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Hunter Biden reportedly sought assistance from the U.S. government for a lucrative energy project in Italy when President Biden was serving as vice president, highlighting allegations that he used his father’s political standing as leverage for his foreign business interests. 

The younger Biden wrote at least one letter to the U.S. ambassador to Italy in 2016 seeking assistance for the Ukrainian gas company Burisma, where he was a board member, according to newly released records and interviews cited by the New York Times.

The response was lukewarm, as officials were somewhat hesitant to help with a request from the son of a sitting vice president on behalf of a foreign company. 

‘This is a Ukrainian company and, purely to protect ourselves, U.S.G. should not be actively advocating with the government of Italy without the company going through the D.O.C. Advocacy Center,’ an official wrote. 

The acronyms refer to the United States government and a Department of Commerce program that supports American companies that seek business with foreign governments.

‘I want to be careful about promising too much,’ wrote a Commerce Department official based in the U.S. Embassy in Rome who responded. 

Hunter Biden asked several people if they could arrange an introduction between Burisma and the president of the Tuscany region of Italy, where Burisma was pursuing a geothermal project, Abbe Lowell, Biden’s lawyer, said. 

He said no meeting had occurred.  

‘No meeting occurred, no project materialized, no request for anything in the U.S. was ever sought and only an introduction in Italy was requested,’ 

In a statement to the Times, Lowell said the outreach by Biden was a ‘proper request.’

President Biden wasn’t aware that his son reached out to the U.S. Embassy in Italy on behalf of Burisma when he was vice president, the White House said. 

Hunter Biden has not been charged with violating the Foreign Agents Registration Act, or FARA, which requires people to disclose when they lobby the U.S. government on behalf of foreign interests.

Fox News Digital has reached out to the State Department and the White House. 

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The State Department announced that it had approved $20 billion in arms sales to Israel as the region continues to spiral towards a wider war in the Middle East.

The advance includes a myriad of weapons such as fighter jets and equipment worth nearly $19 billion, tank cartridges valued at $774 million, explosive mortar cartridges valued at over $60 million and army vehicles worth $583 million, the Pentagon said in a statement.

‘The United States is committed to the security of Israel, and it is vital to U.S. national interests to assist Israel to develop and maintain a strong and ready self-defense capability. This proposed sale is consistent with those objectives,’ the State Department said.

In a statement, Israeli Minister of Defense Yoav Gallant thanked the U.S. for allowing Israel to maintain a ‘qualitative military edge in the region.’

‘Thank you to Secretary of Defense Austin and Secretary of State Blinken for advancing critical force buildup initiatives that assist Israel in developing and maintaining its qualitative military edge in the region,’ he posted on X. ‘This includes incorporating F-15IAs into the IAF fleet of fighter aircraft, and providing critical munition to ensure Israel’s capabilities and security.’

‘As we fight to defend Israel on 7 different fronts, your message of support and commitment to Israel’s security are clear,’ he said.

The impending sale comes as regional tension hurtles towards a breaking point. 

Regional sources told Fox News chief foreign correspondent Trey Yingst on Monday that they are concerned Iran and its proxies could attack Israel within the next 24 hours in retaliation for the killing of Hamas political leader Ismail Haniyeh in Tehran late last month.

On Monday, the Lebanon-based terrorist group Hezbollah launched 30 rockets into northern Israel, although no casualties were reported, according to the Israeli Defense Forces (IDF). 

‘Following sirens that sounded a short while ago in northern Israel, approximately 30 projectiles were identified crossing from Lebanon toward the area of Kabri, a number of which fell in open areas,’ an IDF spokesman said. 

The $20 billion in arms sales are not expected to be delivered to Israel soon, with the sales expected to secure the nation’s resources long-term.

Fox News Digital’s Greg Norman and The Associated Press contributed to this report.

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President Biden repeated a claim he had been fact-checked for in the past, telling an audience on Tuesday that he traveled 17,000 miles with Chinese President Xi Jinping.

‘I spent a lot of time with Xi Jinping,’ he said during his remarks at an event touting the Biden ‘Cancer Moonshot’ initiative in New Orleans, Louisiana.

‘I spent over 80 hours with him alone. Over 17,000 miles in China, anywhere in Tibet, near Tibet.’ 

He described telling the Chinese president that ‘possibility’ is the one word that can define America, tying his analogy to the Cancer Moonshot initiative. 

Biden’s claim that he has traveled more than 17,000 miles with Xi has previously been fact-checked and considered primarily inaccurate, however. 

He has made the claim many times over several years and was fact-checked by the Washington Post in 2021. ‘Try as we could, however, we still could not get the travel to add up to 17,000 miles,’ wrote the publication. 

Biden was given three pinocchios for his claim. 

According to the Post, this number of pinocchios means there is ‘significant factual error and/or obvious contradictions.’ It is comparable to a rating of ‘mostly false.’

The White House did not immediately respond to inquiries from Fox News Digital. 

Biden announced $150 million in ARPA-H awards to develop technologies that will allow surgeons to provide more successful tumor-removal surgeries for people facing cancer at the event in New Orleans.

After having dropped out of the 2024 presidential race last month and endorsing Vice President Kamala Harris to succeed him, Biden is now reportedly focusing on the causes that are most personal for him in his remaining months as president. 

Cancer research is of ‘immense importance’ to the president, an aide told CNN.

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Republican Erik Olsen defeated his primary opponent Tuesday night in Wisconsin’s 2nd Congressional District, setting up a battle to unseat Democrat Rep. Mark Pocan in the deep-blue district. 

The 2nd District spans the capital city of Madison – the most politically liberal city in the state – and Dane County. 

Madison attorney Erik Olsen defeated Charity Barry, a ground crew supervisor, in a primary that was a rematch of the pair’s race in 2022. Olsen beat Barry in that first race by just 63 votes, according to a report in Wisconsin Public Radio.

Olsen will challenge Rep. Pocan for the seat he’s held since 2013. 

‘It’s been a very quiet contest in a district that is not likely to elect a Republican anytime soon,’ University of Wisconsin-Madison political science professor Barry Burden told Wisconsin Public Radio. ‘But this is at least an opportunity for the party to pick a favorite and try to make a stab at winning a difficult seat.’

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Rep. Thomas Massie is suggesting that Republicans could dismantle the Department of Education (DOE) if the GOP wins control of both Congress and the White House in November.

‘Would [former President Trump] follow through with it? Honestly, I think it depends on who controls Congress and who his Cabinet secretary is,’ the Kentucky Republican told Fox News Digital on Tuesday.

The Kentucky Republican made the comments the day after Trump’s interview on X with owner Elon Musk in which Trump suggested doing the same.

‘What I’m going to do, one of the first acts – and this is where I need an Elon Musk; I need somebody that has a lot of strength and courage and smarts – I want to close up the Department of Education, move education back to the states,’ Trump said Monday night.

Massie introduced a bill late last year that would do just that, and it currently has more than 30 House GOP co-sponsors, including vocal Trump allies like Reps. Marjorie Taylor Greene, R-Ga., and Byron Donalds, R-Fla.

While he has not had conversations with Trump or his campaign about the bill, Massie said it’s an issue he’s discussed with the Trump-aligned Republican lawmakers ‘all the time.’

It signals that the effort, long pushed by conservatives, could potentially materialize if Trump and Republicans take over the levers of power in Washington in November.

The DOE was established under former President Carter in 1979 when he split it from the Health and Human Services Department. It’s charged with regulating federal student aid funds and ensuring equal access to education, among other responsibilities.

It faced conservative backlash almost instantly, with former President Reagan threatening to dissolve it, though he was ultimately unsuccessful. 

‘Reagan promised that he would try to eliminate it, and he never did. And then [people] became comfortable with [the] Department of Education, and it started seeming like a radical notion just to do what Ronald Reagan said he would do, so I felt the need to reintroduce this bill,’ Massie said.

The Kentucky Republican, who has been at odds with Trump in the past, said he was ‘pleasantly surprised’ to hear him discuss it on Monday.

He argued that the funding that goes toward managing the DOE and its 14,000 Washington, D.C., employees ‘could be distributed to the school systems instead of burning … on extra red tape.’

Massie also said that other core facets of academic policy like student lunches and the Head Start program are run by the Department of Agriculture and HHS, respectively.

More than 160 Republicans voted for an amendment by Massie to dismantle the DOE in March 2023, though it ultimately failed.

But despite its foundations in the Reagan era, the push to dismantle the DOE has been used as a political cudgel by Democrats after its inclusion in Project 2025, a Heritage Foundation-backed set of policies and recommendations for a new Republican administration.

Trump and his allies have distanced themselves from Project 2025, which Democrats have cast as a far-right and repressive vision for the country.

Massie similarly said he had no knowledge of Project 2025’s details, pointing out that he’s pushed to end the DOE before the initiative was formed.

‘I would just say, regardless of any other initiatives, this stands on its own. Organizations like the Heritage Foundation [and FreedomWorks] have been for getting rid of the Department of Education … since they were created, and Reagan was for it,’ Massie said. ‘So, I don’t think it’s a radical notion. I think what’s radical is having a federal school board. And I think education is better without it.’

Massie indicated he would support former Education Secretary Betsy DeVos – who has advocated for phasing out the department she ran – to head it again.

The Trump campaign did not comment directly on Massie’s bill but told Fox News Digital when asked, ‘As President Trump has repeatedly stated on the campaign trail, he is committed to cutting the Department of Education and returning important decisions about education back to parents, teachers and educators at the state level. The DOE has been failing America’s students for too long, and it’s time for serious change.’

When asked for comment, the DOE referred Fox News Digital to Vice President Harris’ campaign, which did not immediately return a request for comment.

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With Vice President Kamala Harris riding a wave heading into next week’s Democratic National Convention, former President Trump and his campaign appear to be stepping up their efforts to blunt her momentum.

Trump’s campaign tells Fox News it plans to counter-program during the Democrats’ national nominating convention, which kicks off next Monday in Chicago.

‘We’re going to roll out some stuff,’ a Trump campaign senior adviser told Fox News.

The adviser, who asked to remain anonymous to speak more freely, said the campaign will put ‘a whole cadre of people’ – including Trump and top surrogates – into the field next week.

‘We’re certainly going to have key people in the battlegrounds and available to the media to counterprogram,’ the adviser said. 

And one of those key people will be Republican National Committee chair Michael Whatley, Fox News has learned.

In years past, it was traditional for a presidential candidate to lay low while the other party held its national nominating convention. 

But last month, as the Republicans held their convention in Milwaukee, President Biden briefly campaigned in the key swing state of Nevada before cutting his trip short after catching COVID.

Days later, Biden’s blockbuster announcement that he was ending his re-election campaign following his disastrous late June debate performance against Trump upended the 2024 election.

At his more than hour-long news conference last week, Trump argued that he wasn’t currently criss-crossing the campaign trail because he is leading in the race — even as the latest polls indicate Harris has closed the gap in national and key battleground state surveys. 

Trump defended his pace on the campaign trail, saying he’s ‘competing a lot’ and added that he would further pick up the pace ‘after their convention.’

Sources in Trump’s political orbit tell Fox News that top advisers to the former president are quietly aiming to persuade Trump to tamp down the insults to Harris and the questioning of the vice president’s racial identity and instead focus on branding her an ultra-liberal and spotlighting her stance on the border, crime and inflation

Trump allies are also publicly pitching Trump to refocus his attention.

‘You’ve got to make this race not on personalities,’ former House Speaker Kevin McCarthy said Monday in an interview on Fox News’ ‘America’s Newsroom.’ ‘Stop questioning the size of her crowds and start questioning her position.’

McCarthy emphasized that Trump has ‘a short time frame to do it, so don’t sit back. Get out there and start making the case.’

Trump is expected to spotlight an economic argument against Harris on Wednesday at a campaign event at the Harrah’s Cherokee Center’s Thomas Wolfe Auditorium, in Asheville, North Carolina.

It’s the former president’s second stop in the crucial southeastern battleground state in the three and a half weeks since Harris replaced Biden at the top of the Democrats’ 2024 ticket.

The Trump campaign earlier this week announced that the former president will hold a rally in another crucial swing state – Pennsylvania – on Saturday.

And Trump’s running mate, Sen. JD Vance of Ohio, holds campaign events Wednesday in Michigan, Thursday in Pennsylvania, and Friday in Wisconsin.

The former president on Monday returned to X [formerly known as Twitter], where he posted a series of campaign videos leading up to his interview hours later with Elon Musk. The multi-billionaire investor who is considered one of the richest people in the world, owns the social media platform and earlier this summer officially endorsed the former president.

Trump, who was banned from Twitter for a couple of years, made a brief return last year to post his mugshot and a link to collect fundraising donations, before going dark again until Monday.

But Trump’s campaign says the return to X isn’t a one-off this time around.

A Trump campaign senior adviser emphasized that moving forward, we’re ‘going to continue to see a lot of alternative platform work.’

‘You’ll see him on X talking to millions of people. You’ll see him on all kinds of conversational podcasts and streams coming up the rest of the campaign. And he’ll still be doing – as he always does – press availabilities, and he will obviously keep doing rallies and special large audience events,’ said the adviser, who also asked for anonymity to speak more freely.

‘Whether it’s on X or any of these other things, the president is unafraid of having unscripted conversations about the issues that matter, in stark contrast to Kamala Harris,’ the adviser added.

While technical difficulties which delayed the interview with Musk for over 40 minutes grabbed headlines, Trump also gained over 900,000 new followers on X as of Monday night.

Dan Eberhart, an oil drilling chief executive officer and a prominent Republican donor and bundler who raised big bucks for Trump’s 2020 re-election campaign and who is supporting Trump again after backing Florida Gov. Ron DeSantis in the GOP presidential primaries, told Fox News that ‘you’ve always got to be assessing the state of the race, and I would like to see more offense from the Trump campaign. Trump, the man, is the campaign’s best asset. Put him out there.’

‘Immediately after the Democrat convention closes, I would like to see the gloves come off in a full-throated campaign for Trump,’ Eberhart emphasized.

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Since its violent revolutionary founding, the Islamic Republic of Iran has spread chaos around the world, attempted to assassinate Americans on our own soil and vowed to destroy Israel, our closest ally in the Middle East. America remains far stronger than Iran, yet a Kamala Harris presidency would empower this terrorist regime to do far worse.  

Every American should be deeply concerned that Vice President Harris’s weakness would only continue Joe Biden’s policy of emboldening and enriching Iran. 

For decades, Iran — directly and through proxies — has committed and underwritten terrorism with the explicit goal of killing Americans and expelling us from the Middle East so that the ayatollahs can dominate this vital region.  

The ayatollahs came to power in 1979, holding more than 50 Americans hostage for more than a year during the Carter administration. In 1983, Iran and its terror proxies murdered hundreds of American Marines stationed in Beirut. And during the Bush administration, Iran’s proxies kidnapped Americans in Lebanon and murdered U.S. airmen in Saudi Arabia. 

The terror campaign continued against our troops in Iraq, which I saw firsthand as Iranian-backed terrorists killed hundreds of Americans. Iran, by the best estimates, was responsible for more than 600 American deaths in Iraq. 

In contrast to the Obama administration’s weakness, Iran largely pulled in its horns during the Trump presidency for a simple reason — the ayatollahs once again feared America.  

Under President Donald Trump, Iran’s economy went into free fall, limiting its ability to fund its shock troops around the world. Afraid of American retaliation, Iran and its proxies didn’t carry out major terrorist attacks. And the Iranian nuclear program was mostly contained after the U.S. removed itself from Barack Obama and Joe Biden’s unenforceable Iran deal. 

Sadly — and dangerously — none of that is true today.    

Thanks to the Biden-Harris administration’s refusal to enforce sanctions, Iran’s economy has rebounded and even expanded. Iran’s oil exports have more than quadrupled, giving it the cash to fund attacks on our troops in the Middle East and our allies, as well as assassination plots against Trump and others. The Biden administration even used U.S. taxpayer dollars to pay ransom to Tehran for wrongly detained prisoners.    

Today, Iran is not deterred, as our military commander in the region confirmed when I questioned him in a congressional hearing in March.    

The ayatollahs are killing American troops, and they’re responsible for supporting Hamas’s October 7 attack on Israel. They’re funding their proxies across the Middle East; Iranian-backed militias in Iraq, Syria, and Jordan have attacked U.S. forces more than 175 times since October 7. In response, we have responded an anemic 11 times as of July 30.   

But as bad as Biden has been, Kamala Harris’s policies are — and would be — far worse.   

As vice president, she has surrounded herself with pro-Iran advisors: her National Security Advisor Phil Gordon is linked to a senior Pentagon official reportedly involved in an Iranian influence operation. At the same time, she has tried to bully Israel’s Prime Minister Benjamin Netanyahu into accepting Hamas’s ceasefire demands.  

And if she becomes president, Harris would kill American energy production, benefiting Iran with higher oil prices.  

Harris’s weak, conciliatory views towards the ayatollahs, combined with her catering to the pro-Hamas wing of the Democratic Party, would gravely endanger our national security and undermine the confidence and security of our allies. 

For decades, Iran — directly and through proxies — has committed and underwritten terrorism with the explicit goal of killing Americans and expelling us from the Middle East so that the ayatollahs can dominate this vital region.  

Instead, what America needs is peace through strength — something Harris will not and cannot deliver. What we need is a return of President Trump and his successful policies to the White House.,

He killed Qasem Soleimani and deterred further attacks by Iran. That’s the strong, decisive leadership America needs: instead of appeasing the ayatollahs, Trump stood up to them. It worked once, and he can do it again.

 

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American Rare Earths Limited, (ASX: ARR | OTCQX: ARRNF | ADR: AMRRY) (“ARR” or the “Company”) is pleased to advise that following an extensive strategic review focusing on the development of the Halleck Creek resource, the Board has undertaken operational and structural changes to best position the Halleck Creek Project as a strategic resource to US markets. These changes will make Halleck Creek more accessible to major US investors to help facilitate its development while enhancing value to our existing shareholders.

Highlights

A new focus on the development of the Halleck Creek Project to enhance shareholder value.100% owned subsidiary, Wyoming Rare USA Inc., dedicated to developing the Halleck Creek Project.Subsidiary allows for US based investment and partnerships.A Wyoming project with Wyoming leadership to continue with growth trajectory.

As part of these changes, the Project will be developed under 100% ARR owned, Wyoming Rare (USA) Inc. (“WRI”) with its own dedicated capital structure and funding sources, positioning it as an attractive prospect for US based investment and partnerships.

WRI will focus on development of the Cowboy State Mine on a portion of the Halleck Creek Wyoming State Tenements. With the recent energy fund grant from the State of Wyoming and pathway to permitting, WRI is positioned to accelerate development of one of the largest rare earth deposits in North America. The Project has significant upside potential with less than 75% of mineralised zones yet to be drilled and deposit remaining open at depth. As released to the market on 18 March 2024, the Scoping Study identified the fundamental commercial viability of this approach, with an NPV of US$673.9m, an IRR of 22.5% and payback period of 2.9 years, with total initial capex of US$456.1m1.

ARR Chairman, Richard Hudson commented: “This new focus represents a pivotal moment for ARR. By creating a dedicated subsidiary for the Halleck Creek Project, we are positioning the Company to unlock significant value and accelerate the development of a critical resource for the US. These changes will not only streamline our operations but enable us to better increase shareholder value long term.”

Enhanced Operational Focus for Wyoming Rare (USA) Inc.

To advance the development of the Halleck Creek Project, WRI will be led by the following highly experienced leadership team:

Sten Gustafson, Vice Chair of the American Rare Earths Board, has been appointed Chairman of WRI. Sten is currently the Chief Executive Officer and a Director of Pyrophyte Acquisition Corp. (NYSE: PHYT), a SPAC focused on companies that provide products, services, equipment and technologies that support a variety of energy transition solutions. Sten is a highly experienced energy service industry executive, investment banker and corporate securities attorney. With over 25 years of experience in the global energy sector, Sten has advised on more than 100 corporate transactions worldwide for over US$100b of transaction value.

Joe Evers, ARR’s current General Counsel will be appointed President for WRI. He was instrumental in securing a US$7.1 million grant from the State of Wyoming with support from partners Wyoming Energy Authority and the University of Wyoming Energy Resources Council. Joe has served in various leadership roles throughout the energy and mining industry, held positions of increasing responsibility in a publicly traded oil and gas company, served as corporate counsel at an international mining company and worked with clients engaged in natural resource development in the Rocky Mountain region. Joe is a graduate of the University of Wyoming and a Sheridan, Wyoming native.

John Mansanti will be appointed as a Senior Advisor to WRI supporting the development of the Cowboy State mine. John will be instrumental to advance the project and will be resigning from the ARR Board to support WRI. John has more than 45 years’ experience leading successful teams in project development, engineering, project financing, capital execution, and operations in North America. John led several teams in the successful procurement of project permits and project execution.

ARR will continue its exploration activities in both Australia and America particularly focusing on critical minerals.

Donald Swartz has decided to explore new opportunities, while continuing to provide advisory services during the transition to new leadership over the next 90 days. Chris Gibbs will be appointed as Chief Executive Officer of the Company. With over 25 years in the resource industry, Chris brings a wealth of experience in executive, operational, and strategic leadership roles across various major global stock exchanges. Currently on the ARR Board as a Non- Executive Director, he was previously the CEO and Managing Director for the Company. Chris is also on the Board of Directors for the Critical Minerals Institute.

ARR Chairman, Richard Hudson, commented“The Halleck Creek Project is key to the State of Wyoming, and we are committed to delivering value for our shareholders through dedicated development and strategic partnerships. The changes we have determined will allow the full value of Halleck Creek to be realised as a strategic project for North America, while ensuring ARR continues its highly successful exploration activities in pursuit of our vision to be a leading player in the critical minerals sector.”

Click here for the full ASX Release

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Labyrinth Resources Limited (‘the Company’ or ‘Labyrinth’) advises that it is seeking shareholder approval at the upcoming Extraordinary General Meeting of Shareholders (‘EGM’) to be held on Friday, 13 September 2024, to consolidate the issued capital of the Company.

Labyrinth is proposing to consolidate:

a) every 10 Shares into 1 Share;

b) every 10 Options into 1 Option; and

c) every 10 Performance Rights into 1 Performance Right, (‘Consolidation’).

As the Consolidation applies equally to all security holders, it will have no material effect on the percentage shareholding interest of each individual shareholder.

The indicative timetable for the Consolidation is as follows:

The above dates are indicative only and subject to change.

For further details in respect of the proposed Consolidation, refer to the Company’s Notice of EGM lodged with the Company’s ASX platform on 14 August 2024.

Click here for the full ASX Release

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TrivarX Limited (‘the Company’) (ASX: TRI) is pleased to announce positive top-line results from the Company’s recently completed Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study utilising its proprietary AI-backed algorithm, MEB-001. MEB-001 uses EEG and ECG signals recorded during sleep to identify current Major Depressive Episode (cMDE).

Highlights:

Analysis of 400 patients in Phase 2 SAMDE study for current Major Depressive Episode (cMDE) study utilising MEB-001MEB-001 is TrivarX’s proprietary AI-driven algorithm which can assist with the effective screening of a cMDEMEB-001 performance results from Phase 2 SAMDE study reported high performance, marking a significant achievement in the Company:Sensitivity: 87% (95% CI 73-95%)Specificity: 72% (95% CI 66-77%)Positive Predictive Value: 35% (95% CI 27-45%)Negative Predictive Value: 97% (95% CI 93-99%)Results provide strong validation of MEB-001’s ability to assist in the screening and diagnosis of a cMDE – a condition which is commonly misdiagnosedThere is currently no screening undertaken for cMDE in sleep centres in the US or globally, representing a major commercial opportunity for TrivarXResults advance TRI’s aim to become the first depression screening tool used in clinical practice in sleep centres

There is a well-established connection between mental health conditions, such as depression, and sleep disturbances. People with insomnia may have a tenfold higher risk of developing cMDE and among people with depression, 75% of sufferers have trouble falling or staying asleepi. Furthermore, misdiagnosis of major depressive disorder is estimated at upwards of 65% in the USii. Despite this, depression screening is not routinely included in sleep studies, even though up to 21% of people undergoing a sleep study have depressioniii.

Positive results from SAMDE study highlight MEB-001’s significant potential:

The objective of the study (ClinicalTrials.gov ID NCT05708222) was to use MEB-001 to detect the likelihood of a cMDE using Clinician Reporting Outcomes (CRO) assessment in individuals referred to a sleep clinic. A total of 400 patients were recruited across 15 sleep centres in the US. Out of these, 73 patients were excluded due to incomplete data or a split night/titration sleep study. MEB-001 also automatically identified 32 patients with significant anomalies in their sleep data. Notably, the MEB-001 algorithm was locked prior to the analysis ensuring no data from Phase 2 was used in its training.

Analysis of the results showed that MEB-001 reported promising performance across key parameters including sensitivity of 87% (95% CI 73-96%), specificity of 72% (95% CI 66-77%), positive predictive value (PPV) of 35% (95% CI 27-45%) and negative predictive value (NPV) of 97% (95% CI 93-99%) (refer table below).

These results provide considerable validation of MEB-001 and its ability in the screening and diagnosis of a current Major Depressive Episode (cMDE) in test subjects.

Management commentary:

Non-executive Chairman, David Trimboli said: “We are very excited to share the results from our Phase2 study, which highlight the effectiveness of MEB-001 in screening for cMDE. This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which was increased from 71% in Phase 1, to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE. Our very high NPV validates MEB-001’s potential as a screening test, with the likelihood of having depression when testing negative to be less than 3%.

“There is currently no screening undertaken for cMDE in sleep centres in the US or globally. Our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres and marks a significant achievement in the Company’s history.”

Click here for the full ASX Release

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