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Insmed Incorporated (INSM)

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28.66-0.18 (-0.62%)
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  • J
    Joe Blow
    Joe Blow
    I also have concerns.What if the 2019 was leaked to CNBC.I have been here too long but Europe and the US trials be done by a certain date almost all never came true.2019 would mean the company already knows the FDA wont review quickly but like every thing else.No shortcuts to approval. I've been hearing that for 4 years from approval for a phase2 trial in the US ( add 3 years) to the EMA dog and pony show which Insmed wont even apply to until 2020 this company pumps up expectations and then shareholders are left holding the bag for years.Joe says a long time down while the FDA puts arikayce under a microscope Oh that cant happen ! Oh Yes it can! I just realized the repercussions of arikayce failing the secondary 6 min walk.Lewis said at a chat that the FDA would probably want both endpoints met to grant a sub part H.so another long delay and charade by traders
    wouldn't surprise this beaten up shareholder.
  • E
    Endo
    Endo
    Insmeds PR "plans" to do a lot of things
    Cleverly worded 6 min walk successful but that was only for those that converted. I like the way Insmed has new paid experts at their PRs
    We know that Insmeds NIH advisers including former INSM star pulmonologist Dr. Ken Olivier (spokesman for the P2 ) left Insmed because of the drugs worrisome side effects profile. Joes comments should be heeded
  • l
    linda
    linda
    Endo Item #!
    The type of filing will tell us a lot. If the FDA response is hidden in a PR or 8k and the NDA is regular form there are questions about the dropout rate. Insmed has already doubled the price of the drug which tells you they known the market shrunk with the results (failed secondary). If there is an accelerated review the label may be more favorable
  • M
    Michael
    Michael
    Should we expect a far higher share price by the end of the year?

    V.2 - Minor amendments

    Quotes from Dr. Kevin Winthrop's observations about MAC therapy during the Investor Day event (not necessarily in this order) -

    None of the first-line drugs are approved.

    NB: The regimen for standard infection is a Macrolide / Rifampin / Ethambutol triple combo.

    Most of my patients can't tolerate all three. Almost no-one likes Rifampin. Rifampin reacts with about thirty different drugs out there if I had to guess - a lot of the medicines people are on. It's a very difficult drug to use.

    And there's a lot of older people particularly who do not tolerate it.

    NB: Common side effects of Rifampin include nausea, vomiting and diarrhea.

    Even if we start with the three drugs I mentioned we quickly lose one or more of them in a large percentage of individuals. Which leaves a hole in the regimen.

    The drugs are there to protect themselves. M.Avium is highly drug-resistant. We treat with multidrugs to diminish the chance that the bugs get resistant to these antibiotics.

    For cavitary disease we add amikacin. IV amikacin is probably the most potent drug we have, it's just people can't tolerate more than a couple of months through IV. It's just too toxic.

    We'd all be interested to see if ALIS would be useful in the first-line therapy for all these patients. I could see using a drug like this right away in a lot of patients - in fact in most patients.

    NB: Immediate clarification by Will Lewis - Those are decisions a physician will make. (Promotion of off-label use is prohibited).

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

    Will the Payers approve the off-label use of ALIS in place of the off-label use of Rifampin in the standard regimen?

    Improved compliance / greater efficacy = earlier eradication of the infection = shorter duration of therapy = reduction in overall cost of therapy.

    The duration of therapy for the standard MAC regimen ranges from eighteen to twenty-four months. As ALIS delivers concentrated amikacin directly to the site of the infection, the Payers will surely be alive to the possibility of a duration of therapy much closer to the six months recommended for the standard Tuberculosis regimen.

    Furthermore - as up to 33% of patients currently die within five years of diagnosis of MAC infection, it's clearly in the Payers' interests to prolong their lifespan so that the Payers receive more in Plan payments.

    From the Investor Day slides -

    ..... Estimated 65,000 - 80,000 people in the US with lung disease caused by MAC, 60% of whom will be treated.

    ..... Estimated 25% - 30% non-responders to the standard regimen.

    The ultra-conservative estimate is an initial 9,750 treated patients (65,000 x 60% x 25%) in the US for whom ALIS now seems highly likely to be an FDA-approved therapy.

    If Insmed is supplying ALIS to 10,000 patients by the end of 2019, a conservative price of $75,000 pa will generate sales of $750 million.

    The average biotech valuation sales multiple is currently 5.67 - $4,252,500,000.

    $4,252,500,000 divided by 77 million shares would mean a share price of $55.23 by the end of 2019 - consistent with the 2017 Offering price of $28.50.

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

    So is there any reason for fund managers and other professional investors to pay more than $28.50 this year?

    The answer lies in their private valuation, the basis of which is usually anticipated earnings over the first TEN years of sales.

    In addition to the immediate off-label use of ALIS in MAC infection contemplated by Dr. Winthrop, the professional investors will also anticipate off-label use for infections other than MAC infection in Non-CF Bronchiectasis.

    A 2008 survey suggested over 250,000 people in the US with Non-CF Bronchiectasis. The prevalence of Bronchiectasis (including CF) in the UK in 2013 was estimated at around 500 in every 100,000 adults. At that rate there would be 1,250,000 adults in the US with Bronchiectasis.

    The estimates of MAC infection do include MAC in Non-CF Bronchiectasis. But Pseudomonas is far more common - an estimated one-third of people with Non-CF Bronchiectasis suffering chronic infection.

    ALIS would kill two birds with one stone.

    Looking further ahead, Insmed's inhaled liposome delivery technology could be a game changer in the war against Tuberculosis.

    From the World Health Organisation -

    Ending the TB epidemic by 2030 is among the health targets of the newly adopted Sustainable Development Goals (SDG). To sustain progress beyond 2025 and achieve the SDG 2030 and End TB 2035 targets, additional tools must be available by 2025.

    In particular, a new vaccine that is effective pre- and post-exposure and a safer and more effective treatment for latent TB infection are needed to reduce the number of new TB cases arising from the approximately 2 billion people worldwide who are infected with M.tuberculosis, as well as better diagnostics and safer and easier treatment including shorter drug regimens for TB disease.

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

    1. Safer and easier treatment including shorter drug regimens for TB disease by 2025 -

    In 2015, 10.4 million people fell ill with TB and 1.8 million died from the disease.

    The current four-drug regimen for standard (non-resistant) TB is based on two main drugs - Isoniazid and Rifampin, taken for six months - in combination with Ethambutol and Pyrazinamide for the first two months.

    The Rifampin side effects are a major problem in TB management. Sub-optimal levels of antibiotic promote antimicrobial resistance.

    In 2015, 480,000 people developed TB resistant to both Isoniazid and Rifampin. A further 100,000 people required treatment for Rifampin-resistant TB.

    The recommended regimens must include one of the following injectable antibiotics: Amikacin, or Capreomycin, or Kanamycin - all of which are very toxic.

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

    2. Safer and more effective treatment for latent TB infection by 2025 -

    An estimated two billion people are carrying latent TB infection. TB will remain a serious threat to public health for as long as there is a single person on the planet walking around with latent infection.

    The Centers for Disease Control and Prevention (CDC) website lists four recommended regimens for latent infection - one of which is Rifampin monotherapy, once daily for four months. As people with latent infection don't suffer any symptoms, are those regimens administered at gunpoint?

    The site also warns -

    [ Due to the reports of severe liver injury and deaths, CDC recommends that the combination of rifampin (RIF) and pyrazinamide (PZA) should not be offered for the treatment of latent TB infection. ]

    But the recommended regimen for ten million people each year who get normal TB infection includes both of these drugs for the initial two months. There are no safer alternatives.

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

    Replacing Rifampin with ALIS in the standard regimen would be safer - and would reduce the incidence of drug-resistant TB, which is far more difficult and expensive to treat. Only 52% of patients are successfully treated.

    Therefore replacing the injectable antibiotic with ALIS in the drug-resistant regimen seems a no-brainer, especially given Dr. Winthrop's comment about the toxicity of IV amikacin.

    However 95% of TB infection occurs in low and middle-income countries, where the cost of ALIS is likely to be prohibitive in 2019. But one would expect a substantial increase in the funding of TB management long before 2029.

    Avoidance of toxicity would not be the only advantage of inhaled liposome delivery of TB antibiotics. An individual whose sputum no longer contains live mycobacteria after a few months is an individual who can no longer fuel the epidemic.

    None of this will be news to the professional investors. Their estimates of Insmed's earnings over the next ten years would be of no value unless they included revenue other than that anticipated from the initial approved use of ALIS.

    The higher those estimates, the more they will be prepared to pay for the shares this year.

    (Scroll down for bonus material)
  • P
    Predict
    Predict
    Inst Own 75.90%
    I find this suspicious.If the offering sold out quickly there surely would have been one of the 5% Institutions? Why have there been no SEC filings?Has Goldman purposely hid who bought? Games not over
  • F
    Fghyujk Sdfghj
    Fghyujk Sdfghj
    Terry will not say the price or possible scenario.His comments about IV iplex etc are polite comments to my wife__)) Make it of what you will. Terry enjoys wide gratitude in a paid trading room.He has been very active the last few months and we are talking big money.Quite a few took the INSM buy "with both fists" at $11.9.... .sell at $ + 29+ just over a month trade.-=-==-=-
    Karen, I will politely ask board screamer kinkey-boots to please stop with the spam and ridicule of posters elsewhere. They may not be as experienced or knowledgeable of Insmed but they are seeking answers. I will agree the recent spat of iplex hype is mostly wrong.What needs to be said is that iplex with the exception of the short lived approval of short stature iplex was never really trialed. From MDD to ALS to HARS the trials were exploratory.( under the guise of a Phase2a..... I wrote of this to a poster that the ROP would fail .It did and now ! Voila! ..... a new 5 year exploratory trial has been given the FDA fasttrack seal of ..CYA ... Just like arikayce got 5 years ago! - that is before the FDA mandated a 2 year delay ! and a real trial.

    A iplex Italian and US compassionate care programs (MMD ALS) resulted in little to expand iplex..Insmed trying to keep on a happy face told shareholders that they were"designing a trial for severe insulin resistance! It never happened.
    IGF-1 is similar to insulin and was shot down in the markeplace because of a hypoglycemic side effect.... sales were miniscule
    There is no 2009 iplex left with that approval hence there is no approval.

    Even if you dont have the sources that have been available ( Napo etc) all you have to do is follow the money. IV is a group of very poor investors that never accepted Iplexs failure. Everyone else moved on. If any indication had showed promise ..and none did.. I guarantee an iplex product trial and investment would have happened long ago. To think that Investment money is being cruel or not allowing Insmed etc you are foolish .......money would have had a market.
    The most promising ROP garnered 25M for all rights.If you are holding your breath for another rights deal well then Good Luck

    My call on the new low and what I think happens next is for our trading room and not for these jerks. I have suggested all avoid IV... its bad for your investment knowledge Recent threads have validated this in spades. Look at the sentiment on the board before and after the results .... better than Math!..... so maybe there is some value.
    Now @#$% @%#* #$%^
    Best!
    Terry

    ( remember arikayce "sales in France ! ))) =1 patient .... give Lewis his due. He got Goldman Sachs A takeout price will benefit guess who ? ....
  • F
    Fud
    Fud
    Our Favoritefaggt Fuddy is here! "Michael"
    did our gayby finally make a buck?
  • K
    Kinky
    Kinky
    deleted from this morning
    zake1 wants to know why we have not heard from Insmed regarding this ! ! \ \ "SERIOUSLY! \ \ Re: Shire Receives FDA Fast Track Designation for SHP607 for the Prevention of Chronic Lung Disease in Extremely Premature Infants\
    ITS NOT INSMEDS \ \ \ ITS SHIRES ! DUHHHHHHHhhhh
  • E
    Endo
    Endo
    Kinkys taunts aside Why would this board be hyping iplex and Shire?This is not relevant to shareholders of INSM
    Why would Insmed spend money when they have a proven technology in Arikayce
  • N
    Nick Danger II
    Nick Danger II
    $ARDM conversation
    We should be higher then $INSM currently if all things equal.
  • p
    popperj
    popperj
    Buy INSM...for Iplex.......
    MENLO PARK, Calif., Sept. 21, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the VELOCITY Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (GHD) did not meet its primary endpoint of non-inferiority.

    Non-inferiority versus daily growth hormone was not demonstrated in the intent to treat (ITT) population for the primary efficacy variable, height velocity (HV) at 12 months. The 12-month HV for ITT patients receiving somavaratan twice monthly was 9.44 cm, versus 10.70 cm for those receiving Genotropin® 1 daily. Non-inferiority was defined as the lower bound of the two-sided 95% confidence interval of the difference between somavaratan and Genotropin HV greater than or equal to -2.0 cm/year. In the ITT study population the lower bound of this confidence interval was -2.3 cm/year.

    In the per protocol population (PP), non-inferiority was demonstrated. The 12-month HV for PP patients receiving somavaratan twice monthly was 9.71 cm, versus 10.63 cm for those receiving Genotropin daily.

    Somavaratan was well tolerated with treatment discontinuation rate lower than for the Genotropin arm. No new emergent safety signals were observed.

    “We are very surprised and disappointed to learn the outcome of the VELOCITY trial. Somavaratan showed height velocity in the range we had hoped, but it was not sufficient to demonstrate non-inferiority in this trial,” stated Jay Shepard, President and CEO of Versartis, Inc. “We have done an initial analysis of the top-line data and are continuing to thoroughly review the results to gain greater insight into the trial outcome. We plan to provide a corporate update later this year. I would like to thank the investigators, pediatric GHD patients and families that participated in the VELOCITY trial.”
  • l
    linda
    linda
    my post from yesterday on filing protocol was deleted
  • K
    Kinky
    Kinky
    ALL FALSE ! ZAKE! is lying \ There is a whole lot more here than I remember...first of all..these are some of the issues Iplex was approved for, and found safe...think of all the people that suffered because of this
    1.54 “Named Patient Indications” means myotonic muscular dystrophy, HIV related Adipose Redistribution Syndrome (HARS), retinopathy of prematurity, recovery from burns and trauma, and recovery from hip fracture.
  • l
    linda
    linda
    Anyone commenting about possible revenues in Q1 2018 immediately show they do not have any understanding of the issues at hand.
  • J
    Joe Blow
    Joe Blow
    SEC Insider SHAROKY MELVIN MD sold 50,000 shares
  • A
    Anonymous
    Anonymous

    MDNA.TO (MC C$36 M) (Cash C$20 M) Hot Cancer Play with important Results in Q1 that could lead to FDA approval =1500-2000% UPSIDE Potential ! RALLYYYYYYYYYYY

    Brutally cheap and completely unknown canadian biotech stock with minimum 10 bagger potential . Positive Phase 2 results in recurrent glioblastoma which expected in Q1 2018 could lead to accelerated approval which would be a HUGE MAJOR milestones for this undiscovered low float stock . This company has brutally low valuation of only $36 million and most of that in cash $20 million which is enough untill Q1 2019 . This stock at $1.50 is a lifetime opportunity and we could see $15-20 easily on Positive 2 results and FDA approval .GL

    Medicenna Therapeutics (MDNA.TO)

    Market Cap C$36 Million
    Cash : C$ 20 Million << enough untill Q1 2019
    Price : $1.50

    Shares Out: 24.3 Million ( 15.5 Million shares held by Insider alone )

    Medicenna Therapeutics (TSXV: MDNA) CEO: Our Drug Has Potential for Phase 2 Approval
    https://smallcappower.com/videos/companies-to-watch/medicenna-therapeutics-tsxv-mdna/

    New Presentation
    http://s21.q4cdn.com/710416940/files/doc_presentations/2017/Medicenna-Corporate-Presentation-Q3-2017.pdf

    Fact Sheet
    http://s21.q4cdn.com/710416940/files/doc_downloads/fact_sheet/Medicenna-FS-Q1-2017-v2.pdf

    Insider Ownership :

    Aries Biologics, Inc. 5 500 000
    Rosemina Merchant 5 050 000
    Fahar Merchant 5 050 000
    Elizabeth Williams 5 300
    Chandrakant J. Panchal, PhD 1 000
    Trevor P. Wong-Chor 714

    Medicenna Therapeutics (TSXV: MDNA) CEO: Our Drug Has Potential for Phase 2 Approval
    Medicenna Therapeutics Corp. (CVE:MDNA) President & CEO Fahar Merchant said the Company received a large grant from the state of Texas.
    smallcappower.com
  • K
    Kinky
    Kinky
    John Dsouza \ " as they provide further updates on data and recent submission" FALSE\ GO BACK TO INVESTOR VILLAGE
    THERE WAS NO SUBMISSION
  • C
    Chloe
    Chloe
    I think INSM might have reached its upward limit and that a pullback may be possible. have you guys heard of awe-some*sto-cks. i started receiving their allerts and so far i am happy.
  • J
    Jay
    Jay
    Any chance PPS will fall to fill the big gap ?
  • K
    Kinky
    Kinky
    Why Investor village is dangerous.zake asks the "Piano master" to opine on something he then makes up a story and longtime stupid "JAD9000" chimes in JAD9000 . I agree with prior posts that we should be selling in the US by Q1, 2018."
    It is important to realize that all these posters are simply making up stories without substance.Laugh at the $50 dollars soon but the timeline in anyones investment should be important and simply put these people are lying STAY THERE!