Sentences with phrase «full approval in»

However, this position seems suspect since they're launching without having full approval in the United States, let alone foreign jurisdictions.

Not exact matches

Meanwhile, small business loan approvals at small banks, which generally have been focusing on SBA loans in recent months, dipped to 48.7 % in December — a full percentage point from the previous month.

A Bank of New York Mellon spokesperson wrote me in an email that their «resolution and recovery process involves full Board review and approval.»

Though the U.K. remains a full member of the European Union until, at least, March of 2019, transitional talks need to end by October of this year to allow enough time for parliamentary approval across the EU — giving U.K. and EU negotiators less than 10 months to decide how both sides will cooperate in the future.

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).

For now, the only country where Airobotics has received full approval to operate is in its home country of Israel, which — partly because of its position in the Middle East and ongoing conflicts with neighbors — has taken a leadership role globally in building defense systems and doubling down on using technology to advance itself.

Roche, the world's biggest maker of cancer drugs, had won fast - track approval last May in the United States for Tecentriq against bladder cancer but full approval hinged on further trials.

Following the publication of full data from a late - stage study of La Jolla Pharmaceutical Company (NASDAQ: LJPC)'s LPJC - 501, a proprietary formulation of angiotensin II, SunTrust Robinson Humphrey said it expects approval in 2018.

As thought leaders and innovators in the private market, Liquid M Capital has approvals to transact the full stack of private and unregistered securities.

But stating «in the name of» is essentially giving notice that you are acting under direction of an authority or at least with full confidence of that authority's approval.

The final report — not a magisterial document, but expressive of the synod's will — was published with the full approval of the Pope, and is by any measure «conservative» in nature.

The multimillion dollar scheme, which includes new offices and industrial production space, was granted full planning approval by York City Council in September 2011.

Despite a full FDA approval, word of Stevia spread, and so today, Cargill, an industrial food producer on the same level of Monsanto, has created a «Stevia based product» called Truvia, which is now being tested for use in diet drinks and other consumables.

Our experience enables clients in all tiers of the industry to meet their full range of legal challenges — from obtaining regulatory approval to launching new brands to negotiating international trade agreements.

ITT Technical Institute has gotten full approval from the village board to move into 3800 N. Wilke Road in Arlington Heights.

The County Board's Development Committee recommended full board approval of the plan for a 6,000 - square - foot fieldhouse in Glenbriar Park, on Butterfield Road east of Illinois Highway 53, near Lombard.

I was awaiting approval from my local milk bank to donate, and in the meantime, I had a freezer full of milk that would have been too old for the bank by the time I was approved.

Christie, whose approval ratings are pretty decent — for a Republican governor in tough economic times — with narrow positive margins in the three most recent polls, may not take the full brunt of the beating.

With full support of the Republican majority, Sessions appears to be on track to win approval in the Judiciary Committee, on which he serves, and in the floor vote.

This new alliance on the five - member board resulted in votes to rescind both the town's Rules of Procedure in conducting town board meetings, and to rescind a town policy requiring individual town board members obtaining full - board approval before utilizing services of the town attorney.

In August of this year, Tioga Downs was given the final step of approval to go forward with the full casino.

(4) The independent panel shall report as approved for each judicial position all highly qualified persons who make application to the panel, provided that if the number of highly qualified applicants exceeds three times the number of existing vacancies to be filled in such position (determined as of the time the panel renders its report), the independent panel shall report as approved the most highly qualified applicants in a number equal to three times the number of vacancies to be filled in such position, provided further that if the number of highly qualified applicants is less than three times the number of vacancies to be filled in such position the independent panel shall report as approved the most highly qualified applicants in a number equal to not less than two times the number of such vacancies, provided further that the following categories of applicants who are eligible for reelection or reappointment shall be reported as approved if their performance during their term of office merits continuation in office, and no other applicants shall be reported as approved for their vacancies: (a) a judge or justice completing a full term of office seeking re-election to that office, or (b) an interim Supreme Court justice who has been appointed by the Governor to fill an existing vacancy no later than the previous June 1 after approval of the Governor's screening panel, who has been confirmed by the State Senate and has assumed office no later than the date the panel renders its report, and who otherwise would not be required to make application to the independent screening panel pursuant to the provisions of sub-paragraph (3).

The approval came days after Ghana ratified the Paris Agreement on climate change at the UN in New York, signaling its full commitment to linking its climate action and development path, said a release.

After a full period in office, parties very rarely manage to actually win more approval.

NYC Mayor Bill de Blasio gave his stamp of approval to a city commission's plan to raise the salary of elected officials, and to make the City Council a full - time job with strict limits on outside income, but said he personally won't accept a raise in his first term.

Cahill said his proposal would «provide for a more modest amount of gaming devices to be installed at two existing venues in the County through an open bidding process that as a prerequisite demands full local approval.

Fred Thiele (D - Sag Harbor) said he introduced the moratorium bill to allow for a suspension of the charge to give a full airing in the legislature to a costly proposal that was not fully vetted before its approval by the PSC.

Mayor Bill de Blasio gave his stamp of approval to a city commission's plan to raise the salary of elected officials, and to make the City Council a full - time job with strict limits on outside income, but said he personally won't accept a raise in his first term.

It was not a full - fledged, formal endorsement, though official backing from a popular govrnor with a 70 percent approval rating would be key for an embattled incumbent in a moderate Senate district.

A proposal to amend city law to allow a shooting range to operate in a former medical practice on Prince Street in Midtown will go to the full Common Council for approval.

While the bill is still awaiting approval in three separate committees — Budget and Appropriations, Legislation, and Public Safety and Social Services — the Democratic Caucus is pushing for the committees to approve the proposal in order to move forward on a late night vote of the full 17 - member county Board of Legislators on Monday, July 17.

Recent polls show Paterson's approval rating hovering between the 20s and 30s, but the governor said on Sunday that he is still planning on running for a full term in 2010.

Westchester County based - Riverkeeper has filed a lawsuit challenging the state Public Service Commission's approval to reactivate the Danskammer Power Plant in the Town of Newburgh without conducting a full environmental review.

In the coming months, the Council will hold committee hearings and subsequently vote on the matter — the full Council approval of the project, in whatever exact form it is finalized, will likely occur around Labor DaIn the coming months, the Council will hold committee hearings and subsequently vote on the matter — the full Council approval of the project, in whatever exact form it is finalized, will likely occur around Labor Dain whatever exact form it is finalized, will likely occur around Labor Day.

Even though this plan received full approval from the FAO, it was rejected at a meeting in Delhi of the Consultative Group for International Agricultural Research, the informal group of donors that funds the IARCs.

According to the QIMR, approval was given on compassionate grounds, «because the patient was a scientist with full knowledge of the project and therefore in a position to evaluate the risks involved».

Perhaps the state's most striking advance was the approval by the Public Utility Commission of Texas in 2005 of a plan to build a matrix of new transmission lines across west and central Texas to tap the full potential of its wind power.

The move — which would need approval from the full Senate, the U.S. House of Representatives and the White House to become reality — marks the latest twist in a long and contentious debate over how to sustain an expensive and delay - prone satellite fleet.

The use of autologous cell products in «non-homologous» applications will require full FDA approval.

So, with full approval by Jonathan Landsman, Host of NaturalHealth365, we have created this resource guide of the most popular products to assist you in making an informed decision about your health.

A Lacey Perspective accepts (on an approval basis) product samples for blog review or showcase in a post (with full disclosure).

The Avengers are represented mostly by Robert Downey Jr.'s Tony Stark, in a cameo, who isn't quite ready to give Peter his full Avengers seal of approval.

The full trailer for The Twilight Saga: Eclipse debuted on today Oprah, and if her stamp of approval isn't enough to get you excited about the third film in the Twilight series, I don't know what is.

In the piece, we discuss New Jersey's Assembly Bill 3105, which would block approval of virtual charters for one year while a study of the general effectiveness of full - time online schooling is conducted.

The governor is in full control of whether the DCED can issue these approval letters and issue them in time for this tax credit year and not jeopardize so many organizations that are really in the field to help low - income children to gain access to educational opportunities across the board.»

Both have been assigned to a backlogged Senate rules committee, and would need to have the full chamber's approval by the legislature's April 27 crossover deadline to be considered in the state House this session.

As part of their monitoring and approval process for teacher preparation programs, states should prioritize identifying sustainable funding strategies in cooperation with local education agencies and institutes of higher education, and should incentivize both teacher preparation programs and school districts to provide teachers - in - training at least one full year of clinical experience prior to a teacher becoming the teacher of record.

The University of Florida's educator preparation programs were granted full, continued accreditation by the National Council for Accreditation of Teacher Education (NCATE) and continued approval by the Florida Department of Education in 2010.

The Metropolitan Preparatory Academy proposed in Richmond has not received full local board approval.

Although the corporate education reform entity, Relay School of Education, has recently been prohibited from working in California and Pennsylvania, Governor Dannel Malloy's political appointees on the State Board of Education are poised today to grant the controversial teacher training scheme, «full program approval» to operate in Connecticut.