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Some analyst comments. Buying Opportunity, Overdone seems to be the theme.
B I O T E C H
@_B_I_O_T_E_C_H_
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58m
Jefferies $AMRN Adcom Panel Now And Minor Delay ... Likely A Buying Oppt'y
4
B I O T E C H
@_B_I_O_T_E_C_H_
·
59m
Cantor $AMRN No Heartbreak Here, Negative Reaction To AdCom Is Overdone, In Our View
4
B I O T E C H
@_B_I_O_T_E_C_H_
·
1h
STIFL $AMRN FDA Plans To Hold Adcom; We Are Buying The Weakness As Vascepa's sNDA Very Much Approvable, In Our View
We are going with Pizza and Beer tonight. I'll take my Vascepa when I am done. We know how good this drug is and it will work out in the end.
FDA wanted Amarin to wait for Federal Register notice.
There will be analyst questions where there may be some additional discussion.
If you have extra cash available, support the stock.
Hold tight. It will be back up before Christmas. I have been saying all along patience but they are definitely testing us.
There are still people over on twitter calling this 'fish oil". Some are very slow to learn. Patience will continue to pay off here. It will just not happen in the time that you think.
Thanks for your work on this. It should be a very interesting fall.
You did say cool. I just read it as cold.
Cold storage, where did you get that from?
"Bhatt said on a tv interview that he asked Amrn if they could give him more time but they said they didnt have the money for more trails and needed the info last sept"
Can I get a link for that? I have listened to most if not all of his interviews and do not remember this.
I am sure the Baker Bros do not need your advice. If they have an issue with the CEO they will either take it up with him or the BOD or they will sell their shares. That is how adults with money behave.
It says they are closed right at the top of the screenprint. It says "July Closed ".
You should take that down. It could get you sued.
I almost feel like there is an upgrade out there today, it just hasn't been made public.
There was an approval yesterday of another drug. It had a priority review PDUFA date of today. So, at this point I would expect an on-time PDUFA approval. If it comes early great.
That is great news. With the information currently embargoed it makes me wonder whether it will be part of a Press Release when the FDA approves Vascepa. September is not that far away.
This is all about timing. You and JL are looking at a point in time. The high and the most recent low. Overall I am sure you are in great shape. Your shares would have been below this level two months ago. It is easy to second guess when it is low but there is always next week.
TerraPharma is the best. Everyone should follow him on twitter.
I was also looking at a weekly chart last night. The stock was lower back in June. Not so long ago. Market cap would have been much lower. Short interest is still trying to lower this stock. Big money does not like that this is retail owned and they want JL's shares and they want them at a lower price. Either he (and others) will hold on until profits and stability occur or they will have fear and doubt take over and sell them.
With the large increase in share price last fall there may be some here who have two many eggs in one basket. No one CEO is going to do everything to the liking of someone that is nervous about how much money they have in one investment. To say that a CEO must step down when a retail investor has no idea what is going on behind the scenes is ridiculous. If someone owns too much stock they are going to get nervous and they need to look within themselves as to whether they can hang on. They should worry about their own house and not project their fear of their own stability on a message board.
JT now has an extra 400M in the bank and can use it as he and the Board sees fit. Either you have faith in the management or you don't. They company is in a position of strength to handle any downturn in stock price. Investors here should do the same. Some should not be on margin if they can't handle it. Next time the stock goes back up they may want to sell off their extra shares.
I personally am holdings and bought more shares on Friday. Analyst are still coming out and supporting this stock and it is going to be a good one in the long run. One analyst saying approval priced in is only one analyst. Other price targets are much higher. We know what we own. The science along with a growing sales staff, expanded label, improved managed care and DTC advertising will prevail. We damn near were profitable this past quarter. That's pretty good. It will happen soon enough. Patience.
Until we know what he is doing with the money you can't really say it was a bad move and it is clearly not illegal as you have implied.
It depends on what they do with this money. I wonder if they will buy the Mochida drug. It has to be a good one for AMRN has partnered with them on it.
From TerraPharma regarding new FAQ on Amarin website
TerraPharma
@TerraPharma1
·
19m
New FAQ from $AMRN. They will be adding a number of patents to the FDA's Orange Book after sNDA approval, including these granted patents: see pic
#orangebook #fda #vascepa #reduceit #icosapentethyl
FAQ here: (link: https://amarincorp.gcs-web.com/static-files/8fe11e30-56f6-402a-8765-e62ac8de6fd9) amarincorp.gcs-web.com/static-files/8…
It is always a long slog from the time a NDA/sNDA is submited and when it is approved. It looks like there are some here trying to create doubt. There is no AdCom, no CRLs, no manufacturing issues, just smooth sailing. The raise is going to get put to good use and the price manipulation is artificial. It will all be good by fall for those who have the faith and hold.
It is going to be fine. Everyone needs to hold tight and have a little patience. Revenue is growing and this will be a very profitable company soon enough.
Glad to see Amarin beefing up managed care area.
National Director Regional Accounts
Full Time
Management
Bedminster, NJ, US
4 days ago
Requisition ID : 1747
APPLY
Company Description:
Amarin Corporation plc (“Amarin”) is a rapidly growing pharmaceutical company developing and selling therapeutics to improve cardiovascular health. Amarin, a publicly traded company (NASDAQ: AMRN) with approximately 550 employees, is headquartered in Dublin, Ireland and has its US operations (Amarin Pharma Inc.) based in Central New Jersey. Amarin has successfully developed, registered and launched VASCEPA® in the U.S. market with a network of third-party companies aligned with Amarin to advance commercialization of VASCEPA® globally. In the U.S., VASCEPA® was launched in 2013 for its initial indication of as a treatment of Very High Triglycerides (i.e. patients with TG levels ≥ 500mg/dL).
In November 2018, unprecedented clinical results were announced from a landmark global cardiovascular outcomes study in which VASCEPA® was demonstrated significantly lower the risk of cardiovascular events on beyond the current standard of care for cholesterol management. This study was recognized as the top clinical result in 2018 by The New England Journal of Medicine. Amarin recently announced plans to increase the size of the U.S. sales force from 400 to 800 representatives and anticipates accelerated revenue growth from VASCEPA® based on the unprecedented results recently announced its outcomes study. Amarin plans to seek expanded labeling for VASCEPA® to reflect the results of this outcomes study, called the REDUCE-IT study. Amarin is a science driven company focused on improving patient care. It is truly an exciting time to join the Amarin team.
Position Description:
The company’s U.S. entity, Amarin Pharma Inc, is seeking a National Director, Regional Accounts (NDRA). The NDRA's primary responsibilities is to lead a team Regional Account Managers who are responsible for securing and maintaining profitable coverage (reimbursement) and access for Amarin Pharma Inc. products within regional payer, PBM and IDN accounts. The NDRA will also build and lead successful pull through campaigns in collaboration with Regional Sales Teams to maximize the impact of the coverage and access. Coverage and access goals will be achieved through contracting where necessary and non-contracting opportunities where possible, including successful pull-through of National contracts at the Regional client level. The National Director, Regional Accounts will ensure that the Regional Account Managers assess and diagnose the current business environment in each key account to gain and maintain targeted formulary access for Vascepa with profitable terms, as well as maximize the pull through of the access.
This is an exciting opportunity to be a part of a market expansion in a growing entrepreneurial-minded team-oriented environment, where sales performance and territory ownership are paramount. Amarin offers competitive base pay, quarterly incentive compensation, comprehensive employee benefits including stock options and auto allowance program.
Primary Objectives:
• Lead Regional Account Managers to leverage strong account management experience and strategic account planning to effectively penetrate accounts, develop an understanding of their needs, and negotiate and maintain profitable access for Amarin Pharma Inc. products
• Utilize strong business acumen, comprehensive account and industry knowledge, and financial modeling to ensure that the RAM team develops compelling proposals and negotiations strategies, as needed.
• Manages assigned Regional MCO, PBM and IDN accounts.
• Work closely with National Account Medical Affairs teams to demonstrate the clinical and economic value of Amarin Pharma Inc. products to Regional MCOs, PBMs, ACOs, IDNs and Health Systems.
• Works with other members of the Managed Care and Trade Leadership Team to develop overall contracting, access and pull-through strategies for Nation and Regional Account teams
• Ensures the RAM team builds effective pull through strategies and provides impactful pull through support for Sales teams that will drive plan performance, ensure contracts meet profitability targets and ultimately meet overall company sales objectives. Coordinates ongoing meetings to support sales pull through, messaging, and tools to drive utilization at plans
• Works with VP, Managed Care to develop and manage performance metrics and reporting for RAM team.
• Ensure that RAM team develops and implements effective business reviews of key accounts/marketplace on at least a quarterly basis with Area Sales Directors (ASD).
• Provide managed care training and issue resolution as needed.
Required Qualifications:
• Education/Training: Bachelor’s degree or equivalent experience.
• Must have a valid Drivers License
• Field based position with travel greater than 50% which will include overnight and some weekend travel
• Must be able to feely and frequently operate and travel by car, train/plane modes of transportation
Experience:
• Minimum 5 years of experience in Managed Care and 10 years’ experience in the Pharmaceutical Industry.
• Previous experience leading a team of Managed Care account managers: prior District Management and/or Account Team Leadership experience.
• Proven track record of leading teams and exceeding performance goals by developing and implementing effective pull through plans, including analytics and metrics to track success.
• Record of success working with a wide variety of Regional and Sub-national Managed Care customers, preferably within target accounts.
• Demonstrated ability to develop strong relationships with key decision makers in target accounts. Contracting and negotiation with MCOs, PBMs, IDNs and Health Systems with experience in cardiovascular or similar therapeutic area.
• Documented success working collaboratively and effectively with sales teams to execute pull through strategies that drive sales and in-turn, positively influence access decisions
• Demonstrated ability to work with sales teams to help them overcome access barriers, including barriers based on UM restrictions and/or patient out-of-pocket costs.
• Proven record of high ethical values and health care compliance.
Skills:
• Strong analytical skills and writing skills; contracting and negotiation
• Works as a team player; solid organizational skills with ability to meet tight deadlines
• Persuasive and influential with a strong ability to effectively lead without formal authority.
Wow your first post. Congratulations. No source for your realization, well done. No one would just realize something like this if they were not trying to create FUD. Mets fan is correct that the numbers will not be correct until much later, t will be 90 days after the 3rd quarter ends. You can do calculations to correct them if you were really interested. The secondaries were bought by institutions. Institutional ownership has gone up.
There are "preventive drug lists" in many types of plans. Once a drug is on the preventive drug lists it has a lower copay. Statins are an example. Once expanded label is done we need to get Vascepa included in the preventive drug lists. Hopefully this is something the managed care/lconsultants/lobbyist are working on. I have mentioned it to Amarin but have not had any response.
It is a good time to move to Florida, in October. It is brutally hot here in July and August. You might want to plan escape vacations to get away from the heat and humidity. The mountains of North Carolina or Switzerland work pretty well. .
Just my personal opinion and I am not picking on anyone but I think people should spend more time reading the SEC documents instead of just relying on this message board. I know it is not flashy or fun but it gives you the confidence to make decisions on your own and not just rely on the ebbs and flows of a message board.
It is in yesterday's 10-Q.
"In contrast, a three-year period of exclusivity under the Hatch-Waxman Amendments is generally granted for a drug product that contains an active moiety that has been previously approved, such as when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by the sponsor that were essential to approval of the application. Accordingly, we expect to receive three-year exclusivity in connection with any future regulatory approvals of Vascepa, such as an approval sought based on positive REDUCE-IT outcomes study results. Such three-year exclusivity protection precludes the FDA from approving a marketing application for an ANDA, a product candidate that the FDA views as having the same conditions of approval as Vascepa (for example, the same indication and/or other conditions of use), or a 505(b)(2) NDA submitted to the FDA with Vascepa as the reference product, for a period of three years from the date of FDA approval. The FDA may accept and commence review of such applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of patents at any time, subject to any prior four-year period pending from a grant of five-year exclusivity. This three-year form of exclusivity may also not prevent the FDA from approving an NDA that relies only on its own data to support the change or innovation."
I do not understand this board sometimes. Why would you reach out to IR to ask whether they still expect something when they have it included in their 10-q from yesterday? Do you really expect that something changed from yesterday?
I would not decide long term outcomes based on one day. Also, you might look at what happened in the overall market today.
Take a look at liguratide. Saxenda was the NCE for diabetes. Victoza is the NME for Obesity. Different names, different insurance coverage, different strength.
In 10-Q "Similarly, on August 30, 2017, Amarin filed a lawsuit with the United States International Trade Commission, or the ITC, against manufacturers, importers, and distributors of products containing synthetically produced omega-3 products in ethyl ester or re-esterified triglyceride form that contain more EPA than DHA or any other single component for use in or as dietary supplements. The lawsuit sought an investigation by the ITC regarding potentially unfair methods of competition and unfair acts involving the importation and sale of articles in the United States that injure or threaten injury to a domestic industry. In October 2017, the ITC determined to not institute our requested investigation. We appealed this determination to the U.S. Federal Circuit, but that court upheld ITC’s determination. On July 30, 2019, we filed with the U.S. Supreme Court seeking to appeal the Federal Circuit decision. We have also engaged with FDA on the topic of synthetically produced omega-3 products through the citizen’s petition process and otherwise."
You are right, 2c will not make a difference. This is a volume/growth story. Profits will be here soon enough.
Adam did not post anything new. Another poster reminded us by retweeting Adam that yesterday was the last day that he thought there could potentially be a ADCOM notice. According to Adam's math AMRN is in the clear.
There is a website called open secrets. It list each company that hires lobbyist. It them list the company name that they hired and the lobbyist name. Once you get the hang of the website you can also see the Bills moving through congress and the things they are working on. Hiring lobbyist ( or parts of lobbyist time) is routine for Pharma companies and Amarin.
Amarin Announces Underwriters’ Full Exercise of Option to Purchase Additional American Depositary Shares
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July 29, 2019 17:17 ET | Source: Amarin Corporation plc
BEDMINSTER, N.J., and DUBLIN, Ireland, July 29, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that, in connection with its previously announced underwritten public offering of American Depositary Shares (“ADSs”), the underwriters of the offering have exercised in full their option to purchase up to an aggregate of 3,333,333 additional ADSs. The exercise of this option increases the size of the offering to an aggregate of 25,555,556 ADSs at a price to the public of $18.00 per ADS. The gross proceeds of this offering are expected to be approximately $460.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Amarin. The purchase of the additional ADSs closed on July 29, 2019.
Amarin intends to use the net proceeds from the offering (1) to support the ongoing and expanding commercialization of Vascepa® (icosapent ethyl) assuming the FDA approves Amarin’s supplemental new drug application seeking an expanded indication for Vascepa in the United States based on the positive results of Amarin’s REDUCE-IT™ study, including (i) doubling the size of its existing sales force, (ii) increasing branded and non-branded advertising, and (iii) supporting its expanded commercial operations; (2) to increase commercial supply of Vascepa from third-party drug product suppliers; and (3) for general corporate purposes. Amarin also may use a portion of the net proceeds to acquire strategic assets, although it currently has no agreements or commitments in this regard.
J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC and Cantor Fitzgerald & Co. acted as the joint book-running managers for the offering. H.C. Wainwright & Co., LLC and Roth Capital Partners acted as the co-managers for the offering.
The securities described above were offered by Amarin pursuant to a shelf registration statement on Form S-3ASR (No. 333-216385) previously filed with the Securities and Exchange Commission (the "SEC") on March 1, 2017 and automatically became effective upon filing. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. A final prospectus supplement and accompanying prospectus has been filed with the SEC. Copies of the final prospectus supplement relating to these securities may be obtained for free by visiting EDGAR on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717; or by telephone at (866) 803-9204; or by email at prospectus-eq_fi@jpmchase.com, Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone: (877) 547-6340 or email: Prospectus_Department@jefferies.com or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022; or by email at prospectus@cantor.com.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Amarin
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.
Disclosure Notice
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements related to Amarin's public offering of American Depositary Shares and the FDA’s evaluation of Amarin’s pending supplemental new drug application, are forward-looking statements that involve risks and uncertainties. Words such as "intends," "plans," "expects," "may," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are not promises or guarantees. These forward-looking statements are based upon Amarin's current expectations. Actual events and results and the timing of events and results could differ materially from those anticipated in such forward-looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: risks related to the underwriters’ consummation of their obligation to purchase the securities, whether Amarin will be able to satisfy its obligations to close the offering and the risk that Amarin will not use the proceeds from the offering in the manner contemplated, as well as the risks, uncertainties and other matters detailed in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q and the preliminary prospectus supplement relating to the offering and filed on July 17, 2019. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as required by law.
Amarin contact information:
Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:
Gwen Fisher
Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 325-0735
pr@amarincorp.com
Here is the Veterans Affairs written justification for the Icosapent Ethyl trial that is going on. "The omega-3 fatty acid eicosapentaenoic acid (EPA) improves arterial function and cerebral blood flow, attenuates adverse brain changes related to ?-amyloid protein, and improves cognition in animals - changes that could all potentially protect against AD" Looks like good verbiage to look at.
Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults
Carlsson, Cynthia M.
Wm S. Middleton Memorial Veterans Hosp, Madison, WI, United States
See 18 grants from Cynthia Carlsson
See 158 grants from Wm S. Middleton Memorial Veterans Hosp
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Abstract
Over five million Americans have Alzheimer's disease (AD), and this number is expected to triple by 2050 unless effective preventive strategies are identified. Veterans are at an even higher risk for AD than the general population, possibly due to their increased exposure to factors that accelerate AD pathology, including vascular risk factors, traumatic brain injury, and post-traumatic stress disorder. AD pathology occurs decades before cognitive symptoms occur and is characterized by amyloid plaques, neurofibrillary tangles, and reduced regional cerebral blood flow in areas of the brain related to memory and learning. While cerebral arterial dysfunction occurs early in the development of AD pathology and decades before symptoms begin, the effects of treating such early vascular dysfunction in the brain are poorly understood. The omega-3 fatty acid eicosapentaenoic acid (EPA) improves arterial function and cerebral blood flow, attenuates adverse brain changes related to ?-amyloid protein, and improves cognition in animals - changes that could all potentially protect against AD. However, it is not clear whether EPA beneficially affects these processes or cognitive performance in cognitively-healthy adults at increased risk for AD. In 2012, the Food and Drug Administration approved the first high-dose prescription EPA-only medication to treat hypertriglyceridemia, called icosapent ethyl (available as Vascepa(r) in the United States). This agent is readily available for use and has a good safety profile, making it a favorable agent to consider for AD prevention. The proposed study is a proof-of-concept, randomized, placebo-controlled, double-blind, parallel-group clinical trial assessing the efficacy of 18 months of icosapent ethyl therapy on magnetic resonance imaging (MRI), cerebrospinal fluid (CSF), and cognitive biomarkers for AD in 150 cognitively-healthy Veterans ages 50-70 with increased risk for developing AD due to parental history of the disease and increased prevalence of apolipoprotein E ?4 (APOE4) allele. The overarching goal of this trial is to assess whether icosapent ethyl beneficially affects intermediate physiological measures associated with onset of AD in order to evaluate whether larger, multi-site, longer-duration Alzheimer's prevention trials are warranted to assess more definitive clinical outcomes. Hypothesis: In middle-aged and older cognitively-healthy Veterans with parental history of AD and high APOE4 prevalence, 18 months of treatment with icosapent ethyl will beneficially modify preclinical AD biomarkers, including regional cerebral blood flow, CSF markers of AD pathology, and cognitive performance.
Specific Aim 1 : To investigate the effects of 18 months of icosapent ethyl 4 g daily vs. placebo on arterial spin-labeling MRI regional cerebral blood flow in a pre-defined statistically-identified region of interest affected early in preclinical AD;
Specific Aim 2 : To determine the impact of 18 months of icosapent ethyl vs. placebo on CSF biomarkers of preclinical AD pathology (CSF ?-amyloid- 42, total tau, and phosphorylated tau181);
Specific Aim 3 : To evaluate the effects of 18 months of icosapent ethyl vs. placebo on a composite measure designed to assess preclinical cognitive changes - the Alzheimer's Disease Cooperative Study (ADCS) Preclinical Alzheimer's Cognitive Composite (PACC). If icosapent ethyl beneficially modifies AD biomarkers in at-risk Veterans, the results from the proposed trial would be used to develop multi-site, longer-duration clinical trials using the VA Cooperative Studies Program to assess the efficacy of icosapent ethyl on not only AD biomarkers, but also on more clinically definitive outcomes, such as rate of cognitive decline and conversion to mild cognitive impairment (MCI). If future studies show that icosapent ethyl delays the onset of AD by even an average of 5 years, estimates suggest that this could reduce the prevalence of AD by about 50%.
Public Health Relevance
The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020, including 140,000 cases directly attributable to military service. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of our study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.