Sentences with phrase «on application and approval»

But when it comes to actually providing credit, many still rely on application and approval processes that are as offputting as they can be for small, growing businesses.

Not exact matches

On Thursday, Bristol - Myers Squibb abruptly ditched an accelerated approval application for a combo of its rival immunotherapy Opdivo and an older drug called Yervoy.

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.

The Danish pharmaceutical group and its Japanese partner, Takeda Pharmaceutical Co, have submitted an application to the U.S. Food and Drug Administration for approval of its antidepressant, vortioxetine, Lundbeck said on Tuesday.

Feb 14 - Federal Communications Commission Chairman Ajit Pai on Wednesday proposed the approval of an application by Elon Musk's SpaceX to provide broadband services using satellites in the United States and worldwide.

If you apply, expect barter companies to check your Dun & Bradstreet credit rating and vendor references, although the application and approval process should be easier than with a bank loan; on credit lines worth more than $ 10,000, owners may also have to sign personal guarantees.

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).

«Precision medicine is already positively affecting providers (for example, by reducing ED visits by 30 % through application of molecular profiling treatment strategy); payers ($ 25 billion expected annual spending on genetic tests by 2021, and 45 % of FDA approvals were geared toward targeted therapies in 2013); and pharma (the pharmacogenomics market is expected to be $ 7.5 billion by 2017).»

We continue to call on the province to encourage civic levels of government to expedite the application, approval and permitting processes.

The California court granted final approval to the settlement on March 11, 2008 and subsequently granted plaintiffs» counsel's fee application and dismissed the action.

He said Qualcomm withdrew its application for approval from Mofcom this week and, according to a statement the ministry posted on its website later, the application has been re-submitted.

Currently two applications on Golden Rice are submitted at the DA - BPI and awaits approval.

And, just in case there was doubt, the company put out a statement on Friday reiterating its confidence in achieving crucial Chinese regulatory approval to export its infant formula from next January, noting it had submitted its application in May and some manufacturer approvals had already been grantAnd, just in case there was doubt, the company put out a statement on Friday reiterating its confidence in achieving crucial Chinese regulatory approval to export its infant formula from next January, noting it had submitted its application in May and some manufacturer approvals had already been grantand some manufacturer approvals had already been granted.

Unconscionable conduct (agrees with NFF that they have not provided protection and support reforms «to provide transparency in the supply chain» and recognise that «certain classes of suppliers... are predisposed to suffering from a special disadvantage...»; misuse of market power (legal framework must «level the balance of market power in negotiations...», «ensure transparency in the transmission of market prices» and «not allow for final market risks to be borne by the primary producer» and provide «transparency of contract processes» - specifically, Canegrowers supports effects test and a process giving ACCC greater power to «regulate anti-competitive behaviour and impose penalties», shifting «the decisions framework from the judicial system to a regulatory system» which would make it more accessible to small producers); collective bargaining (notes limits of Sugar Industry Act (Qld); authorisation and notification approval costly and limited and not a viable alternative - peak bodies should be able to «commence and progress collective bargaining with mills on behalf of their members» and current threshold too restrictive)» competitive neutrality (mixed outcomes - perverse outcomes in the case of natural monopolies - suggest remove «application of competitive neutrality provisions to natural monopoly essential services»)

Changes to competition laws (milk wars discussion and recommendations relating to MMP (introduce effects test), predatory pricing (recommend Minister direct ACCC to investigate Coles for breach of s 46 relating to predatory pricing), unconscionable conduct (suggest it be defined), statutory duty of good faith, unfair contract terms (seeks «recognition of the competitive disadvantage faced by farmers» and extension of unfair contract terms protection to small business), collective bargaining (seeks relaxation of public interest test for boycott approvals in agriculture markets, increase «ability for peak bodies to commence and progress collective bargaining and boycott applications» on behalf of members - and further dairy specific recommendations, ACCC divestiture power (wants ACCC to have similar divestiture powers to Comp Commission in UK - «simpler process of divestiture», ACCC monitoring powers (wants Minister to direct ACCC to use price monitoring powers to «monitor prices, costs and profits relating to the supply of drinking milk») and mandatory code of conduct (wants mandatory code and «Ombudsman with teeth to ensure compliance»)-RRB-.

Of the 125 applications to the Illinois Department of Conservation, 32 received money in this fiscal year and 37 in the next fiscal year, contingent on the General Assembly «s approval.

On December 13, 2012, the Park District completed its review of the application and issued the approval to the Illinois Nativity Scene Committee as it had satisfied the insurance and other Park District permit requirements.

The Executive Order E01, which was signed by His Excellency, Vice President Prof. Yemi Osinbajo on 18th May, 2017, ensures that citizens have complete clarity on all government requirements and processes, better cooperation and improved information sharing among MDAs, as well as requiring proper communication of approval or rejection of applications to Nigerians within the stipulated timeframe.

CityLand article on BP Adams recommending the approval of a land use application for the construction of 251 affordable units above a revamped local vendor market and community facility in Flatbush.

Krumpter, who is currently ranked a captain and expected to become village police chief by early next year, received approval from the state Civil Service Commission at its October meeting for what is known as the Section 211 waiver, which was requested by the village through a formal application submitted on Aug. 21, commission spokesman Jian Paolucci said.

Section 2 (1) of the Terrorism Act states that «where two or more persons associate for the purpose of, or where an organisation engages in: (a) participating or collaborating in an act of terrorism; (b) promoting, encouraging or exhorting others to commit an act of terrorism; or (c) setting up or pursuing acts of terrorism, the judge in chambers may on an application made by the Attorney General, National Security Adviser or Inspector General of Police on the approval of the President, declare any entity to be a proscribed organisation and the notice should be published in the official gazette».

Kachikwu said that he had had discussions with the Department of Petroleum Resources (DPR), whose statutory functions included processing application for various licenses, permits and approvals across the oil and gas value chain, on the matter.

Mr. Speaker, Section 17 (1) of the Act in issue provides: «Subject to this section, the Minister may on an application and with the approval of the President grant the status of right of abode to any of the following persons: a) a Ghanaian by birth, adoption, registration or naturalization, within the meaning of the Citizenship Act who by reason of his acquisition of a foreign nationality has lost his Ghanaian citizenship; and b) a person of African descent in the Diaspora.

Grant amounts will be based on FEMA assessed damage levels as well as applications for new infrastructure and other mitigation, and will be awarded once the community's plan is complete and submitted to the state for approval.

I suspect that most of the public probably would not want to see elected officials have the power to approve or deny every project, because it could open the door to favoritism or inconsistent application of the law to give approval to some property owners and deny it from others based on who knows who rather than on the merits of the application.

Later this year, they'll seek FDA approval for a new cancer drug and request an additional application for Arcalyst, their first product on the market.

Mill has also vowed to shorten the time from application to funding from an average of about 2 years to 120 days, and groups must start work on a funded project within 45 days of approval.

(2) that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS - supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he shall not participate in any PHS - supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan;

At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval.

In response to mounting concerns about the adequacy of protection of research participants, at a regulatory level, increasing attention is being focused on safety and confidentiality of human subjects participating in research protocols.26 - 28 Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submission.

On March 27, 2014, the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration will review the premarket approval application (PMA) for the company's Cologuard stool - DNA - based, non-invasive colorectal cancer screening test.

Student self service (e.g., self registration on instructor - led training), training workflow (e.g., user notification, manager approval, wait list management), the provision of online learning (e.g., computer - based training, read & understand), online assessment, management of continuous professional education (CPE), collaborative learning (e.g., application sharing, discussion threads), and training resource management (e.g., instructors, facilities, equipment), are all dimensions to Learning Management Systems.

A cost recovery plan offered Thursday to the Commission on Teacher Credentialing calls for universities and other teacher training institutions to pay $ 1,600 for an initial application approval and a similar amount for new program evaluation.

Two other schools, Cape Fear Preparatory Academy (New Hanover) and Pine Springs Preparatory Academy (Wake), were recommended for approval by the Charter School Advisory Board (CSAB), which is tasked with reviewing applications and advising the State Board of Education on which are worthy of opening.

Of the applications submitted for external review, nine of the 26 evaluated (37 percent) met the 85 percent cut score requirement and will proceed to the next step in the approval process, an interview with TEA Charter Division staff and members of the Texas State Board of Education (SBOE) Committee on School Initiatives, held during the week of May 8 - 11.

Some of the most interesting items scheduled to be discussed and / or voted on at Tuesday's monthly Board meeting are expedited removal of teachers accused of misconduct, the use of student achievement to evaluate teachers, and Board approval for large grant applications.

Meanwhile, Save Our Schools and state legislators on both sides of the aisle, wary of charters in good school systems, are trying to push through a variety of bills that would increase transparency in charter schools and subject charter - school applications to a local approval before the applicants could seek DOE approval.

This report, from Self - Help, The A. J. Fletcher Foundation, and Public Impact, reflects their thoughts on policies, practices, and outcomes related to the state's charter application and approval process, and the oversight and measurement of charter school performance.

(e) The board shall establish the information needed in an application for the approval of a charter school; provided that the application shall include, but not be limited to, a description of: (i) the mission, purpose, innovation and specialized focus of the proposed charter school; (ii) the innovative methods to be used in the charter school and how they differ from the district or districts from which the charter school is expected to enroll students; (iii) the organization of the school by ages of students or grades to be taught, an estimate of the total enrollment of the school and the district or districts from which the school will enroll students; (iv) the method for admission to the charter school; (v) the educational program, instructional methodology and services to be offered to students, including research on how the proposed program may improve the academic performance of the subgroups listed in the recruitment and retention plan; (vi) the school's capacity to address the particular needs of limited English - proficient students, if applicable, to learn English and learn content matter, including the employment of staff that meets the criteria established by the department; (vii) how the school shall involve parents as partners in the education of their children; (viii) the school governance and bylaws; (ix) a proposed arrangement or contract with an organization that shall manage or operate the school, including any proposed or agreed upon payments to such organization; (x) the financial plan for the operation of the school; (xi) the provision of school facilities and pupil transportation; (xii) the number and qualifications of teachers and administrators to be employed; (xiii) procedures for evaluation and professional development for teachers and administrators; (xiv) a statement of equal educational opportunity which shall state that charter schools shall be open to all students, on a space available basis, and shall not discriminate on the basis of race, color, national origin, creed, sex, gender identity, ethnicity, sexual orientation, mental or physical disability, age, ancestry, athletic performance, special need, proficiency in the English language or academic achievement; (xv) a student recruitment and retention plan, including deliberate, specific strategies the school will use to ensure the provision of equal educational opportunity as stated in clause (xiv) and to attract, enroll and retain a student population that, when compared to students in similar grades in schools from which the charter school is expected to enroll students, contains a comparable academic and demographic profile; and (xvi) plans for disseminating successes and innovations of the charter school to other non-charter public schools.

Subject: 2017 History — Social Science Instructional Materials Adoption: Approval of the Schedule of Significant Events (Timeline) and the Application to Serve on the Review Panel (Application).

An invitation to submit an application for credit assistance does not guarantee the DOT's approval, which will remain subject to evaluation, based on all of the TIFIA statutory evaluation criteria, and the successful negotiation of terms and conditions acceptable to the Secretary.

An invitation to submit an application for credit assistance does not guarantee the DOT's approval, which will remain subject to evaluation, based on all of the statutory evaluation criteria, and the successful negotiation of terms and conditions acceptable to the Secretary.

On March 31, 2015, Delta and Aeromexico filed a joint application requesting approval of and antitrust immunity for alliance agreements covering routes between the U.S. and Mexico.

On June 11, 2015, American Airlines, Inc. (American) and Qantas Airways Limited (Qantas) filed a joint application requesting approval of and antitrust immunity for alliance agreements covering foreign air transportation between North America and Australia / New Zealand.

To apply for financing just bring your down payment and proof of income or fill out our Online Credit Application to get started on your approval.

Apart from eBooks, digital magazines flourish on mobile application and the number of downloads are rapidly gaining traction and approval from subscribers.

Approval is based on your answers to the questions on the application and information we obtain from other sources.

But the amount of income will be disregarded and only the amount you state on your application will be taken into account at the time of loan approval.

This implies that the loan approval and terms will be determined taking into account the income amount that you state to have on your application instead of the one you can prove by providing the proper documentation.

The rest of the fringe benefits depend on whether or not you are approved for a Visa Signature or Visa Platinum version of the card, which will be determined upon application and approval.