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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Polarean Imaging Plc | LSE:POLX | London | Ordinary Share | GB00BF3DT583 | ORD GBP0.00037 |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.30 | 4.20 | 4.40 | 4.30 | 4.30 | 4.30 | 967,177 | 08:00:04 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Surgical,med Instr,apparatus | 1.03M | -13.91M | -0.0644 | -0.67 | 9.28M |
Date | Subject | Author | Discuss |
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02/7/2020 12:25 | I think priority review is a significant possibility. Especially as we are not talking about a product that has any risks or dangers. The only real question is 'does it work and assist diagnostics in pulmonary?'. Pretty simple answer! As I think I mentioned before once we get the application in I think their commercial people will be taking pre-orders (subject to FDA approval). The company probably will not announce them as they arrive? But could make for a super RNS alongside approval - next year. | idiot441 | |
02/7/2020 12:13 | What's brought this on? I thought it would stay where it was until US had intimated that it had passed their acceptance, i bought these on the knowledge it would probably be my slowest burner of the lot...it's turned into the opposite :) | aberloon2 | |
02/7/2020 11:38 | Nice bit of share buying activity for a change. | gregb | |
27/6/2020 15:42 | A well-known spin-out is Vodafone(VOD), which was spun out from Racal Electronics, and now has a market capitalisation of over £30 billion. | hedgehog 100 | |
27/6/2020 15:32 | The fact that POLX is a spin-out is a major bull point, as spin-outs on average greatly outperform the market as a whole. - "3,484 views|Mar 5, 2019,10:38am EST Spin-Offs Outperforming The Market This Year Joe Cornell Contributor Markets You can beat the Street. At a time when many professional investors lament that the proliferation of ETFs and widespread use of screening techniques have made it harder to find bargains in the stock market, one simple investing approach continues to outperform: spin-offs. Spin-offs have long been a fruitful investment area; a number of academic studies show that they historically have generated far better returns than the overall stock market. A spin-off occurs when a corporation issues stock in a subsidiary to its shareholders to create a new public company. A related corporate event is an IPO carve-out, through which a company sells the public a stake in a unit, while retaining the rest of the division. (Sometimes, the remainder is later distributed to shareholders). The Bloomberg U.S. Spin-Off Index, composed of companies spun off from larger companies within the past three years, has outperformed the broader market by nine percentage points since the start of the year through Tuesday (February 26th). The 35 member index contains equities with a value over $1 billion that were spun-off from U.S. companies. ..." | hedgehog 100 | |
25/6/2020 06:34 | GE Healthcare have spun out lots of companies - many going on to be very successful. GE core businesses in lots of trouble so I believe they decided to focus on them - would have done better to have stuck with healthcare! | idiot441 | |
25/6/2020 06:06 | One has to mask the question Why did the original company that invented this GE Healthcare decide not to run with it ? Did they see a cheaper quicker bedside alternative coming along that could do a similar job at a fraction of the price ? | buywell3 | |
24/6/2020 22:16 | Any radiologist here? I am trying to get more information on this. Looks solid to me but I am not MD. | arealdetective | |
24/6/2020 16:26 | Sorry just seen the link | lukehold | |
24/6/2020 16:26 | Interested in this did you email IR with those questions mcfly would be interested to hear what the moat is | lukehold | |
24/6/2020 15:35 | Thanks Hedgehog. | mcfly79 | |
24/6/2020 15:08 | Bought in today at 26.5p in preparation for Q3 | pauliewonder | |
24/6/2020 14:25 | "Coronavirus: Warning thousands could be left with lung damage By Jim Reed and Sophie Hutchinson BBC News 23 June 2020 Tens of thousands of people will need to be recalled to hospital after a serious Covid-19 infection to check if they have been left with permanent lung damage, doctors have told the BBC. Experts are concerned a significant proportion could be left with lung scarring, known as pulmonary fibrosis. The condition is irreversible and symptoms can include severe shortness of breath, coughing and fatigue. NHS England said it was opening specialist rehabilitation centres. ... "With all these cases, we can't say for certain at the moment," said Dr Sam Hare, an executive committee member of the British Society of Thoracic Imaging and advisor to the Royal College of Radiologists. "But usually with a virus or infection at six weeks, you would expect the scan to have returned to normal. It hasn't and that's the worry." Like other Covid-19 patients who have been discharged from hospital, Mr McHugh will need another scan at 12 weeks to see if the suspected scarring on his lungs has deteriorated. "In the six-week scans we're seeing, so far I would say between 20% and 30% of patients who have been in hospital appear to show some early signs of lung scarring," says Dr Hare, who helped draw up NHS radiology protocols to diagnose Covid-19. ... Lung fibrosis cannot be cured because scarring in the lung tissue is permanent. But new drugs can slow down the progression of the disease and even stop it completely if detected in time. "We now need to understand how big the problem is and when we should intervene with treatment," said Prof Gisli Jenkins, of the National Institute for Health Research, who is running assessment clinics for those discharged from hospital with Covid-19. ..." | hedgehog 100 | |
24/6/2020 14:15 | Mcfly79, From POLX's February 2020 investor presentation, which is viewable on its website: "• Strong and expanding IP portfolio and anticipated marketing exclusivity" "IP and Data Exclusivity • Strong IP Portfolio • Five-year data exclusivity post US launch • Potential additional 30-month extension in competing ANDA for Orange Book patents • Gas exchange and specific use IP provide additional barrier to competition" | hedgehog 100 | |
22/6/2020 12:35 | Hi all, I’m trying to understand what protection Polarean will have from competitors creating 1) a similar Xenon polariser device and 2) generic 129-Xenon gas to be used in the device. I assume Polarean’s protection will come from a combination of IP and knowhow (e.g. on the design of the polariser) and statutory drug protections (e.g. Hatch Waxman). I don’t have a good grasp on either, other than knowing that Hatch Waxman applies for 5 years (but I’m not sure if this apply to just gas sales or the device itself). Ultimately I’d like to know when we could realistically see a competitor product being sold, and what the process is for the competitor (is FDA approval required for a generic version of the gas? or for a copycat polariser device?). I know there are knowledgeable posters on this boards so I thought I’d try here first before emailing the company. | mcfly79 | |
20/6/2020 18:46 | hxxps://audioboom.co Around 8 mins 25s | idiot441 | |
20/6/2020 18:31 | POLX also featured in a new Vox Markets video yesterday: "Polarean Imaging, Bezant Resources and Paul Hill Justin Waite Vox Markets Podcast with Justin Waite 13:14, 19th June 2020 ... Richard Hullihen, Chief Executive Officer of Polarean Imaging (POLX) discusses the highlights from their final results and talks about the outlook over the next twelve months. Polarean, Inc. are revenue generating, medical drug-device combination companies operating in the high resolution functional magnetic resonance imaging market. The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent to visualise ventilation and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs. The Group operates in an area of significant unmet medical need and the Group's technology provides a novel diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate than current methods. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion. ..." Here are a few extracts (not quoted verbatim): • POLX's technology is the tool that's been missing in pulmonary medicine. • The existing technology struggles to elucidate pulmonary operation. • POLX's technology is obviously needed so much for COVID-19. • Passing the phase III clinical trials was the biggest achievement this year: a major milestone: unambigious success - couldn't be happier re. • FDA review timing from submission to approval: ten months, + 2 months for the Hatch Waxman (exclusivity) request. • There is some chance that the FDA approval process may finish sooner in the current COVID-19 environment. • POLX will also be looking at the possibility of an expedited FDA review. • Research users will inform and drive this expedited review request. • The vaccines and anti-viral sides of COVID-19 are being speeded up, so the diagnostics side should also be speeded up. • The next big milestone will be the FDA application submission. • POLX also has new orders to announce shortly, as soon as they are papered up. • Three good reasons to add POLX to a watchlist? i. POLX's technology is the ideal solution to a huge unmet need in medicine. ii. POLX's technology is all derisked. About US$60M. has been spent commercialising it. iii. Great management team and board with specialist expertise in the field. | hedgehog 100 | |
20/6/2020 17:47 | I don't imagine the Bracco interest will stop where it is, either. | supernumerary | |
20/6/2020 17:31 | On approval a lot options open up. License the product to a distribution partner. Sell the whole lot to Blue Earth. Debt funding. I'm not expecting more dilution especially if they get approval in under 12 months. | loglorry1 | |
20/6/2020 16:57 | Listening to the interviews I think there are several positives and I am happy with the progress even if we do not appear to have fast track to approval. 1. FDA meeting had no surprises and indeed helped ensure there should be no significant issues during the approval process. 2. POLX are on track to make application in Q3 - considering the FDA meetimg was April I think we may find that is in the first half Q3 and perhaps by end July? 3. Outcome due within 10 months and further 2 months to get exclusivity in usa for 5 years. 4. But even though it's not on a fast track we may find that covid encourages shortened timetable. Personally I think we could see a pleasant surprise with full approval (and exclusivity) confirmed by end May 2021 5. In the meantime POLX will continue to sell units for research... and some clinics may want to make sure they are ready by having it installed in time for approval. Another potential surprise as more firm orders ahead of FDA approval? These will have RNS 6. I am certain POLX will be taking pre-orders that are subject to FDA approval. Perhaps with some cash up front even? Clinics and hospitals etc will know there is going to be a queue once approval granted. Better to sign a pre-order/letter of intent to ensure place in queue. I do not expect the company to release info on those orders until approval - but immediately after FDA approval we may have a pleasant surprise of multiple units on order - perhaps 12 months capacity? More? Does anyone know what capacity they are gearing up for in 1st and 2nd year after approval? 7. Clearly post approval we can expect a fundraising to increase sales, marketing, manufacturing capacity etc. With a smooth approval process we might see a fundraise of say up to £10m? But by then price will hopefully be in the 75p to £1 range? | idiot441 | |
20/6/2020 16:00 | A new POLX video interview was posted on Proactive Investors yesterday: "Polarean Imaging in commercial launch mode for its lung function scanner Andrew Scott 07:18 Fri 19 Jun 2020 Polarean Imaging PLC's (LON:POLX) Richard Hullihen caught up with Proactive London's Andrew Scott following a recent pre-NDA meeting with the FDA. He says they're targeting the third quarter of this year to submit an NDA for its drug-device combination which uses hyperpolarised 129-Xenon gas MRI. By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function." Here are a few extracts (not quoted verbatim): • The pre-NDA meeting went pretty much as POLX expected. • No delays encountered re. Q3 FDA submission plan. • POLX's drug-device combination is being managed by the drug side of the FDA. • POLX are also seeking a FDA regulatory grant of market exclusivity in the US. • POLX are still selling & installing research equipment - they have an active pipeline - they'll be making a couple of announcements on that in due course. • POLX have non-research target customers for when FDA approval received. • POLX are already preparing for non-research commercial launch. • POLX are excited to be bringing pulmonary medicine in the US into the 21st. century. | hedgehog 100 | |
18/6/2020 09:45 | I think they're being very cautious in allowing 12 months for FDA approval - in the current pandemic, when doctors need all the diagnostic help they can get, it should be rushed through. | supernumerary |
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