Sentences with phrase «of timely trials»

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

First - degree relatives of individuals with MS are at a higher risk of developing MS, 47 and a prevention trial among this population would be possible and timely.

Adapted by Don M. Mankiewicz from his own novel, Trial is a surprisingly timely story of how justice can sometimes be compromised by «special interests».

But they're both as timely today as the day they were published, offering a reminder of how much things stay the same — and frequently offering more insight into today's trials and tribulations than most of our ephemeral, overheated daily coverage and commentary.

[5] Especially for products that are constantly evolving, such as textbooks and educational software, such an approach would provide more timely evidence than randomized clinical trials, at a fraction of the cost.

[v] Especially for products that are constantly evolving, such as textbooks and educational software, such an approach would provide more timely evidence than randomized clinical trials, at a fraction of the cost.

For instance, homeowners Odalid and Wilfredo Bosque, according to one suit, entered the trial period from October to December of last year, but after they «timely made each of the payments,» Wells Fargo did not offer a final agreement.

This is probably the most timely show opening this week, in the shadow of police officer William Porter's high - profile trial for his part in the death of Freddie Gray, who had been illegally arrested by Porter's fellow officers.

At trial, Plaintiff claimed that the doctor was negligent in failing to order a loading dose of magnesium sulfate to prevent eclamptic seizures, and that he failed to perform a perimortem Cesarean section delivery in a timely fashion.

In a ruling written by justices Michael Moldaver, Andromache Karakatsanis, and Russell Brown, on behalf of a unanimous nine - judge panel, the court sides with the defendant in ruling that his constitutional right to a reasonably timely trial had been violated.

The trial court granted the motion, and the Court of Appeals affirmed, holding that neither the discovery rule nor Trial Rule 15 (C) rendered Bradshaw's amended complaint titrial court granted the motion, and the Court of Appeals affirmed, holding that neither the discovery rule nor Trial Rule 15 (C) rendered Bradshaw's amended complaint tiTrial Rule 15 (C) rendered Bradshaw's amended complaint timely.

This case is worth a quick read as it is a great example of an LVI claim going to trial, having all the evidence heard in two days, and receiving timely reasons for judgement.

What this means is that, where issues can be decided and narrowed without a full trial, parties can use summary judgment motions to expedite the resolution of lawsuits, allowing for access to justice in a timely manner.

However, LAWPRO counsel persuaded the court that under s. 37 (1)(2) of the Construction Lien Act, these liens were entitled to «shelter» under the lien action commenced and set down for trial by the general contractor in a timely way.

Lurid show - trial of a vulnerable man, the timely vindication of justice being done, and being seen to be done, a CPS volte - face.

The trial judge found that the incidents complained of took place outside the workplace, the employee had made a timely apology to the victim which he had accepted and several of the incidents alleged to have amounted to sexual harassment and breach of the employment contract in fact was found to be «consensual conduct among friends».

Our client's objectives drive our strategy, whether the objective is immediate injunctive relief, timely resolution of a business dispute, private arbitration, or victory at trial or on appeal.

This can mean employing bad faith tactics such as frivolous motions to drive up the cost of litigation, failing to comply with orders in a timely manner and, if the party is the defendant, deliberately attempting to delay the action from proceeding to trial.

McLachlin's remarks are timely given the Shafia «honour - killing» trial that ended in Kingston over the weekend with convictions and life sentences handed down against a man and his parents in the first - degree murder of four family members.

â $ cents Minimum 5 years of Litigation experience â $ cents Confident and dependable, with strong initiative and ability to work both independently and in a team oriented atmosphere â $ cents Organize and maintain client files â $ cents Experience liasing with clients, insurance adjusters and defence counsel â $ cents Prepare and edit correspondence and legal documents â $ cents Assist with authorizations, undertakings, discoveries and productions â $ cents Drafting pleadings, routine motions, affidavits of documents, pre - trial / mediation memos, etc. â $ cents Reviewing and summarizing medical documentation â $ cents Trial preparation â $ cents Responsible for tracking limitation periods â $ cents Prior experience working with Ontario & Superior Court of Justice â $ cents Draft and respond to correspondence â $ cents Initiate follow - up as required and communicate with clients â $ cents Calendar management, scheduling meetings and arrange examinations for discovery and mediations â $ cents Coordinate and monitor administrative functions to ensure completion of work accurately and in a timely manner â $ cents Act as liaison between clients and lawyers â $ cents Other duties as reqtrial / mediation memos, etc. â $ cents Reviewing and summarizing medical documentation â $ cents Trial preparation â $ cents Responsible for tracking limitation periods â $ cents Prior experience working with Ontario & Superior Court of Justice â $ cents Draft and respond to correspondence â $ cents Initiate follow - up as required and communicate with clients â $ cents Calendar management, scheduling meetings and arrange examinations for discovery and mediations â $ cents Coordinate and monitor administrative functions to ensure completion of work accurately and in a timely manner â $ cents Act as liaison between clients and lawyers â $ cents Other duties as reqTrial preparation â $ cents Responsible for tracking limitation periods â $ cents Prior experience working with Ontario & Superior Court of Justice â $ cents Draft and respond to correspondence â $ cents Initiate follow - up as required and communicate with clients â $ cents Calendar management, scheduling meetings and arrange examinations for discovery and mediations â $ cents Coordinate and monitor administrative functions to ensure completion of work accurately and in a timely manner â $ cents Act as liaison between clients and lawyers â $ cents Other duties as required

Because in B.C. family law value of property is based on the fair market value at date of trial or date of the actual agreement, there is a risk for those who don't resolve the issues in a timely matter that the values will fluctuate.

It is very much the role of the court and the clients to promote access to justice by working with counsel to make trials shorter, run more efficiently, and thereby more affordable, timely and proportionate.

In addition to our extensive trial experience, our attorneys are also well versed in alternative dispute resolution, such as arbitration and mediation, which often facilitates the resolution of disputes in a cost - effective and timely manner.

Even if you get to file your summary judgment motion, that doesn't mean that the judge will actually rule in a timely fashion (thus saving the expense of preparing for an unnecessary trial) or that you'll win.

Experience working on Oncology studies, Transplanting, Central Nervous System studies, Monitored the progress of clinical trial projects for timely attainment of milestone.

Independently prioritize upcoming cases and records of trials to ensure all tasks are completed to standard and in a timely manner

Legal Intern Central Courts of Long Beach, Long Beach, MS (2006 — 2007) • Typed up courts orders and ensured that any summonses or warrants were timely issued • Prepared files for court dates such as arraignments, bench trials and pre-trials • Handled records management duties by efficiently filing records and ensuring that they are kept confidential • Provided courtroom support by ensuring that all exhibits are properly marked and stored after trial • Assisted in calculating jury fees and ensuring that they are paid and recorded properly

Document Preparation: Assisted attorneys in the timely drafting and filing of legal documents and correspondence supporting case preparation for court appearances, hearings, depositions, trials and meetings.

Given what we now know about the heterogeneity of conduct problems, it is timely to develop and trial novel interventions that are specifically suited to conduct - problem children displaying a callous interpersonal style.

Publication of the results of the PoNDER Trial is therefore extremely timely, particularly as the role of the health visitor is under renewed scrutiny in the context of a wider political debate about how best to provide support to vulnerable families.

The trial court dismissed the lawsuit, finding that the statute of limitations for actions alleging professional malpractice was two years and so the action filed by the Buyers was not timely filed.