Not exact matches
We are «concerned that these major findings are presented ambiguously within the Executive Summary and are inconsistent
with the observations,
data, and levels of
uncertainty presented and discussed
in the body of the draft Assessment Report,» states the review.
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.
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.
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).
Examples of these risks,
uncertainties and other factors include, but are not limited to the impact of: adverse general economic and related factors, such as fluctuating or increasing levels of unemployment, underemployment and the volatility of fuel prices, declines
in the securities and real estate markets, and perceptions of these conditions that decrease the level of disposable income of consumers or consumer confidence; adverse events impacting the security of travel, such as terrorist acts, armed conflict and threats thereof, acts of piracy, and other international events; the risks and increased costs associated
with operating internationally; our expansion into and investments
in new markets; breaches
in data security or other disturbances to our information technology and other networks; the spread of epidemics and viral outbreaks; adverse incidents involving cruise ships; changes
in fuel prices and / or other cruise operating costs; any impairment of our tradenames or goodwill; our hedging strategies; our inability to obtain adequate insurance coverage; our substantial indebtedness, including the ability to raise additional capital to fund our operations, and to generate the necessary amount of cash to service our existing debt; restrictions
in the agreements governing our indebtedness that limit our flexibility
in operating our business; the significant portion of our assets pledged as collateral under our existing debt agreements and the ability of our creditors to accelerate the repayment of our indebtedness; volatility and disruptions
in the global credit and financial markets, which may adversely affect our ability to borrow and could increase our counterparty credit risks, including those under our credit facilities, derivatives, contingent obligations, insurance contracts and new ship progress payment guarantees; fluctuations
in foreign currency exchange rates; overcapacity
in key markets or globally; our inability to recruit or retain qualified personnel or the loss of key personnel; future changes relating to how external distribution channels sell and market our cruises; our reliance on third parties to provide hotel management services to certain ships and certain other services; delays
in our shipbuilding program and ship repairs, maintenance and refurbishments; future increases
in the price of, or major changes or reduction
in, commercial airline services; seasonal variations
in passenger fare rates and occupancy levels at different times of the year; our ability to keep pace
with developments
in technology; amendments to our collective bargaining agreements for crew members and other employee relation issues; the continued availability of attractive port destinations; pending or threatened litigation, investigations and enforcement actions; changes involving the tax and environmental regulatory regimes
in which we operate; and other factors set forth under «Risk Factors»
in our most recently filed Annual Report on Form 10 - K and subsequent filings by the Company
with the Securities and Exchange Commission.
With the increase
in scientific
data comes a decrease
in uncertainty about how the universe works.
Such a notion as emergence, for example, which is closely allied
with the principle of indeterminacy and
uncertainty and which was later to develop
in physics, actually assumed more credence
in physics before it took root
in biology and psychology; yet it has more significant implications for the
data of the organic and social sciences than for physics.
But this reckoning is burdened
with still another
uncertainty, apart from the question whether the
data in the Gospel of John reflect the correct chronology.
Scientists unaffiliated
with the study said it highlights the
uncertainty in data released by the Chinese government.
However, there are large
uncertainties in the estimate and it appears it is not compatible
with the satellite «handshake»
data transmitted from the aircraft, which is currently considered the most reliable source of information.
A new integrated climate model developed by Oak Ridge National Laboratory and other institutions is designed to reduce
uncertainties in future climate predictions as it bridges Earth systems
with energy and economic models and large - scale human impact
data.
A new integrated computational climate model developed to reduce
uncertainties in future climate predictions marks the first successful attempt to bridge Earth systems
with energy and economic models and large - scale human impact
data.
I am disturbed
with the quoted
uncertainty in the Schmittner paper,
in light of the significant discrepancies between the sensitivity extracted from the ocean and the land
data (their figure 3).
The
uncertainties associated
with reconstructing hemispheric mean or global mean temperatures from these
data increase substantially backward
in time through this period and are not yet fully quantified.
The study also uses survey
data from developers to gauge the effect of timeline
uncertainty in each municipality,
with responses measured on a five - point scale from (1.0) «encourages development» to (5.0) «would not pursue development due to uncertain approval timelines.»
Your reference to the Paleo is understood, however as
with models there must be some inherent
uncertainty in the different methodologies (particularly the transient constraints as recent
data should also be accounted for
in them).
Boris (# 121) points out that contrarians are more than happy to accept the trends calculated for a few distant planets if it obscures the cause of the trends seen on Earth — even though the
data which we have on those trends have a great deal more
uncertainty associated
with them (see Nicholar L's # 88), and as an explanation
in terms of solar variability is not credible (ibid.)
HadSST3 not only greatly expands the amount of raw
data processed, it makes some important improvements
in how the
uncertainties are dealt
with and has a more Bayesian probabilistic treatment of the necessary bias corrections.
I suppose that if all
uncertainties are resolved
in the direction of lower risk, we just might get away
with BAU for the next few decades without a complete disaster (though continued sea level rise, ocean acidification and 2 degrees Celsius actually sound pretty risky to me, and the risk that there are other factors
in play seems to be reinforced by paleo
data on glacial - interglacial transitions).
I recently researched causes of subsidence
in Bangladesh (Brown and Nicholls 2015) and struggled
with the
uncertainties,
data errors, and
in some cases, poor science when recording rates of subsidence.
With complete
data these methods are equivalent, but not quite when there is missing
data, though the
uncertainties in the trend are more straightforward
in the first case.
The Siegel and Franz letter simply emphasizes the new challenges associated
with measuring changes
in phytoplankton biomass
in the satellite remote sensing paradigm, where sampling frequency is much improved, but limited time - series duration and
uncertainties associated
with instrument calibration and
data processing algorithms complicate the interpretation.
When faced
with durable
uncertainty on many fronts —
in the modeling of the atmosphere,
in data delineating past climate changes, and more — pushing ever harder to boost clarity may be scientifically important but is not likely to be very relevant outside a small circle of theorists.
In their rejoinder MW claim they didn't agree with reducing the data set to 59 as follows: «the application of ad hoc methods to screen and exclude data increases model uncertainty in ways that are unmeasurable and uncorrectable.&raqu
In their rejoinder MW claim they didn't agree
with reducing the
data set to 59 as follows: «the application of ad hoc methods to screen and exclude
data increases model
uncertainty in ways that are unmeasurable and uncorrectable.&raqu
in ways that are unmeasurable and uncorrectable.»
The IPCC range, on the other hand, encompasses the overall
uncertainty across a very large number of studies, using different methods all
with their own potential biases and problems (e.g., resulting from biases
in proxy
data used as constraints on past temperature changes, etc.) There is a number of single studies on climate sensitivity that have statistical
uncertainties as small as Cox et al., yet different best estimates — some higher than the classic 3 °C, some lower.
Diversity # 183, could be useful but the problem
with «the generally accepted body of theory relating to global warming» is not that it is either wrong or incomplete, but that operational results based on it will suffer from
uncertainty, i.e., imprecision, due to the way that
in the theoretical framework, precision is propagated from
data to results.
In the interview,
with Andy Balaskovitz, I described the value of having a public more attuned to how science works — that new knowledge is what's left over after peers chew on each others»
data and analysis, and that argument and
uncertainty are normal, that science is a journey, not a set of facts:
Regarding the Hockey Stick of IPCC 2001 evidence now indicates,
in my view, that an IPCC Lead Author working
with a small cohort of scientists, misrepresented the temperature record of the past 1000 years by (a) promoting his own result as the best estimate, (b) neglecting studies that contradicted his, and (c) amputating another's result so as to eliminate conflicting
data and limit any serious attempt to expose the real
uncertainties of these
data.
It's been a long time since the IPCC scientists actually looked at reality and dealt
with the messy stuff
in the trenches, like
data set
uncertainty.
Both the reporting Parties and the review teams noted problems
with the reliability and comparability of estimates due to the degree of scientific
uncertainty and difficulties
in data generation, and
in particular the variation
in data availability amongst Parties.
Let's compute the warming rate using each 30 - year segment of the Berkeley
data, together
with the estimated
uncertainty in that rate, using an ARMA (1,1) model for the noise just to feed the «
uncertainty monster.»
Their tactics and fallacies include ignoring or distorting mainstream scientific results, cherry - picking
data and falsely generalizing, bringing up irrelevant red - herring arguments, demanding unachievable «precision» from mainstream science
with the motif «if you don't understand this detail you don't understand anything», overemphasizing and mischaracterizing
uncertainties in mainstream science, engaging
in polemics and prosecutorial - lawyer Swift - Boat - like attacks on science - and lately even scientists, attacking the usual scientific process, misrepresenting legitimate scientific debate as «no consensus», and overemphasizing details of little significance.
There are many different actors
with various levels of technical expertise, meaning that there is a lot of variation
in the way they understand
uncertainty of scientific
data.
But the report states that «
uncertainties associated
with the various factors and methodologies used
in data set development make 2005 statistically indistinguishable from 1998.»
Previous large natural oscillations are important to examine: however, 1) our
data isn't as good
with regards to external forcings or to historical temperatures, making attribution more difficult, 2) to the extent that we have solar and volcanic
data, and paleoclimate temperature records, they are indeed fairly consistent
with each other within their respective
uncertainties, and 3) most mechanisms of internal variability would have different fingerprints: eg, shifting of warmth from the oceans to the atmosphere (but we see warming
in both), or simultaneous warming of the troposphere and stratosphere, or shifts
in global temperature associated
with major ocean current shifts which for the most part haven't been seen.
However, early estimates from the Global Carbon Project (GCP) using preliminary
data suggest that this is likely to change
in 2017
with global emissions set to grow by around 2 %, albeit
with some
uncertainties.
To elaborate slightly on my above point, the cause / effect relationship between CO2 and temperature derived from
data spanning more than 400 million years, and operating within
uncertainty margins that can be quantified
with reasonable probability requires the existence of a prominent CO2 signal
in the record of the past half century.
If we do this
with the
data here, we obtain an ECS that likely lies within the blue band: between 3.1 and 4.2 K,
with a most likely value of 3.7 K. Simply looking at the scatter of the 29 models
in this plot indicates that this
uncertainty band is too narrow.
I would have liked to see mention of
uncertainty that inherent
in examining short term
data, whether the end points used introduces an element of bias, whether the «pause» is on a much higher plateau of warming than
in the past, whether decadel cycles
in ocean heat displacement may have interacted
with the the known minimum levels of solar activity (not modelled) to cause this «pause».
The more
uncertainty in the trends, the more likely the
data is compatible
with a continuation of pre-1997 warming.
This design then creates issues when grid cells have few or no
data points, and a great deal of work is needed to deal
with the
uncertainties caused by the cell design, as described
in the papers cited
in this thread.
Wrestling
with uncertainty in this
data set is a huge job.
As
with any calculation system, Footprint accounts are subject to
uncertainty in source
data, calculation parameters, and methodological decisions.
The
uncertainties associated
with reconstructing hemispheric mean or global mean temperatures from these
data increase substantially backward
in time through this period and are not yet fully quantified.
It would be interesting to see Mann's analysis run
with observational
data properly adjusted for undercount and short - duration storms, or at a minimum considering these factors as part of the
uncertainties in the analysis.
Many physical modelers, and especially climate modelers, seems to think that as long as their models are «science - based» then there is no need to account for
uncertainty in their outputs, notwithstanding that the model parameters are tuned
with data, and that aspects of these models are likely to be ill posed (highly sensitive to small perturbations
in the values assigned to parameters).
Moreover, to cover the full range of
uncertainty in the historical volcanic eruption
data, we even try the case
with 3 times the best estimate of volcanic forcing.
Horatio has discovered that (lo and behold) a «Curry Cliff Quotes» site already exists (ThinkExist.com) though Horatio must admit that the Judith Curry who is quoted there may be (sure seems like) a different one than the one who has been doing the blog shows recently (quoted at CurryQuotes) Here's an example of the kind of thing «ThinkExist Judith Curry» (aka «Thinking Judith Curry») says: «Even
with imperfect
data and some
uncertainty, it's hard to imagine what kind of errors might be
in the
data set to give you a long - term trend.»
No
data in science is ever exact — all of it comes
with uncertainties, the possibility of bias, and more.
GFDL NOAA (Msadek et al.), 4.82 (4.33 - 5.23), Modeling Our prediction for the September - averaged Arctic sea ice extent is 4.82 million square kilometers,
with an
uncertainty range going between 4.33 and 5.23 million km2 Our estimate is based on the GFDL CM2.1 ensemble forecast system
in which both the ocean and atmosphere are initialized on August 1 using a coupled
data assimilation system.