FDA EPISODE 9501
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Cancer Res ; Raising additional capital may cause dilution to our stockholders, including purchasers of common stock in this offering, restrict our operations or require us to relinquish rights to our technologies or product candidates. Certain Relationships and Related Party Transactions. Ticagrelor competes against other commercially available antiplatelet therapies, including other P2Y 12 receptor antagonists, many of which are available as generic drugs and therefore significantly less expensive than ticagrelor. Because mitoxantrone has a lower cardiotoxic potential than doxorubicin, it may be advantageous to initially use mitoxantrone in the treatment of patients with indolent NHL, reserving doxorubicin for later use. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we may be unable to obtain regulatory approval of our marketing applications. If any of our product candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.
In fiscal the company acquired EQAL, a media company that creates and manages digital media properties for consumer brands and celebrities, including Jennifer Lopez, Bethenny Frankel, and Lauren Conrad. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. We have not obtained regulatory approval for any product candidate and it is possible that we may never obtain regulatory approval for PB, PB or any product candidates we may seek to develop in the future. Progress and promise in the treatment of indolent lymphomas. Treatment was well tolerated, with only two episodes of hospitalization for fever. Even if any of our product candidates receives marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
Interviewing Sample interview questions and expert advice. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. Wed, Jul 18 j2 Global, Inc.
Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials. Of these latter three, one included a randomized comparison of FM and CHOP followed by rituximab in selected patients in both arms [ 31 ]. Regardless of when filed, we may fail to identify relevant third party patents or patent applications, or we may incorrectly conclude that a third party patent is invalid or not infringed by our product candidates or activities.
We are currently conducting a Phase 2b clinical trial of PB and expect to report results from this trial in the first half of The FM regimen was generally well tolerated, with infrequent mild gastrointestinal toxicities being the predominant nonhematologic side effects. The market for PB, PB and any other product candidates may be smaller than we expect. The company also plans to continue acquiring similar businesses or technologies and to expand into international markets.
Although the results of the Italian multicenter study support the superiority of FM over CHOP in terms of clinical and molecular responses and tolerability, additional studies using rituximab in combination with both of these regimens should be attempted to determine the possible further benefit of both in the management of indolent lymphoma. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
She had an excellent response, remained in response for 20 months, and was able to maintain her current lifestyle during and after treatment. Because FM-based regimens use only 3 days of treatment with fludarabine, in contrast to 5 days with other fludarabine-containing regimens, FM may also be a preferable choice for patients who subsequently undergo autologous or allogeneic stem cell transplants.
The actions of our licensors may therefore affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under our license agreements.
The prominent Univision anchor said footage of his interview with the embattled Episoe president was confiscated. Work-up revealed 1—2 cm nodes in the inguinal area, but all laboratory data were otherwise unrevealing. Our net losses may fluctuate significantly from quarter to quarter and year to year. Articles by Zinzani, P.
We have not completed the development of any product candidates and we may never be able to develop marketable products. Although we control the prosecution, maintenance and enforcement of the licensed and sublicensed intellectual property relating to PB, we may require the cooperation of our licensor and any upstream licensors, which may not be forthcoming. Besides its activity as a single agent in the treatment of patients with follicular lymphomas, investigators have reported responses with mitoxantrone in combination with fludarabine, with or without dexamethasone, that appear better than those obtained with single-agent fludarabine in similar patient populations [ 523 ].
In contrast to the currently approved therapies for PAH, which only target vasodilation, we believe that VIP also suppresses the adverse remodeling of blood vessels and increases cardiac contractility and relaxation. When combined in vitro, fludarabine and mitoxantrone exert synergistic effects [ 22 ].
CB-EP – EtherNet/IP™ Unit | LS series | KEYENCE America
In this window In a new window. The clinical significance of molecular response in indolent follicular lymphomas.
Termination of our current or any future license agreements would reduce or eliminate our rights under these agreements and may result in our having to negotiate new spisode reinstated agreements with less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.
Furthermore, our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. The CHOP regimen subsequently became standard treatment for patients with aggressive lymphomas and is also eepisode used by clinicians to treat indolent lymphomas [ 5 ].
Our product candidates and any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities. Even if we are successful in continuing to build our pipeline, the potential product candidates that we identify, in-license or acquire may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance.
An adverse result in. Ann Oncol ; 4: To achieve commercial success for PB, PB and any other product candidate for which we may obtain marketing approval, we will episodde to establish a sales and marketing organization.
A decision by a third-party payor not to cover or separately reimburse for our products could reduce physician utilization of our products once approved. In that study, selected patients received rituximab following chemotherapy in both arms.
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. Therefore, we cannot be certain that the prosecution, maintenance and enforcement of these patent rights will be in a manner consistent with the best interests of our business.
The FDA or the applicable foreign regulatory agency also may approve or authorize for marketing a product candidate for a more limited indication or fdaa population that we originally request, and the FDA or applicable foreign regulatory agency may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization of a product candidate.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war.
Similarly, changes episove patent laws and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we may obtain in the future. For example, our loan and security epiode with Silicon Valley Bank, or SVB, is secured by a first priority security interest in substantially all of our current and future assets, excluding intellectual property.
If we uncover epiaode previously unknown risks related to our ELP technology, or if we experience unanticipated problems or delays in developing our ELP product candidates, we may be unable to complete our clinical trials and preclinical studies, meet the obligations of our license agreements or commercialize our product candidates on a timely or profitable basis.
Implications of Being an Emerging Growth Company. Neither we nor any future collaborator is permitted to market any drug product candidates in the United States until we receive regulatory approval of a BLA from the FDA.
Orphan drug exclusive marketing rights in the United States also may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. We will require additional capital to commercialize PB and PB To date, that trial provides the only direct comparative evidence supporting the addition of rituximab to mitoxantrone-based therapy for relapsed disease.
Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside eepisode the United States. However, no study has unequivocally demonstrated superior survival rates using the combination of rituximab and chemotherapy. If this Form is a post-effective amendment filed pursuant to Rule d under the Securities Act, check the following box and list the Securities Act registration number of the earlier fad registration statement for the same offering.
Possible consequences of Bcl-2 overexpression include increased longevity of malignant cells and resistance to many chemotherapeutic agents. Case interviews are a crucial part of the hiring process in the