Sentences with phrase «for full approval»

The settlement is still waiting for a full approval by the FTC.

The CPUC will consider the resolution for full approval of these additional five PPAs at its September 24th meeting.

The company states that they will wait for full approval of their plans after the Green Code goes into effect.

Not exact matches

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.

Kinder Morgan said it had previously announced a «primarily permitting» strategy for the first half of 2018, focused on advancing the permitting process, rather than spending at full construction levels until it obtained greater clarity on outstanding permits, approvals and judicial reviews.

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.

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.

If the Adler proposal is approved by a Chicago Park District committee Wednesday, it will be submitted for approval to the full board at its Dec. 9 meeting.

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.

The cap has FDA approval for the treatment of full - term babies only.

I also made sure to begin meats on the early side at 6 months (with my pediatrician's approval) because I am 100 % convinced that whatever foods help adults feel full should help babies feel full, assuming the digestion is prepared for them.

Stay tuned on Wednesday for more details on the governor's congestion pricing plan, though full details may still not be released till the end of this year, signaling a slow and contested approval process for this plan.

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.

However, the approval of the subcommittee is considered to be a last step for the project, as the full Council almost never votes against its subcommittees, Crain's reported.

(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).

After years of advocating for this new station, the MTA Board approval means we are yet one step closer to not only ensuring local residents have the transportation options they deserve but also making sure Elmhurst lives up to its full economic potential.»

Genting has been lobbying hard for full - scale gaming, and the legalization process, which requires the approval of two successive legislatures and a state referendum, is moving forward.

WASHINGTON HEIGHTS — The historic United Palace Cathedral got a long - awaited approval for landmark designation by the Landmarks Preservation Commission Tuesday — but the cathedral's owners and local elected officials have mounted a full - scale fight against the decision.

The full impact of these actions is yet to be seen, but the most obvious for voters will likely be the approval of Senate Bill 202.

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.

The Common Council's Legislation Committee approved the latest version of the Green Code Tuesday and sent it for full Council approval on Tuesday.

NORTH CREEK — The Gem Radio Theatre is presenting «Movies by the River» after receiving approval from the Johnsburg Town Board for occupancy tax funding for the rights to show four, full - length family movies.

Following testimonials that managed health care plans often fail to adequately cover the full costs for rehab programs, the legislation now prohibits insurers from requiring prior approval for emergency supplies of these medications.

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.

At the end of the evening, CB3 members accomplished what seemed impossible to many not so long ago: unanimous approval of a set of planning guidelines (you can read the full document here) for a 7 - acre development site the neighborhood has been fighting over for 43 years.

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.

The proposal, which was approved Monday by the MTA's bridges and tunnels and finance committees, is expected to win approval from the full board when it goes up for a vote on Wednesday, according to Staten Island MTA board member Allen Cappelli.

CEO Rex Tillerson for secretary of State, paving the way for easy approval by the full Senate.

The FDA 510 (k) clearance pathway does not require the rigorous testing and evaluation that is needed for full FDA pre-market approval of class I (high - risk) devices.

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.

He said he hopes to move her nomination for approval by the full Senate by the end of June.

They then add: «full transparency and early engagement with the public will be crucial for their approval.»

Thus, for the specific example you gave of using autologous bone marrow stem cells injected into the brain, this scenario would indeed require full FDA approval as it does not meet the criteria of homologous use, as you said.

Read full, original post: The Sainsbury Laboratory received approval for a four - year trial of genetically modified (GM) potatoes

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

The country is now one step closer to obtaining the full approval for a visa - free entry to European Union for its citizens after a key committee voted to accept the proposal on Monday 26 September.

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.»

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 state Department of Education today announced approval of nine new charter schools for September, but said the New Jersey Virtual Academy Charter School, a full - time online charter school, would instead be given a «planning» year to further develop «academic and operational components.»

It is assumed that the user will require no more than 20 - 30 citations, will be using a legitimate password / subscription for invoice purposes and has local approval to order, receive and provide payment for a full - text document or citations.

Financial plans must show full funding for the project and are subject to review and approval by the Bureau.