Sentences with phrase «approval of the application of»

The first is for the approval of an application of a credit card, loan, or lease.

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.

More than 40,000 companies submitted H - 1B visa applications in fiscal year 2016 and the top 20 sponsors account for 37 % of all visa approvals.

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.

My advice is to have a central place where such requests are made (like the HR department) and have it keep track of approvals and denials — so it can ensure fair application of program guidelines.

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.

Federal Communications Commission Chairman Ajit Pai proposed the approval of an application by SpaceX to provide...

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).»

China's is the last of nine approvals needed and has already caused the companies to withdraw and refile their application to buy more time.

The borrower will be presented with an Application Disclosure and an Approval Disclosure within the application process before they accept the terms and conditions of Application Disclosure and an Approval Disclosure within the application process before they accept the terms and conditions of application process before they accept the terms and conditions of their loan.

The borrower will be presented with an Application Disclosure and an Approval Disclosure within the application process before they accept the terms and conditions oApplication Disclosure and an Approval Disclosure within the application process before they accept the terms and conditions oapplication process before they accept the terms and conditions of the loan.

Other approvals came as a result of state - by - state applications.

The Secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the Secretary of such material threat medical countermeasure application.

The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application.

Our upfront honest approach and fast turn around results in a higher number of application approvals.

Our sales team handles all application origination and works with our underwriting department to provide same day approvals leading to the funding of the required equipment.

Pre-qualification often isn't as intense as a loan application since it requires only basic financial information, and it can tell you your chances of loan approval, how much funding you could qualify for, as well as offer other financing options that might be a good fit for your situation.

Increase credit card application approval chances with the help of these tips.

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

According to Department of Justice policy, an application for a search warrant of a lawyer's office such as this is so serious that it usually requires approval of either the U.S. attorney for the district, or the assistant attorney general.

You'll learn how you can increase your chances of approval and how to save time during the application process.

For example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorization.

When it comes to mortgage approval, much depends on the borrower's total debt load at the time of application, as well as the payment history.

* Tocqueville Trust Services, a Division of New York Private Trust, a Delaware Company ** Mortgage and credit services, which are subject to application and credit approval, are provided by BNY Mellon, N.A. member FDIC, and a wholly owned subsidiary of The Bank of New York Mellon Corporation

During the pre-approval process, your lender will take a complete loan application which includes performing an income and asset verification, and he will account for specific loan traits which may affect your final approval such as your personal credit scores, any required child support payments, and the availability of a co-signer, as examples.

Only 34 percent of buyers felt the mortgage application and approval process was somewhat or much more difficult than they expected.

Guaranteed approval usually means that lenders accept applications from clients with a history of consumer proposals, bankruptcies, credit counseling, seriously delinquent accounts, and past collections.

Maintaining timely approvals for new drugs is vital for drugmakers, since there are dozens of drug approval applications awaiting assessment by the EU regulator in the next few years.

By having a line of credit for your business, you don't waste valuable time going through an application and approval process each time you need to borrow more money.

A fraud alert may also delay the approval of credit applications you make, as lenders verify your identity.

After your preliminary approval is issued, your mortgage lender will ask you to provide paperwork which proves the information you've shared as part of your application.

Going forward, changes will be made to funding agreements, application forms and approval letters for any funding doled out by the Heritage Department and the Canada Council of the Arts, requiring recipients to explicitly commit to providing a harassment - free workplace.

All loans require the submission of a loan application and are subject to credit approval and property review.

The case is In the Matter of the Application of TransCanada Keystone Pipeline LP for Route Approval of the Keystone XL Pipeline Project, 0p - 0003, Nebraska Public Service Commission (Lincoln).

«Subject to Health Canada's approval of Shoppers Drug Mart's application to be a licensed producer, under the terms of the agreement the Company will supply Shoppers Drug Mart with Aphria - branded medical cannabis products,» a release from Aphria said.

Remember that no personal loan application is guaranteed, so use the guide above to ensure you're giving yourself the best chance of approval you can.

While the CFDA works through a backlog of applications around 300 files thick, BeiGene will begin marketing popular therapies from Celgene (NASDAQ: CELG) that have already earned the Agency's approval.

What's even dumber is the approval of the application.

Many companies assess a fee just to submit an application, with no guarantee of approval.

Submit application and documentation of requirements to ACF for approval by: E-mail (preferred): [email protected] or Fax: [phone] or Mail to: American Culinary Federation, Inc., Attn: Certification Department, 180 Center Place Way, St. Augustine, FL 32095.

RESIST Agrochemical TNCs together with the All UP Academic Employees Union and NNARA — Youth UP Manila conducted a Round Table Discussion with civil society organizations regarding the imminent approval of Golden Rice application for direct use and open field testing.

«As a result, approval for Moon Lake's foreign investment application is the first to be subject to new conditions requiring it to comply with Australian taxation law...» Mr Morrison said, «A breach of these conditions could result in prosecution, fines and potentially divestment of the asset.»

Submit application and documentation of requirements to ACF for approval by: E-mail (preferred): [email protected] Fax: [phone] Mail to: American Culinary Federation, Inc..

Laguna, Philippines - The recent release of Food Standards Australia New Zealand (FSANZ) approval report of International Rice Research Institute (IRRI) application for a Golden Rice «safety stamp» and trade liability clearance have garnered negative reactions and widespread critique.

5 February 2018 / In 2016, the International Rice Research Institute (IRRI) filed an application at the Food Standards Australia New Zealand (FSANZ) for the market approval of food derived from so - called Golden Rice (GR2) for import.

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»)

When unlabeled bottled wine is transferred among two or more bonded wine premises for aging or labeling, the bottler must provide a copy of the approved Application For And Certification / Exemption of Label / Bottle Approval (COLA) TTB Form 5100.31 under which the wine was bottled.

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-.