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way2retire 15 posts  |  Last Activity: Aug 24, 2014 9:34 PM Member since: Apr 7, 2014
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  • Reply to

    Monday evening Insmed announced a share offer

    by word2thewize Aug 12, 2014 1:20 AM
    way2retire way2retire Aug 24, 2014 9:34 PM Flag

    It seems as though this Offering was viewed by some as the last opportunity to pay around $13 for a sizable number of shares.

    Although ten million shares were issued, there must have been a belief that the vast majority went to investors intending to hold them - either for the run-up to the launch in Europe or in anticipation of the announcement of a commercialization deal in Asia.

  • Reply to

    What will it take for XOM to reach $1,000?

    by way2retire Aug 1, 2014 7:24 PM
    way2retire way2retire Aug 23, 2014 8:44 PM Flag

    August 11 ... the Company guided via a preliminary prospectus that it intended to offer "up to $80,000,000 of shares", with underwriters having an option to purchase an additional $12,000,000 of shares within 30 days.

    August 18 ... the Company announced that it had issued $115,143,750 of shares, including the exercise of the option in full, at $11.25 per share.

    From the 18th to the 20th the share price didn't drop below $13.31, and was $13.50 or higher for most of that time.

    Doesn't that seem surprisingly generous on the part of the bidders - targeting ten million freshly issued shares yet giving new owners the opportunity to bank an immediate profit of 20%?

    The Company now has enough cash to fund operations at the current burn rate until the second half of 2016.

    Barring a problem with the application for marketing authorisation, Arikayce is due to be launched in Europe in the second half of 2015.

    Friday's closing price of $13.15 x 49,511,389 shares gives a present valuation of $651,074,765.

    12,000 patients x $30,000 would generate annual sales of $360,000,000.

    A multiple of 18.09 would deliver a valuation of $6,512,400,000.

    How likely is it that physicians treating at least 12,000 of the 12,000,000 with TB infection Worldwide will have the option to substitute Arikayce for one (or more) of the antibiotics contributing to the toxicity of the current regimens for normal TB and MDR-TB?

  • Reply to

    Monday evening Insmed announced a share offer

    by word2thewize Aug 12, 2014 1:20 AM
    way2retire way2retire Aug 18, 2014 12:09 AM Flag

    If the EMA grants accelerated assessment it will be confirmation it sees more here than just a better therapy for two small patient populations.

    At least we know for sure the EMA views Arikayce as a better way of using amikacin -

    [ The sponsor presented early clinical data showing better lung penetration and lower incidence of side effects as compared to the existing intravenous formulation. The Committee considered that this can translate into a clinically relevant advantage for patients affected by nontuberculous mycobacterial lung disease, as there are well-known and documented side-effects of the existing intravenous formulation that limit its use. ]

    The FDA's decision to request an additional study was myopic at best when one considers the decision to approve bedaquiline for MDR-TB, subjects to a confirmatory study, on the basis of Phase II culture conversion data.

    In that case the FDA was prepared to overlook an unexplained substantially higher mortality rate in the patients on bedaquiline compared with those in the placebo arm, with the following rationale -

    [ Nonetheless, treatment for resistant TB is complex, costly, toxic and prolonged, requiring at least 5 second-line drugs for up to 2 years. Second-line drugs include injectable drugs (amikacin, kanamycin, capreomycin) and oral fluoroquinolones (FQs) and other second line drugs; the optimal use of which has not been well studied in randomized controlled trials, and whose safety when used in concert with various doses and regimens is not sufficiently described. ]

    Given the FDA's expressed concerns regarding the unquantified safety risk posed by co-administration of several drugs in MDR-TB, one would have thought it obvious that the Arikayce NTM data are "reasonably predictive" of a clinical benefit in MDR-TB - promising the removal of one or more drugs with the potential to contribute to cumulative liver toxicity.

    I doubt the physicians treating these patients will overlook that aspect.

  • Reply to

    What will it take for XOM to reach $1,000?

    by way2retire Aug 1, 2014 7:24 PM
    way2retire way2retire Aug 10, 2014 8:31 AM Flag

    Fwiw the primary criterion for Accelerated Assessment, whereby the EMA undertakes to review an application for Marketing Authorisation within 150 days instead of the usual 210 days, is -

    "Applicants requesting an accelerated assessment should duly substantiate the request and in particular justify their expectation that the medicinal product is of major public health interest particularly from the point of view of therapeutic innovation".

    Given the widely acknowledged threat to public health posed by antimicrobial resistance, evident in the following resolution during the World Health Assembly in May -

    [ The delegates recognized their growing concern of antimicrobial resistance and urged governments to strengthen national action and international collaboration. This requires sharing information on the extent of resistance and the use of antibiotics in humans and animals. It also involves improving awareness among health providers and the public of the threat posed by resistance, the need for responsible use of antibiotics, and the importance of good hand hygiene and other measures to prevent infections.

    The resolution urges Member States to strengthen drug management systems, to support research to extend the lifespan of existing drugs, and to encourage the development of new diagnostics and treatment options. ]

    - it seems reasonable the EMA will deem inhaled liposome delivery a "therapeutic innovation", "of major public health interest", because of the potential to "extend the lifespan of existing drugs".

  • Reply to

    What will it take for XOM to reach $1,000?

    by way2retire Aug 1, 2014 7:24 PM
    way2retire way2retire Aug 8, 2014 9:42 PM Flag

    A recent snapshot of pharmas valued from $4 billion to $9 billion with positive earnings:

    Company ... Market value ... Multiple ... Q1 sales x 4 ... Q1 v 2013 ... Q1 v Q4

    PCYC ...... 9,260,454,870 ... 19.39 ...... 477,508,000 ....... +84% ......... -3%
    BMRN ...... 8,914,668,090 ... 14.71 ...... 606,208,000 ....... +11% ........ +3%
    JAZZ ........ 8,405,163,576 ..... 8.51 ...... 987,676,000 ...... +13% ......... +5%
    SLXP ....... 8,576,659,274 ..... 5.58 .... 1,537,496,000 ...... +65% ....... +49%
    TARO ....... 6,224,852,021 ..... 8.31 ...... 748,800,000 ........ +2% ........ -12%
    MDVN ...... 5,834,953,246 ... 16.73 ...... 348,756,000 ...... +28% ........ -10%
    QCOR ...... 5,672,223,163 ..... 6.24 ...... 908,416,000 ...... +14% .......... -6%
    CBST ....... 4,643,326,216 ..... 4.44 ... 1,044,932,000 ......... -1% ........ -13%
    UTHR ....... 4,475,054,784 ..... 3.87 ... 1,157,612,000 ........ +4% ......... +0%
    ITMN ........ 4,520,936,978 ... 37.33 ...... 121,096,000 ...... +72% ....... +18%

    Presumably some would have had higher sales multiples but for disappointing Q1 numbers. SLXP has a low multiple primarily because an acquisition delivered the bulk of the recent increase in sales.

    The confirmation that the EMA considers the Arikayce NTM data adequate evidence of efficacy opens the door also to off-label sales in MDR-TB (starting this time next year assuming accelerated assessment).

    Provided the strain is not amikacin-resistant, and wherever funding permits, Arikayce is an obvious substitute for injections known to cause kidney damage and loss of hearing.

    And the big players definitely wouldn't want retail investors to realize just yet that the risk/benefit argument for Arikayce trumps that of every antibiotic currently available to a Worldwide TB population of 12,000,000.

    12,000 using Arikayce at $30,000 per course would generate sales of $360,000,000. A market value of $4,643,252,400 - ten times the current valuation - would require a sales multiple of 12.90.

  • Antimicrobial-resistant pathogens now claim almost 50,000 lives in the US and Europe each year.

    The Wellcome Trust has warned -

    "We are failing to contain the rise of resistance, and failing to develop new drugs to replace those that no longer work."

    A progress report this May from the Transatlantic Taskforce on Antimicrobial Resistance noted -

    [ Developing new drugs alone will not be sufficient to address the growing resistance problem .... the efficacy of existing drugs needs to be preserved. Promoting the appropriate use of antimicrobial agents - use that maximises therapeutic effect while minimising the development of AMR .... is key to reducing selective pressure that leads to the development of resistance. ]

    The treatment of pulmonary infection by tablets or injections is far from ideal. Gradual delivery of antibiotics via the bloodstream creates the ideal conditions for antimicrobial-resistant bacteria to emerge.

    With infection by mycobacteria the problem is compounded by their ability to inhabit the pulmonary macrophages whose job it is to destroy bacteria. Infection by antimicrobial-resistant Mycobacterium Tuberculosis (TB) or Nontuberculous Mycobacteria (NTM) is treated for a minimum of eighteen months.

    However on June 18 the FDA awarded Breakthrough Therapy status after 29 of 52 patients with chronic antimicrobial-resistant NTM infection tested negative during treatment with amikacin delivered via inhaled liposomes, 15 of whom did so after just one month.

    Amikacin and the other aminoglycosides are classed as Crtically Important Antimicrobials by the World Health Organisation as they provide -

    [ Sole or limited therapy as part of treatment of ... Multi-Drug Resistant (MDR) tuberculosis. ]

    The analysts are still pretending not to have made the connection between efficacy in NTM and efficacy in TB.

    MDR-TB infection Worldwide is estimated at 630,000. Just 30,000 using Arikayce will increase the current market valuation by a multiple of ten.

  • Reply to

    Suggestions please

    by investing_007 Jun 21, 2014 7:33 PM
    way2retire way2retire Jul 13, 2014 11:45 AM Flag

    Assuming you don't believe in having all of your apples in the one basket - I suggest you could do a lot worse than to consider this March 31 comparison of that biotech we've been banging on about with sixteen "peer companies" selected by an outside consultant a few years ago as a basis for the Company's remuneration scheme -

    Institutional ownership / Symbol / Annual revenue ($)

    99% ... AEGR ..... 107,892,000
    92% ... CLDX ...... 1,664,000
    89% ... INSM ...... No revenue
    86% ... DYAX ...... 56,468,000
    83% ... SNSS ..... 7,980,000
    68% ... XNPT ...... 13,500,000
    64% ... KERX ...... 40,000,000
    63% ... FOLD ...... 1,824,000
    63% ... DSCO ..... 124,000
    58% ... ARQL ..... 10,704,000
    57% ... CRIS ...... 5,140,000
    44% ... VICL ....... 9,788,000
    37% ... AGEN ..... 2,884,000
    37% ... IMMU ..... 4,616,000
    30% ... CLSN ..... 500,000
    30% ... SIGA ...... 2,196,000
    ..8% ... ZLCS ...... 6,412,000

    Why does the only pre-revenue company on that list now have the third highest institutional ownership?

    If you're intrigued as to what these fund managers could be seeing in a pre-revenue company with a drug the analysts would have us believe will be used by two small patient populations, you'll get most of the way there simply by clicking on the pillsdontwork id further down this thread and reading the four most recent posts.

    Warren Buffett once remarked "If you wait for the robins Spring will be over". Five minutes of your time seems a small price to pay to ensure you're not missing out on a chance to buy another AAPL while it's still priced as an acorn.

  • Reply to

    What THEY don't want you to know about INSM

    by pillsdontwork Jun 18, 2014 10:56 AM
    way2retire way2retire Jul 13, 2014 10:37 AM Flag

    Another for the 'conspiracy theories' thread :-)

    The Company presentation notes that NTM lung infection is common in Asthma, COPD, Cystic Fibrosis and Bronchiectasis.

    In other words the target population are individuals with conditions which have weakened their pulmonary defence mechanisms - allowing bacterial infection.

    In most cases the bacteria are Gram-positive - routinely treated with beta-lactam antibiotics.

    Some bacteria are resistant to beta-lactam antibiotics -

    1. Gram-positive bacteria with evolved resistance (MRSA).

    2. Gram-negative bacteria (Pseudomonas, Klebsiella, Acinetobacter).

    3. Mycobacteria.

    In countries with TB epidemics the Mycobacterium is likely to be Mycobacterium Tuberculosis. In countries where TB is under control the Mycobacterium is likely to be one of 125-plus other species - two of which cause Leprosy, the others simply referred to as Nontuberculous Mycobacteria.

    Transave (the pre-merger company) chose Pseudomonas infection in CF as the initial test of its inhaled-liposome amikacin.

    Then the NIAID intervened, and suggested a parallel study in recalcitrant NTM pulmonary infection. To put this in perspective, that NTM sub-population is so small they had difficulty in finding 100 patients from the 50,000 in the US diagnosed with NTM lung infection each year.

    The ensuing study compared the standard triple-antibiotic regimen plus study drug against the standard regimen plus placebo.

    However proof of a superior risk/benefit profile in a small patient population with chronic illness which has left them immuno-compromised for so long that NTM in their lungs have had time to evolve resistance to the standard antibiotic regimen seems a small reward for a five-year collaboration.

    I don't believe the NIAID was particularly interested in developing a better NTM therapy.

    But developing a better amikacin therapy would be very much in the interests of both the NIAID and the FDA - given that ITFAR is co-chaired by the CDC, NIAID and FDA.

  • Reply to

    Anybody here heading for Dallas on the 28th?

    by erebdragons May 17, 2014 3:47 PM
    way2retire way2retire Jul 8, 2014 1:10 PM Flag

    Erebdragons, is there something you're not telling us?

    You on June 17:

    "Within two or three years the current approach to treating pulmonary infection will seem like something out of the Dark Ages."

    The British Prime Minister last week:

    [ Antibiotic-resistant superbugs threaten to plunge the world back to the "dark ages" of medicine, according to David Cameron, who pledged that the UK will lead a global effort to develop new drugs. The prime minister went on to call for a coordinated global response to the emergence of untreatable bacteria, which he described as one of the biggest health threats facing the world today.

    "This is not some distant threat, but something happening right now," Cameron told the Times. "If we fail to act, we are looking at an almost unthinkable scenario where antibiotics no longer work and we are cast back into the dark ages of medicine, where treatable infections and injuries will kill once again. That simply cannot be allowed to happen and I want to see a stronger, more coherent global response." ]

    You'd think it would be obvious that treating a pulmonary infection with concentrated antibiotic delivered via inhaled liposomes would allow far less time for antibiotic-resistant strains of bacteria to evolve - and that the WHO, CDC, FDA, EMA, TATFAR etc must view this inhaled amikacin as just the first step towards a key objective of phasing out delivery of pulmonary antibiotics by tablet or injection.

    Adoption of the Company's technology on such a scale would warrant a market cap somewhere north of $10 billion.

    The June 18 news that the FDA had added Breakthrough Therapy status to the earlier Qualified Infectious Disease Product status took the market cap up to $800 million. But over the last couple of trading days it's slipped back to $750 million.

    Why are so few investors connecting the dots?

  • Reply to

    Your Opinion Matters

    by thomasadams200 May 6, 2014 3:43 AM
    way2retire way2retire Jul 5, 2014 10:01 AM Flag

    Pillsdontwork - nice perspective from erebdragons. Perhaps inefficient delivery of antibiotics is the main reason for an estimated 630,000 currently being infected with MDR-TB.

    The British Prime Minister highlighted the AMR threat only last week -

    [ Antibiotic-resistant superbugs threaten to plunge the world back to the "dark ages" of medicine, according to David Cameron, who pledged that the UK will lead a global effort to develop new drugs. The prime minister went on to call for a coordinated global response to the emergence of untreatable bacteria, which he described as one of the biggest health threats facing the world today.

    "This is not some distant threat, but something happening right now," Cameron told the Times. "If we fail to act, we are looking at an almost unthinkable scenario where antibiotics no longer work and we are cast back into the dark ages of medicine, where treatable infections and injuries will kill once again. That simply cannot be allowed to happen and I want to see a stronger, more coherent global response." ]

    - and a TATFAR report in May emphasised the need for more efficient use of antibiotics in order to reduce the opportunity for resistant strains of bacteria to evolve -

    [ Given that few novel antimicrobial agents are likely to become available for clinical use in the short- to medium-term, the risks that AMR poses to public health are not difficult to fathom.

    Developing new drugs alone will not be sufficient to address the growing resistance problem ... the efficacy of existing drugs needs to be preserved.

    Promoting the appropriate use of antimicrobial agents - use that maximises therapeutic effect ... is key to reducing selective pressure that leads to the development of resistance. ]

    Perhaps ITFAR and TATFAR intend to use approval of this new inhaled amikacin to send a signal to the pharmaceutical industry to start work asap on inhaled liposome versions of all drugs used to treat TB and Gram-negative infections.

  • Reply to

    What THEY don't want you to know about INSM

    by pillsdontwork Jun 18, 2014 10:56 AM
    way2retire way2retire Jun 21, 2014 8:17 AM Flag

    I see the Nasdaq site finally lists an article with "Breakthrough" in the title. The analyst covers the Breakthrough Therapy status, and then notes -

    "However, in March this year, Arikayce failed to meet the primary objective of the phase II study of a pre-specified level for statistical significant difference in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the study."

    And your point is?

    The FDA decision confirmed that the failure to achieve statistical significance in the primary objective was rendered immaterial by the statistical significance in a secondary objective that turned out to be far more important.

    Elimination of the bacteria altogether clearly trumped a 'change in bacterial density' measure that accorded a one-point change equal weight to a seven-point change.

    This drug has now -

    1. Delivered the EMA Phase III success required for commercialisation in Europe and Canada to treat Pseudomonas infection in Cystic Fibrosis.

    2. Delivered (unprecedented) sustained efficacy in the follow-on phase of the EMA study.

    3. Been awarded QIDP status by the FDA for the treatment of Nontuberculous Mycobacteria (NTM) - a NON-contagious infection.

    4. Been awarded Breakthrough Therapy status by the FDA for the treatment of NTM - by virtue of success in a clinically-significant outcome measure.

    5. Been awarded Orphan Medicinal Product status by the EMA - by virtue of superior safety and efficacy to amikacin injection, a top-ranked therapy for an estimated 630,000 with MDR-TB.

    The analyst finishes with -

    "Arikayce is the lead candidate at Insmd which currently has no approved drug in its portfolio. Hence, the successful development of the candidate is crucial for the company's growth. We expect investor focus to remain on further updates on Arikayce."

    - and confirms a "Hold" recommendation.

    Yeah right. Do nothing - while his special clients are paying less than $20 for their shares.

  • Reply to

    GOOGL will delist from the Nasdaq on June 23

    by way2retire May 10, 2014 5:09 PM
    way2retire way2retire Jun 14, 2014 11:59 AM Flag

    The speculation as to whether or not GOOGL will be delisted by the Russell has now surely been trumped by the info you posted on the GOOG and GOOGL short interest.

    Between April 15 and May 30 the GOOG short interest decreased from 2,806,301 to 2,729,337. Over that same period the GOOGL short interest increased from 2,958,259 to 3,949,632.

    You would think an increase of 33.5% in one but not the other would have rung alarm bells with the retail holders of GOOGL.

    The reason it hasn't is the same reason professional investors have the luxury yachts and retail investors are forever late to the party and feeding off scraps - retail investors BELIEVE the share price. They need share price movement to reassure them they're making the right decision in buying or selling.

    Professional investors have always exploited that weakness, and are masters of the art of using the share price to make the tail wag the dog.

    They've managed to sell an extra million shares of GOOGL in six weeks whilst manipulating share price movement to conceal their activities.

    Retail investors will do nothing until the price starts to drop - and then still do nothing, because then they'll reason it's probably too late.

    The info Pills posted further down this thread says it all.

    Wanna make retail investors believe a $100 stock is a $10 stock? Easy - just use paid hacks to paint any good news as bad news, and sell enough shares at the key moments to nip any share price momentum in the bud.

    Now that the safety of inhaled liposome delivery has been established, what the FDA and medical community see is the first safe aminoglycoside antibiotic - a far more suitable therapy for Tuberculosis than anything currently available.

    But the analysts unite as one in pretending to be blissfully unaware of the TB angle. And share price movement completes the deception.

    Retail investors believe the share price - allowing professional investors to take full advantage of a once in a lifetime opportunity.

  • Reply to

    GOOGL will delist from the Nasdaq on June 23

    by way2retire May 10, 2014 5:09 PM
    way2retire way2retire Jun 11, 2014 6:11 PM Flag

    The minimum recommended Tuberculosis regimens are -

    1. Routine infection:

    Two months of isoniazid, rifampcin, ethambutol and pyrazinamide followed by four months of isoniazid and rifampcin.

    2. Latent infection:

    Nine months of isoniazid.

    3. Multi-drug-resistant infection:

    Eighteen months of at least five drugs to which the specific strain of bacteria remains susceptible - chosen in a recommended order of preference, the first of which is either an aminoglycoside or a polypeptide antibiotic.

    ---------------

    In the bedaquiline MDR-TB study the underlying 'standard of care' antibiotic combination was ethionamide, kanamycin, pyrazinamide, ofloxacin and either cycloserine or terizidone.

    Earlier this year the EMA granted the inhaled liposome delivery of amikacin Orphan Medicinal Product status. The recently published minutes from the relevant advisory committee meeting indicate that the committee proved receptive to a comparison with the historical safety profile of amikacin injection -

    [ The sponsor presented early clinical data showing better lung penetration and lower incidence of side effects as compared to the existing intravenous formulation. The Committee considered that this can translate into a clinically relevant advantage for patients affected by nontuberculous mycobacterial lung disease, as there are well-known and documented side-effects of the existing intravenous formulation that limit its use. ]

    Those "well-known and documented side-effects" are associated with the intravenous delivery of all aminoglycosides. Amikacin and kanamycin are both aminoglycosides.

    A logical extension of the EMA advisory committee's argument is that replacing the injected aminoglycoside in the MDR-TB regimen with the new inhaled aminoglycoside would also "translate into a clinically relevant advantage".

  • Reply to

    Anybody here heading for Dallas on the 28th?

    by erebdragons May 17, 2014 3:47 PM
    way2retire way2retire Jun 9, 2014 7:20 PM Flag

    Fwiw CRE are more of a concern to the federal task force than is MDR-TB. There is also a transatlantic task force - this is from their report last month:

    [ There has been a steady decline in the number of new antibacterial drugs entering the market place over the last few decades on both sides of the Atlantic.

    In the setting of continued development of AMR (antimicrobial resistance) and an insufficient pipeline to supply new options, the problem of AMR has become more pronounced.

    Because of the time and expense required to bring a new drug from the point of discovery to the market place, we need to respond to the current situation and prepare for the future.

    The goal of such efforts is to ensure that effective treatments are available to treat patients with serious infectious diseases, including patients with resistant organisms.

    The recent emergence and spread of Carbapenem-Resistant Enterobacteriacieae (CRE), such as

    gram-negative bacteria carrying the New Delhi Metallo beta-lactamase (NDM) or

    Klebsiella Pneumonieae Carbapenemase (KPC) resistance genes,

    are particularly worrisome because carbapenems are one of the last line antibiotic drugs to treat MDR infections ... The rapid spread of carbapenem-resistant bacteria is a serious threat to healthcare and patient safety world-wide ...

    Given that few novel antimicrobial agents are likely to become available for clinical use in the short- to medium-term, the risks that AMR poses to public health are not difficult to fathom.

    Developing new drugs alone will not be sufficient to address the growing resistance problem ... the efficacy of existing drugs needs to be preserved.

    Promoting the appropriate use of antimicrobial agents - use that maximises therapeutic effect ... is key to reducing selective pressure that leads to the development of resistance. ]

    Imo this new inhaled-liposome delivery must surely be viewed as a far more appropriate way of using amikacin to treat carbapenem-resistant Klebsiella.

  • Reply to

    Your Opinion Matters

    by thomasadams200 May 6, 2014 3:43 AM
    way2retire way2retire Jun 4, 2014 9:11 AM Flag

    I imagine every sputum culture-negative test will be viewed as significant by the FDA.

    Nontuberculous mycobacteria are environmental bugs - present in soil, and presumably therefore in tap water. Chances are most of us have NTM in our lungs. It's estimated that around a third of the people on the planet are walking around with Mycobacterium Tuberculosis in their lungs without suffering any ill effects.

    The immune system of a healthy person prevents bacteria from multiplying to a level where they cause illness. But the patients in this NTM study all had some sort of chronic underlying condition which meant their immune systems were unable to prevent the bacterial load from increasing to a level which made them ill. Unless the underlying condition can be cured they'll be permanently at risk.

    The patients had been consistently testing culture-positive despite their antibiotics for over six months prior to the study - in some cases for over two years. Proof that the bacterial load was beaten down to a level where no bacteria were present in the sputum is about as good as it gets with an environmental source of infection.

    And look at it from ITFAR's point of view. With a contagious infection, if there are no bacteria in the sputum the infection can't be passed on. Some of the patients tested culture-negative within four weeks.

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