Sentences with phrase «earlier approval of»

Specifically, the process allows early approval of a drug to treat a serious or life - threatening disease based on clinical data.

Tell them you oppose early approval of the administration's priority actions (feel free to pick out specific actions you do not think should be considered for early approval, or to make a blanket statement that you oppose early approval of all identified priority actions).

Not exact matches

«That is going to cause turbo acceleration of the income, because that is 56 percent of the market in the biggest territory and that will have a massive impact on sales from 2019,» de Winkel said, adding that a U.S. approval could come early next year.

Stella Service is one of the early leaders in this space, trying to become the «Good Housekeeping» seal of approval for e-commerce and other sites.

In early January, Ant Financial, the electronics payment affiliate of China's Alibaba Group, and MoneyGram, a Texas - based money transfer company, announced that it had been forced to abandon a proposed deal after failing to win approval from the Committee on Foreign Investment in the United States (CFIUS), a congressional panel that reviews foreign purchases of American companies.

Lawmakers are calling for a deeper look into of HNA Group's pending and past takeovers of American companies, which could result in repealing the approval of earlier deals.

A month earlier drugmaker ICN Pharmaceuticals actually pleaded guilty to one count of criminal fraud for intentionally misleading investors — over many years, it now seems — about the FDA approval status of its flagship drug, ribavirin.

That led to an earlier Food and Drug Administration (FDA) approval for Keytruda than Opdivo in 2014 since the former was a more targeted therapy; but it also left Merck with a smaller slice of the market.

Once the final results of those studies are analyzed this spring — and the early evidence has been encouraging — the challenge will be to get FDA approval for human trials and then bring the treatment to market.

McCabe was forced out of the FBI earlier this year amid an internal investigation by the Office of Inspector General into his approval of unauthorized disclosures to the media in October 2016 about the bureau's Hillary Clinton email investigation.

Michigan's state legislature is expected to give final approval as early as Tuesday to new laws making it a «right - to - work» state despite protests from thousands of unionized workers.

Microsoft filed for EU approval earlier this month, and hopes for the transaction to close prior to the end of 2016.

However, given the slow pace of commercial drone approval in the U.S., is DreamHammer too early to market?

The poll's timing was favorable to Johnson, with Trump posting historically low job - approval ratings for the earliest part of his presidency.

Early in the decade the company had been dogged by R&D failures, most notably of Vanlev, a high - profile hypertension drug that had been hailed as a can't - miss blockbuster but then fell short of even getting FDA approval.

Shares of Clovis Oncology closed up 8.82 percent Monday as the company received early approval for its advanced ovarian cancer drug Rubraca (rucaparib).

McCabe was forced out of the FBI earlier this year amid an internal investigation by the Office of Inspector General into his approval of unauthorized disclosures to the media in October 2016 about the bureau's Hillary Clinton email probe.

The Japan Times wrote that the exchange's initial decision to list these coins had been one of several reasons that the FSA had not yet granted it official approval, signaling that the agency's apprehensions around privacy coins date back to March, if not earlier.

All of the accords still require approval from Argentina's Congress, which also needs to repeal a law that currently prevents the country from proposing terms to the holdouts that are better than those the nation offered creditors in earlier restructurings.

With the OMB's approval of the Labor Department's 18 - month fiduciary rule delay having most assuredly kicked in (approval was anticipated within a week or two at press time in early November), should advisors put the brakes on compliance?

Conversion of preferred stock occurs automatically and immediately upon the earlier to occur of the closing of a firm commitment underwritten public offering pursuant to an effective registration statement filed covering the offer and sale of common stock in which (i) the aggregate public offering price equals or exceeds $ 25 million, (ii) with respect to the Series F convertible preferred stock only, the public offer price per share of which is not less than one times the original issue price of the Series F convertible preferred stock, (iii) with respect to the Series E convertible preferred stock only, the public offer price per share of which is not less than one times the original issue price of the Series E convertible preferred stock and (iv) with respect to the Series D convertible preferred stock only, the initial public offering price per share of which is not less than two times the original price of preferred stock, or the date specified by holders of at least 60 % of the then outstanding Series B convertible preferred stock, Series C convertible preferred stock, Series D convertible preferred stock, Series E convertible preferred stock, Series F convertible preferred stock and Series G convertible preferred stock, provided however, that in the event that the holders of at least 65 % of the then outstanding shares of holders Series G convertible preferred stock, at least a majority of the then outstanding shares of Series F convertible preferred stock or at least of 65 % of the then outstanding share of Series E convertible preferred stock do not consent or agree to the conversion, conversion shall not be effective to any shares of the relevant series of Series G convertible preferred stock, Series F convertible preferred stock or Series E convertible preferred stock for which the approval threshold was not achieved.

The deal requires the approval of federal regulators and is expected to close by early in the second quarter.

This widening in the gap between fixed and variable housing rates is likely to have contributed to the pick - up in the proportion of borrowers choosing to take out fixed - rate housing loans: in November 2004, the latest available data, 11 per cent of new owner - occupier housing loan approvals were at fixed rates, up from 7 per cent three months earlier and the highest share since the beginning of 2004, which followed a period of monetary policy tightening (Graph 45).

In early November 2016, the Company received approval to commence its drill program under Division 37 guidelines by the Oregon Department of Geology and Mineral Industries («DOGAMI»).

In a statement issued earlier this month, U.S. Food and Drug Administration Commissioner Scott Gottlieb said the agency had given B. Braun and Baxter temporary approval to import products from some of their overseas operations, including allowing Baxter to import product from Brazil.

To date, the rate of growth in building approvals looks more like the moderately paced upturn in housing in the early 1990s, than the extremely rapid increases of the late 1980s cycle.

In recent months, as discussed in the section on Domestic Economic Activity above, housing loan approvals have stabilised after the strong growth recorded earlier, but they remain at a high enough level to generate continued strong growth in the value of loans outstanding.

The strong growth in household borrowing looks likely to continue at least into the early months of 2004, with housing loan approvals remaining at a very high level, despite falling in November for the first time in more than a year.

Over the past three months, the value of total loan approvals has risen by 12 per cent to be 31 per cent higher than a year earlier.

It has high hopes for approvals of earlier use of Ibrance and the prostate cancer drug Xtandi that would boost sales.

Shares of Staples, Inc. (NASDAQ: SPLS) were trading higher by 0.18 percent early Tuesday morning after the New York Post reported the company is close to gaining FTC approval for its pending acquisition of Office Depot Inc (NASDAQ: ODP).

After increasing strongly during much of 1997, loan approvals for housing appeared to level out in the early months of this year, before showing a strong further rise in June (Graph 15).

Whereas aristocratic Athenian opinion probably had a strong role in «promoting» the Iliad as worthy of recitation, the Zombies» earlier hit singles, the ones that allowed them to even record Odessey and Oracle, were hits entirely due to the adolescent many's approval.

Although the term Modernist was strictly avoided, the Vatican II Council did initiate a number of moves to which the earlier Modernists would have given hearty approval.

Dairy producers in India earlier too had a brush with Russian bureaucracy when approval to reports on the quality of Indian products was delayed.

ALEC also said early this week an independent audit is to be conducted by an Australian Government Approved Auditor and pending approval, the operational start - up of the facility will be monitored to ensure ESCAS compliance.

Lord earlier ruled out Murray Goulburn because it was «carrying too much debt» and because of concerns about a lengthy Australian Competition Tribunal approval process.

Privately - owned Victorian company ViPlus Dairy trumpeted in early December that it was the first Australian manufacturer of milk powder to receive China FDA approval to keep selling its products in the China market.

Now that General Motors has given the Wankel its seal of approval by indicating that some versions of its Vega subcompact will be sold with rotary engines as early as Spring 1974, there is little question that automobiles of every size and nationality will be humming along under «R.C. Power» by the end of the decade.

«The R&A and USGA announce final approval for Rule 14 - b that prohibits the use of anchored strokes,» the R&A website announced early Tuesday morning.

Where he will fit into the crowded and incredibly skilled Juventus midfield still remains to be seen, but Marotta and the rest of the Juve front office clearly found the reported private medical exams that took place earlier this week to be approval - worthy.

But its too early to say if he is the right fit for Wenger but who ever replaces Wenger will have his stamp of approval all over.

Park officials had hoped construction could be finished by Memorial Day, but the city, which is issuing the grant, will not give final approval of it until early summer, forcing a delay.

There were earlier reports that two have had the approval of their nominations suspended due to some issues the committee deemed necessary for probing.

Fruscher ominously notes that a «much more significant downsizing of our entire workforce lies ahead,» but the OTB is awaiting legislative approval for an early - retirement incentive program and a joint effort with the union that represents most of the operation's workforce in accordance with a MOU.

Members of the Steering Committee are expected to review recommendations made earlier by the technical advisors of the First Ladies of Member States which was chaired by Mrs. Akufo — Addo and endorse them for further discussion at the General Assembly Session of OAFLA for approval.

Cuomo outlined earlier in the day what he would like from a special session of the Legislature: approval of $ 2 billion in affordable housing, procurement reform and the funding of a hate crimes task force.

Already in the early 2000s, Iranian legislators managed to get the council's approval for the controversial and progressive set of harm reduction measures.

Gov. Andrew Cuomo's 37 percent approval rating in a poll earlier this month can in part be attributed to the spate of corruption scandals to plague the Capital, former Gov. David Paterson on Monday said.

A Quinnipiac poll released earlier this month found Stringer has the highest approval rating of the trio.