Sentences with phrase «additional approvals in»

«Zoetis continued to expand the availability of... Simparica into new markets, with additional approvals in Chile, Panama, the Philippines and Switzerland,» the company stated.

Amarin anticipates additional approvals in the MENA region, including potential additional approvals in 2018.

Not exact matches

Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost of accommodating, announced increases in the build rates of certain aircraft; 6) the effect on aircraft demand and build rates of changing customer preferences for business aircraft, including the effect of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result of global economic uncertainty or otherwise; 8) the effect of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution of key milestones such as the receipt of necessary regulatory approvals, including our ability to obtain in a timely fashion any required regulatory or other third party approvals for the consummation of our announced acquisition of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and agency regulations, both in the U.S. and abroad; 20) the effect of changes in tax law, such as the effect of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability of raw materials and purchased components; 23) our ability to recruit and retain a critical mass of highly - skilled employees and our relationships with the unions representing many of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment of interest on, and principal of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness of any interest rate hedging programs; 28) the effectiveness of our internal control over financial reporting; 29) the outcome or impact of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks of doing business internationally, including fluctuations in foreign current exchange rates, impositions of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.

Certain matters discussed in this news release are forward - looking statements that involve a number of risks and uncertainties including, but not limited to, doubts about the Company's ability to continue as a going concern, the need to obtain additional funding, risks in product development plans and schedules, rapid technological change, changes and delays in product approval and introduction, customer acceptance of new products, the impact of competitive products and pricing, market acceptance, the lengthy sales cycle, proprietary rights of the Company and its competitors, risk of operations in Israel, government regulations, dependence on third parties to manufacture products, general economic conditions and other risk factors detailed in the Company's filings with the United States Securities and Exchange Commission.

The Food and Drug Administration (FDA) wasn't resting on its laurels in 2017: The agency under new commissioner Scott Gottlieb approved 46 new medicines — i.e., completely new therapies, not just additional indications on already - approved drugs — the highest number of approvals in more than two decades.

Borrowers should be prepared, however, to meet many of the same criteria required for a traditional loan approval at the bank including some additional requirements set in place by the SBA.

The rule, which does not need additional approval, requires that workers in assignments related to many federal contracts receive one hour of paid sick leave for every 30 hours they work, for up to 56 hours of leave a year.

As circumstances require, we may apply for registration and / or licensure in additional states — however, we may not conduct any business in such states prior to the receipt or acknowledgment of such regulatory approvals as may be required.

USDA eligibility is based on a combination of household size and geography, in additional to the typical mortgage approval standards such as income and credit score verification.

So what: Interventional cardiologists are increasingly relying on Abiomed's medical devices to boost patient blood circulation before, during, and after catheterization lab procedures, and in 2015, the FDA approval of its devices in additional high - risk heart procedures sent revenue zipping 47 % higher to $ 76 million last quarter.

Amicus Therapeutics, Inc. (NASDAQ: FOLD) announced the path forward for U.S. regulatory approval for migalastat, including an additional trial in Fabry disease, focused on gastrointestinal (GI) symptoms.

These risks, delays, and uncertainties include, but are not limited to: risks associated with the uncertainty of future financial results, our reliance on our sole supplier, the limited diversification of our product offerings, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

To date, because of many collaborative efforts, 64 countries have adopted a law with most or many provisions of the Code in place while an additional 23 countries have draft legislation pending approval.

The state legislature has a game plan: get approval for debt, gambling or additional taxes by promising they will be used for things like the environmental trust fund, the Second Avenue Subway and East Side Access, mass transit in general, and in - classroom schools.

A company linked to Trump has been granted approval from the Chinese territory of Macau for additional trademarks, including casino services, to develop the «Trump» brand in the world's biggest gambling center.

The other questions addressed Conflict of Interest Board approval of de Blasio's involvement in non-profit entities used to fundraise and support the mayors agenda, de Blasio's recent proposal for an additional and conditional $ 20 million for the New York City Board of Elections and whether Deputy Mayor Alicia Glenn's office was aware of the Rivington House deed debacle for a month prior to advising the mayor.

HCR said the determination in the Biltmore project was required merely to provide the project with additional time to secure local approvals, and was not required due to low scoring.

The governor's proposal would 1) prohibit state sales tax abatements unless a project is in a specific industry eligible for Excelsior tax credits (think «bureaucracy» and «hurts small business» here...), 2) require additional approvals by the relevant Regional Economic Development Council (REDC) and Empire State Development (think «unnecessary oversight and delays» here...), and 3) shift the abatement of state sales tax to a refund that might be issued sometime down the road (think «uncertainty» and «cashflow» here...).

Although the administration has lauded the deal as a potential source of $ 140 million in additional tax revenue over the course of 40 years, lawmakers have approached the plan with caution, criticizing Astorino's attempt to fast - track its approval by tying a Board of Legislators» decision to a required Dec. 27 budget deadline, and for not sending out a formal request for proposals.

A bipartisan effort to give New York additional say over large - vessel anchorage locations on the Hudson River has won final approval in the state Legislature and is heading to the governor's desk.

When the County Executive, Comptroller, County Clerk, Sheriff, District Attorney, or a department head, needs legislative approval for some action which is required for the proper functioning of county government, be it the approval of the annual budget or the change in the title of a county job, a letter is sent to the legislature, often accompanied by additional information which can be used by the legislators in making a decision on the matter.

It is worth noting that this reckless commitment above the budgeted amount was questioned by the Public Procurement Authority (PPA) in December 2016 when COCOBOD needed to seek approval to award additional contracts and the Authority inquired about the availability of budgetary provision to enable it to approve the requested contract awards.

Among the question topics were his reaction to the pre-K funding contained in the state budget agreement and the absence of his proposed income tax surcharge, what funding has been provided in the state budget for the middle school after school portion of his initiative, the outlook for his as yet unfulfilled request for state approval of additional red light cameras in the City and the lingering pain of Bill Buckner's bobble in Game 6 of the 1986 World Series.

Supervisor Gromack deserves our particular gratitude for his willingness to take an additional step towards the position of the minority Party on the Town Board and for leading the final deliberations of the Board which resulted in an unanimous approval of this budget.

Van Horne has been able to advance the trial so quickly in part because it did not require additional FDA approval, since it piggybacks on an approved procedure and uses a patient's own nerve tissue.

It calls for the hospital to be more independent from KI, especially in hiring decisions, and recommends additional training for staff on regulations surrounding ethics approval and new medical products.

As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity - related conditions.

These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

However, the most recent approval of niraparib came through without any restrictions in terms of having additional tests done to indicate that there may sensitivity.

The FDA decided in this case that the benefit was sufficient to warrant approval of the drug without requiring any additional biomarker testing.

Following Dr. Mendell's successful phase I trial described in the NEJM publication, additional studies to enable FDA approval of the first gene therapeutic for a fatal disease of infants are now underway.

In the process, they set up an approach applicable to future samples — including an additional set of 1.08 million cord blood, bone marrow, and white blood cells that the team, in collaboration with Broad Institute Member Nir Hacohen and Alexandra - Chloe Villani, has already processed and will release once all approvals are confirmeIn the process, they set up an approach applicable to future samples — including an additional set of 1.08 million cord blood, bone marrow, and white blood cells that the team, in collaboration with Broad Institute Member Nir Hacohen and Alexandra - Chloe Villani, has already processed and will release once all approvals are confirmein collaboration with Broad Institute Member Nir Hacohen and Alexandra - Chloe Villani, has already processed and will release once all approvals are confirmed.

Many of those atop the list were recognized with nominations and, in many cases, major awards, but such an extreme degree of public approval also tends to invite additional scrutiny.

(Students allowed to take (without local district approval) online courses for credit and use them to meet high school graduation requirements in 2 additional states.)

This is inconsistent with Congressional intent to provide an additional year as evidenced by the approval of the Fiscal Year (FY) 2016 omnibus bill in December 2015 that delayed ESSA implementation by a year.

However, and I'm certainly not an expert in this and don't have the answers, will getting approval to offer apprenticeships mean that TKAT is stretched further or will it result in additional income meaning more resources can be brought in which will help alleviate the current pressure?

And if identified schools in an LEA don't make sufficient progress to meet state «exit» requirements, Section 1111 (b)(3)(B) broadens state authority to act directly — potentially without LEA approval — to «take additional improvement actions» to implement «alternative evidence - based State - determined strategies» for improving the district's comprehensive and targeted improvement schools.

New Haven, CT — The Northeast Charter Schools Network today sent the following statement in response to additional charter school seats that were proposed for approval to the State Board of Education on Wednesday.

Instead of choosing among four contentious turnaround models (turnaround, restart, school closure, and transformation), schools have two new additional options: One option allows state agencies to establish any whole school improvement strategy for use by local education agencies with approval from the U.S. Secretary of Education, and the other option permits schools to partner with outside organizations who have successful records in school turnarounds.

In its approval notice, the department «highlighted several aspects of Arizona's state plan, including the ability of elementary and middle schools to earn additional points in its accountability system for accelerating student achievement.&raquIn its approval notice, the department «highlighted several aspects of Arizona's state plan, including the ability of elementary and middle schools to earn additional points in its accountability system for accelerating student achievement.&raquin its accountability system for accelerating student achievement.»

Even following statewide voters» approval of Proposition 123 in 2016, a segment of small charter schools serving a combined 84,000 Arizona students still faces $ 20 million in additional state cuts in the next fiscal year.

Additional legislation, pending approval by voters in the upcoming Oct. 22 elections, offers another opportunity to get the massive debt paid down.

The Northeast Charter Schools Network today sent the following statement in response to additional charter school seats that were proposed for approval to the State Board of Education on Wednesday...

In other news, 17 additional states have received approval for their plans to ensure that all students have access to great teachers from the U.S. Department of Education.

BloomBoard and Digital Promise are already approved for statewide credit hour equivalency in Texas, Illinois, and North Carolina, with additional states expected to provide approval in the coming months.

If an SEA needs additional time to plan for implementation of the flexibility, it may request approval to use as its annual measurable objectives (AMOs) for adequate yearly progress (AYP) determinations based on assessments administered in the 2011 - 2012 school year the same AMOs that it used the previous year.

After approval, we made substantial additional investments in licensing fees, integration fees, and server fees so that we could open our ebook store on December 2, 2010.

USDA eligibility is based on a combination of household size and geography, in additional to the typical mortgage approval standards such as income and credit score verification.

Subject to our approval, in our sole discretion, as to both number of persons and specific persons requested, you may request in writing to us to designate certain non-Account holders as Authorized Users of your Account by issuance of additional card (s) in the name (s) of such Authorized User (s).

Overdraft credit products eligibility — Credit products are subject to eligibility requirements and normal credit approval and may be subject to additional charges as detailed in the account agreement.