Sentences with phrase «trial application for»

However, there was another ground, namely that at a preliminary hearing before trial an application for the defendant to be allowed to give evidence by live video link and that he be allowed to give evidence by live video link had been rejected.

Compilation of an investigational medicinal product dossier (IMPD) for the clinical trial application for two candidate vaccines, allowing them to proceed to phase I clinical trials.

Heidi's unrelenting style can be seen across all areas of Hookipa, including a major role in the clinical strategy, scientific advice and clinical trial application for the Vaxwave cytomegalovirus vaccine candidate HB - 101.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

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.

For example, when we make a big announcement at my company Sage One, an online accounting application for small businesses, we try to beat the high score for opened emails, clicks and triaFor example, when we make a big announcement at my company Sage One, an online accounting application for small businesses, we try to beat the high score for opened emails, clicks and triafor small businesses, we try to beat the high score for opened emails, clicks and triafor opened emails, clicks and trials.

The FDA added that «additional well - controlled clinical trials are needed prior to the resubmission of the [new drug application] for ALKS 5461,» the release said.

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.

It has already begun trials throughout Korea and has the potential to see very quick uptake as it starts being used for real - world applications.

After the trial, the company filed a patent application for the system in the US.

While the founder of the Silk Road sits on trial and many wonder if there is a legal application for bitcoin as a currency, the price per unit has been falling sharply for three months and miners can't afford to stay in business.

Given the clinical trial results underpinning a new drug application for Kite Pharma's lead candidate, which the Food and Drug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investment.

Last April, applications for field trials and direct use for food, feed and processing (FFP) has been filed anew at the Bureau of Plant Industry (BPI).

Last August 29, however, an article in the Philippine Daily Inquirer was published claiming that the applications for the field trials and direct use for food, feed and processing have been «secured.»

Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia.

Spanning an overall area of 2,200 m2 at the company's headquarters in Hamburg, the Center accommodates state - of - the - art pilot plants, equipment for the refinement of milled grain products, a professional kitchen and up - to - date baking technology for application - related trials, as well as a laboratory where products can be analyzed.

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.»

Gluten - free solutions are custom - made The survey's findings have provided valuable insights for ongoing gluten - free trials in the DuPont bakery application center.

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.

There is no better time for ambitious and talented players to get involved at Spurs Ladies and we are now accepting applications for First Team and Academy players to trial for the 2018/2019 season * First Team and Development Team (16 +) Trials:

By the 1990s, it was recognized that the method by which causality is typically shown in scientific studies — the randomized control trial — had limited application for studying the physical punishment of children.

The prosecution counsel, Alex Izinyon SAN, demanded for dates for trial but Nkem Okoro, counsel representing Melaye, persuaded the court to hear his application for bail.

Kanu's lead counsel, Chuks Muoma had written a petition to the National Judicial Council (NJC), claiming that Tsoho made conflicting rulings on an application by the Department of State Services (DSS) to conduct a secret trial for him.

In view of his plea, the prosecuting counsel, Rimamsomte Ezekiel, asked the court for a date for trial, but the defence counsel, R. N. Mbu, objected saying, he had a pending bail application before the court.

After listening to both parties, Justice Dada adjourned the case to March 26, 2018 for hearing of the bail application and April 7, 8 and 9, 2018 for commencement of trial.

«I have also instructed my lawyer to challenge the jurisdiction of the trial court to entertain an ex parte application for the service on me.

According to information available to ghanacelebrities.com, the trial judge refused the application for bail despite alleged health problems of Asante, who's currently on admission at the Korle - Bu Teaching Hospital.

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.

The trial judge also adjourned till Monday, 7th, May for continuation of hearing in a written bail application filed by Melaye's counsel, Chief Mike Ozekhome, SAN, asking for a variation of the remand order placed on him.

Also, Okpeseyi filed an application seeking protection of witnesses in the trial of the former NSA, but Adeniyi adjourned ruling on the application (for secret trial) and for the commencement of trial to February 16.

The tribunal on Oct 21 adjourned his trial in the instance of his plea before the appellate court which had on October 30, dismissed Saraki's application to stop his trial at the CCT for lack of merit.

En Huang, the 31 - year - old Chinese lady, who is standing trial over alleged illegal mining (galamsey), has filed an application for variation of bail conditions at an Accra High Court (Criminal Division).

The suit, which was earlier adjourned for hearing of all pending applications, was however adjourned to June 29 because the trial judge, Justice Ayokunle Faji, was indisposed

The proceedings was stalled as the operatives of the Department of State Service could not produce the ex-NSA in court on time and the need for the other co-defendants to respond to an application by Dasuki to stop the trial.

The court making this known on Monday has also stalled ruling on an application by federal government for a Secret Trial of the immediate past National Security Adviser (NSA).

Meanwhile, Mr. Joseph Daudu (SAN), on Friday restate the essence of the application which he said bordered on the integrity of the court and the ability of the former NSA to prepare adequately for his defence in the trial.

The prosecutor, Ms Mosunmola Balogun from the Lagos State Ministry of Justice did not oppose the bail application but urged the court to impose conditions which would make the defendants available for trial

Metuh had through his application for stay of proceedings, urged the Supreme Court to halt his trial before the Federal High Court pending the outcome of his appeal before the apex court on the no - case submission.

A five - man bench of the apex court made the order in a unanimous ruling in which it dismissed Metuh's application for an order of stay of proceedings of his trial before the Federal High Court.

Meanwhile the court ruling on an application by federal government for a Secret Trial of the immediate past National Security Adviser is still being awaited.

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.

Meanwhile, Usman, in her application, is asking the court to allow her to be tried separately from Fani - Kayode and for her trial to be transferred from Lagos to Abuja for convenience.

The court, in a ruling by trial Justice Hussein Baba - Yusuf, dismissed the application for want of merit.

The decision of the trial judge followed an application filed by Akinshola Olujimi, SAN, seeking for an adjournment.

Dr Olugbumi Usim - Wilson has filed an application to withdraw as a surety to Olisa Metuh, a former Peoples Democratic Party spokesman, standing on trial for alleged money laundering.

The prosecution opposed the bail application, insisting the accused persons if granted bail would not avail themselves for trial.

However, the defense counsel, Folunso Adegalu, urged the court to accede to his bail application dated February 27, 2017 «to enable the defendant prepare for his trial».

The tribunal headed by its Chairman, Danladi Umar, granted the bail application and fixed July 12 for commencement of trial.