Sentences with phrase «trial application with»

Prior to trial the Defendant scheduled a summary trial application with a unilaterally selected date.

IRBs are also included, along with many pages of other information, in drug trial applications with regulatory agencies such as the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland.

Not exact matches

The combo proved non-inferior to competing HIV medicines in a slew of late - stage clinical trials, and Gilead is expected to file a new drug application with the FDA soon.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

When he submits the company's application to move ahead with human trials, Reynolds wants it to be bulletproof.

If your application is rejected twice, you can file an appeal with the Patent Trial and Appeal Board.

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).

Juno's setbacks contrast with the biologics license application planned this year by Novartis, and the rolling BLA in progress by Kite Pharma — which on Tuesday reported positive 6 - month trial data for its CAR T - cell lead candidate.

Myriota commenced commercial trials in 2016 and continues to look for strategic partners with remote IoT applications.

If myelofibrosis trial results are consistent with previous observations, the healthcare behemoth will help fund larger trials in order to support New Drug Applications.

The offer includes a 30 day trial with the opportunity to return items that are not applicable to the customer's chosen application.

The pilot equipment, which is capable of handling multiple trials in small batches and applications, can be scaled up with a high - degree of repeatability in industrial set - up.

In this randomized, double - blind clinical trial, virgin coconut oil was the clear winner: «among pediatric patients with mild to moderate AD, topical application of virgin coconut oil for eight weeks was superior to that of mineral oil based on clinical (SCORAD) and instrumental (TEWL, skin capacitance) assessments.»

In Philippines, the Golden Rice issue was stirred anew with the renewed application for field trial and direct use last February 2017 despite the absence of public dialogue.

The prosecution lawyer Rotimi Jacobs confirmed that he has been served with application for bail of all the accused persons and with the consent of all the lawyers in the trial, the trial judge, Justice Peter Affem adjourned hearing in the bail application until Wednesday the 16th of December 2015.

Justice Ahmed Mohammed in a ruling on the accused persons» bail applications also ordered that they should deposit their passport with the court pending the determination of their trial.

But the trial judge after hearing the arguments of both parties dismissed the application with Honeywell Group's lawyer, Bode Olanipekun, consequently praying the court to continue the hearing of the suit with the defendant (Ecobank) opening its case.

Tarfa urged the court to strike out the application filed by the prosecution in order to continue with the trial.

Meanwhile, Rotimi Jacobs, counsel to the EFCC, in opposition urged the court to dismiss the application and proceed with the trial.

The defence counsel also pleaded with the trial judge to consider the bail application, saying his client has been with the police since April 24 and was released on bail on Wednesday by an Abuja magistrate court only to be rearrested by the police, adding that his client case should be for prosecution and not persecution.

The Federal High Court sitting in Lagos has fixed March 1hear an application challenging its jurisdiction in the trial of a former Aviation Minister, Femi Fani - Kayode, charged with laundering N4.6 billion.

In three randomized trials, treatment of chronic low back pain with radiofrequency denervation, a procedure that can be performed with different techniques including the application of an electric current to the pain - conducting nerve, resulted in either no improvement or no clinically important improvement in chronic low back pain, according to a study published by JAMA.

Another field that might appeal to your desire to work in a role with clinical applications is that of clinical trials.

Outcomes of children and young adults with cancer have improved, primarily due to enhanced understanding of tumor biology and due to the clinical application of biological discoveries through multicenter clinical trials.

And because one widely discussed application is to introduce gene drive — modified mosquitoes in malaria - prone developing countries, the academies cautions against doing so until the countries involved are equipped with the expertise and infrastructure to deal with these trials.

He moderated a premeeting session where scientists discussed advances with officials of the U.S. Food and Drug Administration, which would review any application for a clinical trial.

As the Spanish authorities mull the application, Oxitec is continuing with an even bigger trial to combat dengue fever in Jacobina, a city of 50,000 people in the Brazilian state of Bahia.

Raman says the next big steps are in overcoming the technical challenges of delivering the drug, and completing the experiments essential to file for an Investigational New Drug Application with the Food and Drug Administration to start clinical trials.

The $ 1 million grant will be used for preclinical trial work with the goal of submitting an Investigational New Drug application to the FDA to begin clinical trials.

Along with the development of investigator initiated clinical trial concepts, the application of immunotherapies and cancer vaccines to clinical trials.

As a Web Applications Engineer he contributes extensive experience with relational database technologies such as MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web aApplications Engineer he contributes extensive experience with relational database technologies such as MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web applicationsapplications.

CBR is dedicated to advancing the clinical application of cord blood and cord tissue stem cells by partnering with institutions to establish FDA - regulated clinical trials for conditions that have no cure today.

ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence.

Comprehensive integration with other applications and database systems, e.g. electronic medical records, clinical trial management systems, LIMS, and other research applications such as genomic or proteomic databases

Initially founded in 2011 as a Heart Institute, our treatment protocols were later expanded to include adult stem cell therapy for patients with severe and chronic medical needs that, per scientific research, clinical trials and application, can be safely and potentially efficaciously treated with patients» own stem and regenerative cells.

The researchers have been in discussions with the FDA and are preparing an application for an initial clinical trial in patients with IPF.

Preliminary analyses of the results of the first combination trials, which show higher response rates than with either agent alone, offer some optimism that these locoregional therapies will find application — as treatment for patients who can not tolerate systemic immunotherapies, to alleviate locoregional morbidity, and perhaps even to «prime» the immune system.

A drug company filed its application in early 2011 for the drug naltrexone for weight loss; in clinical trials, naltrexone was successful, with participants losing 22 pounds per month by reducing calorie intake 400 calories per day.

It will also be important to determine the effects of IER in other populations, for example in individuals with more profound metabolic derangements such as those with established T2DM, the evidence for which is relatively sparse.36 Additionally, given that several rodent and human IER (50 - 100 % ER on restricted days) trials have demonstrated metabolic improvements in the absence of overall ER 15, 22, 27, 31, 53,105, one can speculate that IER may have potential applications within non-overweight populations and as a maintenance strategy post-weight-loss.

Rather than waiting for the glacial progress of modern biomedical research, which needs decades to assemble sufficient evidence to get an application for funding for a clinical trial past skeptical reviewers, anyone with a brain or neurological condition should simply experiment with a ketogenic diet themselves to see if it helps.

The V - 8 engine — Bryan Goodman lists V - 8 engine manufacturers up to 1939 with special attention to the Ford V - 8 and its many applications / Louis Vuitton Concours D'elegance — The scene at the Hurlingham Club for the filth Concours D'elegance in June / All about the Gwynne — Nick Baldwin and others visit Bill Peacock the doyen of Gwynne affairs in Cornwall / Made in Burton - on - Trent — Mike Worthington - Williams traces the historical progress of the Ryknield Baguley Ace and Salmon manufacturers / 1902 «Curved Dash» Oldsmobile — A beautifully preserved example of America's first volume - produced automobile is described for us by David Hawtin / MG NA Allingham Coupe — The Editor charts the history of the six - cylinder MG NA Magnette and test - drives a coachbuilt 1934 Allingham coupe owned by Keith Portsmore / Gordon Bennett Trial — Zoe Harrison reports on the 90th anniversary of the Isle of Man tTrial — Zoe Harrison reports on the 90th anniversary of the Isle of Man trialtrial.

Along with Samsung's usual business features, such as its Enterprise grade security and BYOD management layer, Knox, the Pro tablets come with Samsung's Remote PC access application, a 6 - month WebEx free trial and a full copy of

Along with Samsung's usual business features, such as its Enterprise grade security and BYOD management layer, Knox, the Pro tablets come with Samsung's Remote PC access application, a 6 - month WebEx free trial and a full copy of Hancom Office for working with Microsoft Office docs.

Convert your free trial demo account to a live account by selecting LOG IN > Finish an Application on our website and logging in with your username and password.

The Court is further advised that, in the event that the Plaintiff loans are repurchased and in the IBR, no trial in this adversary proceeding will be required as to ECMC or DOE, and being further advised that both the Plaintiff and ECMC and DOE have agreed to the dismissal of this adversary proceeding as to ECMC and DOE only so that Plaintiff may proceed with the application process, good cause appearing, and being otherwise duly advised in the premises, it is hereby

Once your application is reviewed and approved we honor a two - week trial period to make sure your new pet fits in well with your family and lifestyle, adoption fees will be deposited after the two week trial period.

Until recently, it was still possible for intellectual property attorneys to succeed using trial - and - error - based philosophies of patent prosecution, particularly when working with applications that were not submitted to high - technology art units.

Their goal is to provide clients with timely and sensitive service whether through legal agreements, court applications, or at trial.

2 By agreement the application was heard together with the trial.

Just two amongst the appalling issues examined here are the direction by the judge to proceed with capital changes, overruling a prosecution application reducing them, and the trial being forced on in the absence of significant witnesses.