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Lumos passes milestone in CLIA waiver

Lumos passes milestone in CLIA waiver

Herald Sun03-06-2025

Don't miss out on the headlines from Stockhead. Followed categories will be added to My News.
Lumos enrols 61 of required 120 bacterial positive patients in US CLIA waiver clinical study for FebriDx
Study to be completed by Q4 2025 with US FDA CLIA waiver application to be submitted in October 2025
Successful CLIA waiver would unlock access to a US total addressable market exceeding US$1 billion
Special Report: Lumos Diagnostics has passed a major milestone in a US CLIA waiver study for its rapid point-of-care diagnostic FebriDx designed to differentiate between bacterial and non-bacterial acute respiratory infections.
Developer of rapid, point-of-care testing Lumos Diagnostics (ASX:LDX) has achieved 61 bacterial positive patients representing 50% of the target of 120 bacterial positive patient results required for its ongoing CLIA waiver study.
Lumos said there had been 439 patients enrolled in the study and testing of the 500th patient would trigger a US$298,457 milestone payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA).
The bacterial prevalence rate in the study so far is at an average of 14% (61/439).
However, since Lumos implemented its enrichment strategy in late March the company said the bacterial prevalence rate in the trial had been around 35%.
This study is a critical step towards securing a CLIA waiver from the US Food and Drug Administration (FDA).
It would enable FebriDx to be used in a broader range of healthcare settings, including physician offices, urgent care clinics or other outpatient clinics that do not operate under high-complexity laboratory certification.
At the current accrual rate, Lumos said the study was anticipated to conclude in Q4 2025.
Subject to successful data outcomes, Lumos expects to submit its CLIA waiver application to the FDA in Q4 2025.
Addressing overuse of antibiotics
FebriDx is a unique, rapid test that helps clinicians differentiate between bacterial and non-bacterial acute respiratory infections through a simple fingerstick blood sample, delivering results quickly at the point-of-care.
The test enables clinicians to make more informed treatment decisions at the initial point of care, supporting appropriate antibiotic stewardship and helping to combat the global challenge of antimicrobial resistance.
By aiding clinicians in faster, better decisions at the point-of-care, Lumos said FebriDx had the potential to improve patient outcomes, reduce unnecessary antibiotic prescriptions, and lower overall healthcare costs.
The World Health Organization has warned that the global surge in antibiotic resistance is undermining the effectiveness of commonly used antibiotics to treat widespread bacterial infections.
Lumos said in the US antibiotic-resistant infections caused ~2.8 million illnesses and 35,000 deaths each year.
'Encouraged by the progress'
Managing director Doug Ward said reaching the halfway mark in bacterial positive patient recruitment for its CLIA waiver clinical study was an important achievement for Lumos.
'We are encouraged by the progress of the study with the support of BARDA and remain focused on delivering a successful outcome that expands the availability of FebriDx to clinicians and patients across the US,' he said.
"A successful CLIA waiver would unlock access to a US total addressable market exceeding US$1 billion and significantly expand the commercial potential for FebriDx in point-of-care settings by up to 15 times our current available market opportunity."
He said the company continues to work closely with its clinical partners to complete enrolment and data collection in a timely manner.
Lumos recently announced it had Medicare reimbursement from six of seven Medicare administrative contractors, representing more than 85% of total US Medicare payment coverage.
This article was developed in collaboration with, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Originally published as Lumos passes milestone in CLIA waiver study for point-of-care respiratory test

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Price wars, cheap airfares and stiff competition for Qantas: What can Aussies expect from the new Virgin Australia?
Price wars, cheap airfares and stiff competition for Qantas: What can Aussies expect from the new Virgin Australia?

Sky News AU

time3 hours ago

  • Sky News AU

Price wars, cheap airfares and stiff competition for Qantas: What can Aussies expect from the new Virgin Australia?

Australia's second largest airline is heading back on the market for the first time since it fell into administration in 2020. Virgin Australia last week finally unveiled initial public offering plans after years of rumours and reports. The carrier confirmed it was offering 30.2 per cent of the company, or $685 million for $2.90 per share, up for grabs from June 24. Australian travellers, the local travel sector and investors are now fixated on exactly what can be expected from the new iteration of Virgin Australia. Virgin's international expansion Virgin Australia returns to the ASX with the backing of one of the world's best regarded carriers as it ventures onto lucrative international routes. Qatar Airways purchased a 25 per cent stake in Virgin and earlier this month began wet-leasing aircraft to the Australian airline, meaning Virgin could use Qatar's planes and staff on its flights. Flight Centre's CEO Graham Turner said Qatar Airways backing Virgin had 'solidified' the airline as it looked to compete with Qantas and the National Carrier's partner Emirates on routes to Europe. 'The airline industry is one where you do need deep pockets and I think that Qatar really offers some serious security there,' Mr Turner told Qatar Airways' additional capacity to Australia via Virgin comes almost two years after Transport Minister Catherine King controversially blocked extra capacity for the carrier. The Albanese government's ties with Qantas, which opposed the flights, came under intense scrutiny as the decision to block the extra capacity came at a time when sky high airfares plagued Aussies travellers. Labor, alongside the Foreign Investment Review Board, approved Qatar's stake in Virgin earlier in the year, boosting hopes for cheaper airfares and more vibrant aviation competition in Australia. The expertise and massive size of Qatar's fleet, which is often ranked as one of the world's top airlines, is considered essential for Virgin's European expansion. 'Having a partner like Qatar that's obviously heavily committed to the Australian international market, particularly to Europe and the UK, is going to be a really positive thing for Virgin here,' Mr Turner said. Virgin is also expected to benefit from a massive investment by Qatar for 210 widebody Boeing aircraft. The editor in chief of aviation website 42 Thousand Feet, Geoffrey Thomas, said the additional aircraft would enable Virgin to relaunch trans-Pacific and Asian routes alongside European flights. 'With Qatar Airways and their buying power … I see them as being a real rock of Gibraltar, if you like, for Virgin,' Mr Thomas told 'In the recent order for about 130 B787s, I see a number of those, possibly 20, making their way to Virgin as part of a bulk buying. 'That will help Virgin relaunch to Asia, relaunch the United States and become a true international airline in its own right.' However, not all are convinced Qatar's involvement with Virgin will send it skyrocketing. Morningstar analyst Angus Hewitt, who has argued Virgin's IPO is overvalued, said the collaboration with Qatar 'does not mean much at all'. He noted Virgin will get some commission and a fixed fee from Qatar, but this would be offset by the cost of selling and delivering the flights. 'The actual earnings impact of the Qatar long haul agreement is going to be negligible,' Mr Hewitt said on Sky News' Business Now. The major value of the agreement, Mr Hewitt argued, came from the boost to Virgin's frequent flyer program Velocity. 'It makes Velocity a more formidable competitor to Qantas Frequent Flyer,' he said. Cheaper airfares? Aussie travellers have been desperate for cheaper domestic and international flights since the pandemic. 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Travel industry figures are hoping Virgin going public could spark a positive change as it looks to deliver long-term profitability. Mr Long said the team at ATIA wanted the carrier to shift from a private equity mindset towards an attitude where it has to generate a solid return to bolster shareholder value. 'We're hopeful that as it becomes listed there should be some improvements in fleet and some improvements on some of the ground product and how they work with corporate Australia,' he said. The Flight Centre boss also stressed the carrier will need to deliver a 'very competitive' product compared to Qantas to ensure its share price can thrive. 'I think most executive teams and Virgin's, I'm sure knowing them, realise that service standards have to come up to a certain level and so that's important for the share price as much as the profitability,' Mr Turner said. But Virgin may not only have Qantas to worry about as it seeks to drive its stock price. 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The next ASX mining takeover targets
The next ASX mining takeover targets

The Australian

time3 hours ago

  • The Australian

The next ASX mining takeover targets

M&A has emerged as one of the key mining investment themes of 2025 Billions are being splurged by cashed up majors on undervalued small and mid caps We ask five experts which ASX companies could become takeover targets next No theme has shouted louder in the junior and mid-tier mining space this year than M&A. With majors cashed to the gills and looking to both grow and upgrade their portfolios, and the share prices of junior miners trading at big discounts to the values of their assets, there's no time like the present to get a deal done. The latest non-orchestral manoeuvres in the dark (deals tend to be negotiated after hours under the cover of night by shadowy advisors and lawyers) have included the $1.6bn takeover of MAC Copper (ASX:MAC) proposed by South Africa's Harmony Gold, Dundee Precious Metals' US$1.25bn splurge on Vares silver mine owner Adriatic Metals (ASX:ADT) and the $185m deal for Arizona copper stock New World Resources (ASX:NWC) from London-listed Central Asia Metals. It's shares are now in a halt above the 5c offer price with the company paused for a proposed increase in the scheme consideration (ie more dosh for investors) as PE Kinterra Capital, owner of the shuttered Pumpkin Hollow copper mine in nearby Nevada, emerged as a near 12% shareholder of NWC. Intrigue, subterfuge and, most importantly, gains are all on the menu for ASX investors as larger international players and cashed up gold and copper producers look to pick up new projects. The question is not whether there will be more takeover activity. The question is, in the immortal words of Bill Goldberg, WHO'S NEXT?! We won't deign to suggest we have the keys to the castle here. But we have tapped our extensive list of experts, with analysts and fund managers giving us their tips for who may be the next corporate prey. David Franklyn – Argonaut Funds Management Pilbara Minerals (ASX:PLS) A large scale efficient spodumene producer with plenty of cash. If Rio Tinto (ASX:RIO) are committed to becoming a major player in the lithium market then PLS is the logical target. FireFly Metals (ASX:FFM) A standout Canadian copper development opportunity with a growing resource base and good grades. NexGen Energy (ASX:NXG) Nuclear power is gaining increasing momentum globally as a carbon free producer of base load power. If you want to be a major player in the Industry then NXG is the logical acquisition. The Argonaut Natural Resources Fund owns FireFly Metals and NexGen Energy. Andy Clayton – Precision Funds Management NexGen Energy (ASX:NXG) This is a genuine tier-1 asset (high grade, low cost, long life) in a tier-1 jurisdiction/country (Canada). The Rook I feasibility study showed a project capable of producing up to 30Mlb per year at a cash operating cost of US$10/lb. The economics are driven by its ultra high grade, with a reserve of 4.5Mt at 2.37% U3O8 for 239Mlb of U3O8. At a uranium price of US$95/lb, the annual after-tax free cash flow from the project in years 1-5 is US$1.47bn per annum. An NPV8 is estimated at US$4.7bn with an IRR of 45% and capital payback of approximately one year. These are outstanding economics. Once permitting is completed – expected in the next 12-18 months – we believe there is a good chance for corporate activity. Toubani Resources (ASX:TRE) Toubani has an excellent oxide gold deposit in Mali which has potential to produce +150,000ozpa at a low AISC of US$1175/oz for +10yrs. The capital is a modest US$216m and at a US$3000oz gold price a post-tax NPV8 is estimated at US$951m (A$1.46bn) and an IRR of 79%. This compares to TRE's current market capitalisation of a meagre $70m. A recent strategic funding deal to raise $29m which includes a $15.2m placement to an A2MP Investments DMCC, an African focussed investment vehicle owned by Eagle Eye Asset Management sees TRE well funded for the medium term. A2MP and TRE also executed a debt commitment letter for a minimum of US$160m. TRE trades at a fraction of its peer group due to the Malian discount currently being applied (resulting from changes to Mali's mining tax system and recent disputes with western gold miners operating in the country). We believe that as political stability and sentiment returns then TRE is a potential takeover candidate. Encounter Resources (ASX:ENR) Encounter has the largest land holding in the West Arunta region, which over the past three years has seen significant exploration success from its neighbour WA1 Resources (ASX:WA1), which outlined a large, high grade niobium deposit. Successful drilling by ENR in the last field season culminated in a maiden resource of 19.2Mt at 1.74% Nb2O5 from three separate deposits. This resource is expected to grow as further extensional drilling is done in the current field season. WA1 Resources has a market capitalisation of ~$900m – almost 8x that of ENR at $120m – and whilst it's further ahead in terms of development, we ultimately believe there will only be one key player in this area. Whether that is WA1 Resources or another corporate only time will tell, but logic would suggest there is likely to be only one ferroniobium plant build in this remote area. Guy Le Page – RM Capital Meteoric Resources (ASX:MEI) and/or Viridis Mining and Minerals (ASX:VMM) There is increasing demand for strategic rare earth projects to supply NdPr and Dy/Tb outside of China, driven by national interests, particularly in Western countries seeking supply chain security. Recent reports indicate that Lynas (ASX:LYC) is showing growing interest in Brazil for potential rare earth assets, likely aiming to secure supply and diversify geographically. Both Meteoric and Viridis possess ionic clay rare earth projects in Brazil with substantial resources and well-developed flowsheets. Although current financial metrics for these projects are not favourable at prevailing NdPr prices, the global push for secure supply could elevate their strategic value. Their proximity to the US market may also attract interest for potential takeovers, especially as Lynas advances its US operations with backing and funding from American entities. Lynas has been actively expanding its global supply chain, exemplified by its recent partnership with Menteri Besar in Malaysia. This initiative aims to leverage local processing infrastructure and diversify supply sources, further supporting Lynas' interest in ionic clay REE projects. Such moves suggest Lynas may consider acquiring strategically located assets like Meteoric and Viridis to strengthen its position in the global rare earth industry. Tesoro Gold (ASX:TSO) Tesoro owns 100% of the 1.5 Moz El Zorro Gold Project (Ternera deposit), covering 570km2 of highly prospective geology in Chile's Atacama region, approximately 800km north of Santiago. The project benefits from its strategic location near roads, power lines and an airport, and is situated 190km southwest of Gold Fields' (NYSE: GFI) high-grade open-pit gold and silver mine, Salares Norte. El Zorro is Chile's first discovered intrusive-related gold system, with a proven record of a low discovery cost of US$14/oz to date. A scoping study completed in 2023 estimates a 1.3Moz mineral resource within a US$1800/oz pit shell. The study projects an NPV of US$210 million, based on a 2.4Mtpa throughput over an initial 8-year mine life, with an upfront capital expenditure of US$132m. This scoping study represents a preliminary 'starter' pit, and there is considerable upside potential, as the Ternera deposit remains open in all directions and district-scale exploration targets present additional opportunities for resource growth. Gold Fields owns 17.1% of Tesoro and has been providing ongoing technical support for Tesoro's regional exploration efforts. Astral Resources (ASX:AAR) A noteworthy takeover target in the gold space considering their open pit resource of 1.76Moz located 70km of Kalgoorlie. PFS is due late July. Paul Howard – Canaccord Genuity Given 25% of my coverage list was acquired last financial year and two of my covered stocks in ADT and NWC are currently under the microscope, this is a question I'm all too familiar with! (Ed's note: For context, Howard normally has 16-20 stocks under coverage) The mining sector typically expands and contracts over time in terms of number of participants. We had record IPOs post-Covid but now we're in a period of consolidation; the sector is getting smaller as the number of M&A deals increase. Although counter cyclical M&A deals make most sense, I see most upcoming M&A happening in the precious metals space, signalling that we are still far from the top. On the counter cyclical view, I wouldn't write off something happening in the nickel space with the likes of Centaurus Metals (ASX:CTM) (large nickel sulphide project in Brazil, Jaguar) and see opportunities for companies with copper offerings given the notion of decarbonisation and energy transition (Firefly, Cygnus Metals (ASX:CY5) or even Caravel Minerals (ASX:CVV)). But it's in precious metals where I see the most likely deals. Bellevue Gold (ASX:BGL) could go to an established producer in the near term; Antipa Minerals (ASX:AZY) could bolt on to Greatland Gold, continuing its Paterson Province consolidation moves; and the very large Rogozna project, owned by Strickland Metals (ASX:STK) in Serbia surely appeals to a major given the scale that could grow to 10Moz AuEq before long (Ed: Zijin is a large player in the geographical region). In the silver space, Andean Silver's (ASX:ASL) high grade and existing infrastructure offers appeal against a backdrop of global silver M&A deals (PASS-NYSE and MAG-TSX; DPM-TSX and ADT-ASX; AG-TSX and GATO-TSX). At the smaller end of town, companies like Astral Resources, Caprice Resources (ASX:CRS) and Great Boulder Resources (ASX:GBR) offer potentially accretive ounces to their neighbours, in our view. In West Africa, where many a M&A deal has taken place in recent years, we flag Predictive Discovery (ASX:PDI) and Turaco Gold (ASX:TCG) as having severe M&A appeal and wouldn't write off the prospect of seeing more strategic investments in smaller explorers such as Many Peaks Minerals (ASX:MPK) or Asara Resources (ASX:AS1). In fact, the whole global junior and emerging space is probably open to further strategic investments rather than pure takeover. We've seen Lundin, Montage and Zijin take this approach recently and to good effect. Hedley Widdup – Lion Selection Group Antipa Minerals (ASX:AZY) Given the amount of airtime this one has got I risk being Captain Obvious. The summary is that Greatland have done a wonderful job of outlining their plan to rejuvenate Telfer, which will benefit immensely from additional ore sources. Telfer is a big process plant, so anything that can be brought in probably needs to deliver volume as well. Antipa's Minyari contains a lot of its inventory in a single footprint, so offers up what appears to be both volume and compatibility. With Greatland set to list on ASX and suddenly become a big new domestically listed and focused gold miner, at a capitalisation that will likely see it gain index inclusion rapidly, you would expect them to have strong paper. I have to declare, Lion is a shareholder in Antipa. Bellevue Gold (ASX:BGL) This is also a name that has had chins wagging all over the place, and I think surrounds a notion that the market had a level of tolerance for commissioning issues, but Bellevue has taken too long and it's beginning to look like the ability to deliver large tonnage from a narrow vein underground at high grade is more challenging than hoped. The sport here appears to be in who the buyer might be, almost as if the chattering classes have decided a change of control is assured. Catalyst Metals (ASX:CYL) has not been concealing growth interest, although hasn't engaged in company-scale growth M&A since two deals to reunite the Plutonic field – their ambition would appear to be commensurate with a Bellevue sized target. Regis Resources (ASX:RRL) has been fingered for acquisitive interest and is probably seen as one of the most motivated project acquirers in the gold space aside of strategic neighbour consolidation. And I have wondered for a while if it is foolish to rule out Develop Global (ASX:DVP) – who spectacularly ruled out gold on the sidelines of Diggers and Dealers several years back ('gold isn't green, I'm sorry but its not') and is hitting its straps at its own project in NSW. My suspicion arises from (former Northern Star boss and now Develop MD) Bill Beament's personal history of buying projects he had previously operated at as a contractor. What would surprise us? At the moment the most deal speculation I read is around gold miners who have been piling in cash, buying up undeveloped growth options cheaply or bigger sized strategic deals like BHP for Anglo, Rio for Glencore etc. Who else is well funded, and what could they be looking at? With the competition between Trump and China leading to a renewed focus on rare earths and antimony, I think M&A interest may be relevant where deposits have either grade or scale or both, where they are located in safe jurisdictions and offtake is available. And to be clear, these are a few examples of a larger population, that might suddenly begin to look important as geopolitics changes. In rare earths, Critica (ASX:CRI) – resource stage which might make it a bit early for strategic corporates but it's very, very big, high grade and strongly located in WA's Gascoyne region (Lion owns some Critica). In antimony, Warriedar Resources (ASX:WA8) – very large antimony resource has emerged rapidly and largely from un-assayed historic holes that were drilled for gold and Southern Cross Gold (ASX:SX2) – it would be rare, but not unprecedented for a pre-resource situation to become a target. I am sure the high grades of antimony have been recognised. At Stockhead, we tell it like it is. While Astral Resources, Antipa Minerals, Caprice Resources and New World Resources are Stockhead advertisers, they did not sponsor this article. The views, information, or opinions expressed in this article are solely those of the fund managers, brokers8 and analysts and do not represent the views of Stockhead. Stockhead does not provide, endorse or otherwise assume responsibility for any financial advice contained in this article.

Opposition Leader Brad Battin committed to winning state election
Opposition Leader Brad Battin committed to winning state election

Herald Sun

time4 hours ago

  • Herald Sun

Opposition Leader Brad Battin committed to winning state election

Don't miss out on the headlines from News. Followed categories will be added to My News. It's been a tumultuous first six months for Opposition Leader Brad Battin. Once asked what knocks a government off course former UK Prime Minister Harold Macmillan famously said: 'Events, dear boy, events'. From his controversial cruise holiday, to his deputy being embroiled in a parliamentary allowances scandal, internal turmoil inside his party room, factional warfare and the never-ending saga that is the ongoing feud between John Pesutto and Moira Deeming, events have made the first six months of Battin's leadership a rough ride. Despite best efforts and intentions the party has slipped backwards in the polls, only narrowly, for the first time in more than 12 months and in recent weeks serious questions about whether he will lead the party to next year's November election have been raised among MPs and party members. There's no plan to topple him, numbers aren't being counted, and talk of change right now is only hypothetical. But Battin accepts the talk is happening and says while frustrating, it makes no difference to how he tackles his job. Battin has the will, the belief, and the want to succeed in spades, and believes his Opposition has become increasingly effective, even if admitting his focus couldn't have been wholly on the task of forming government over the past six months. Most of that was because of inherited, rather than created, problems. Less than 24 hours after he helped orchestrate a deal to save the political career of John Pesutto – via a $1.55m Liberal Party loan that will allow him to pay the $2.3m he owes Moira Deeming and avoid bankruptcy – Battin told the Sunday Herald Sun he can finally focus on winning government. 'It's now time to start talking about our vision and what we want to see for Victoria,' he said. 'We know that Victoria has struggled for far too long under this Labor government. 'We want to return Victoria to what it should be, which is to have fairness, opportunity and safety for everyone. 'And I think it's really important that we start to get back to the things that are important to people at home.' Battin knows his party has for too long failed to resonate with Victorians as its MPs waged war on each other instead of on the Labor government. But he feels there's been a shift under his watch, and points to a series of policy backflips by Jacinta Allan to prove his point. 'A good opposition obviously makes a more accountable government and we can already see we're having an impact,' he said. 'They're reversing some of their bail laws because they know we're holding them to account. 'We are being more effective, and I think the team knows that. 'So now we just got to get it so the only thing we're talking about is going to the next election.' The Coalition need to win 16 seats, and lose none, to form government at the 2026 election which will take massive swings against Labor across the state. A perceived policy vacuum remains a major stumbling block in achieving that plan. For years the Liberals have defined themselves by what they oppose rather than what they stand for. Battin talks in broad statements about his vision for Victoria, but little by way of detailed policy has been put forward, to the frustration of some of his party room. Battin is also facing a generational problem. Young voters have all but turned away from the Liberals because they see a party fixated on culture wars and nostalgia, not cost of living or climate. Battin knows the Liberals won't win again until they reconnect with voters under 40, and his challenge his dragging some of his party room with him. He sees housing and cost of living as election winning issues, followed by crime. 'We want to unlock the opportunity for home ownership. We know we're going to grow the economy, whether that's via cutting taxes or in creating opportunities for investment,' he said. 'We want to reduce the cost of living … and make sure we can get gas back into the market. 'Education is a big issue, and the health system, we're seeing it daily, people are genuinely dying now because of the state of the health system.' To keep on message and sell his Opposition as a viable alternative government Battin knows he needs to unite his team – a problem which has plagued many of his predecessors. He plans to do it by meeting with each and every MP in his stable and talking to them about their goals for government. 'I will speak to every single member and as when you first came into parliament, what did you say in your maiden speech, what were you going to deliver and can you do it from opposition? 'If the answer is no, then it's time to focus on getting into government. 'I believe that once we've had the conversations with people and they can get the realignment, I think people want to win. 'People in our party are sick of not just being in opposition, but sick of the worst government in Australia's history. 'You've got to find the common goal. It's like any football club, any sports team, any business.' That goal, forming government, has been seemingly too lofty an ambition to unite the team for much of the past decade, but Battin has faith he can turn that around. Even if he is facing accusations of picking sides in the feud between Pesutto and Deeming – a claim he vehemently rejects. The perception has put him off-side with a number of colleagues who he will need to placate if he stands any chance of party unity moving forward. Asked if he wants to see Mrs Deeming preselected to run in 2026 – a move which would all but secure her a second term in parliament – Battin says only that he wants to take his current team to the next election. It is a tacit endorsement. 'I know the reasons I got into politics, I know the things I want to deliver, and I can't do them from opposition,' he says. 'Sometimes it just takes that reminder again to say, we've only got 16 months. It is time now to start focusing on those outcomes, and to get those outcomes you need to win an election.'

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