Sentences with phrase «on subsequent submissions»

In line with its reputation as a responsive exchange, the CSX commits to provide initial comments within five business days and three business days on subsequent submissions.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

The ensuing controversies have occasionally necessitated the submission of carefully crafted «corrections» at a subsequent general assembly, but even then the reliance on legislative procedure prevails.

We make submissions to the UN Committee on the Rights of the Child, which has repeatedly called on the UK Government to fully implement the International Code of Marketing of Breastmilk Substitutes and subsequent, relevant Resolutions in the UK, acknowledging that violations of these measures are «commonplace».

On the second and any subsequent pages of the submission, create a header and include your REAL LAST NAME, hyphen, and one or two keywords from your title on the right hand side of the pagOn the second and any subsequent pages of the submission, create a header and include your REAL LAST NAME, hyphen, and one or two keywords from your title on the right hand side of the pagon the right hand side of the page.

By submission for jurying, artists whose submissions are chosen for the exhibition grant The Center for Fine Art Photography the right to use their images for the purpose of promoting the artist, promoting the Center's programs, promoting exhibitions and subsequent display on the Center's website of current and past exhibitions.

By submission for jurying, artists whose submissions are chosen for the exhibition grant The Center for Fine Art Photography the right to use their images for the purpose of promoting exhibitions, promoting the Center's programs, promoting the artist and subsequent display on the Center's website of current and past exhibitions.

Subsequent to my original September 27, 2009 post, I never employed or even illustrated Scenario A in any presentation or blog article, other than an incidental use in a May 15, 2012 post where I ironically observed that a Yamal chronology incorporating fresh data from Hantemirov was remarkably similar to Scenario B. My position on Esper's Polar Urals version has been similar: that the inconsistency between proxies need to be reconciled before either can be relied upon, a position that I expressed in my submission to Muir Russell as follows:

Submissions of melt pond fraction, ice thickness, and any other sea ice parameter based on early - season data that could contribute to a status summary of pre-season conditions and help inform subsequent contributions to the regular SIO monthly report.

Pretty well as bad was Pearce's subsequent report on Jones» appearance before the parliamentary committee in which he claimed the committee didn't ask the questions it should have done and quoted with approval from the Institute of Physics submission.

Additionally, in my e-mail submission with the 18 page packet of backup documentation submitted on 7/7/11, I asked that Mondial promptly advise if it required any additional information and received no response to that email or subsequent emails or phone calls.

This short submission focuses on ensuring that children being raised in family and friends care are considered within any subsequent bursary scheme.