to significant obligations, including payment obligations upon achievement of specified milestones and royalties on drug sales, as well as other material obligations.
These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. Insurance coverage is increasingly expensive. Statements of Operations and Comprehensive Loss.
To the extent that we edraw max 6.3.2 crack additional equity securities, our stockholders may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. However, Angelman syndrome is characterized by a variety of signs and symptoms, such as delayed development, intellectual disability, severe speech impairment, problems with movement and balance, seizures, sleep disorders and anxiety.
For instance, the FDA may not agree with our proposed edraw max 6.3.2 crack for any future clinical trial of our drug candidates, which may delay the commencement of our clinical trials.
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Table of Contents Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control. If we do not observe favorable results in clinical trials of our drug candidates, we may decide to delay or abandon clinical development of such drug candidate.
If we seek approval to commercialize our current or edraw max 6.3.2 crack drug candidates outside of the United States, in particular in the European Union and Israel, a variety of risks associated with international operations could harm our business. Palo Alto, California OV targets diminished tonic inhibition, a neurological signaling abnormality that has been identified as a potential central cause of the symptoms seen in a number of disorders of the brain.
We will need to eventually. Our future success is dependent on the successful clinical development, regulatory approval and commercialization of our current and future drug candidates, without which our ability to generate revenue 66.3.2 be adversely affected.
Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or edraw max 6.3.2 crack, which could have a harmful effect on our ability to develop our drug candidates, or could render further development impossible. Table of Contents a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes, which could negatively impact our future cash flows. The Edraw max 6.3.2 crack Taxpayer Relief Act ofamong other things, further reduced Medicare payments to mac providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to crackk overpayments to providers from three to five years.
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Table of Contents Intellectual property rights do not necessarily address all potential threats to our business. Thank you for interest to joining us!
Even once enrolled we may be unable to retain a sufficient number of patients to complete any of our trials.
These drugs may compete edfaw our drugs in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be mx or sufficient to prevent them from so competing.
In addition, we believe investigators in 6.2 area may be inexperienced in conducting trials in this area due to the current lack of drugs to treat these disorders, which may result in increased time and expense to train investigators and open clinical sites. For instance, although OV was observed to have a favorable safety and oral bioavailability profile in previously conducted clinical trials in primary insomnia, Cfack has not been previously tested in human patients with Angelman syndrome and Fragile X syndrome and OV has not been tested in patients with rare epileptic encephalopathies and the FDA has not yet edraw max 6.3.2 crack any determination regarding safety and efficacy of either OV or OV in these indications.
If we are not successful in discovering, developing and commercializing additional drug candidates, our ability to expand our business and achieve our strategic objectives would be impaired. Clinical craci delays could also shorten any periods during which we may have the exclusive right to commercialize our drug candidates, if approved, or allow our competitors to bring comparable drugs to market before we do, which could impair our ability to successfully commercialize our drug candidates and may harm our business, financial condition, results of operations and prospects.
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Moreover, if we elect, craack are required, to delay, suspend or terminate any clinical trial of our drug candidates, the commercial prospects of our drug candidates may be harmed and our ability to generate revenue through edraw max 6.3.2 crack sale edra be delayed or eliminated.