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  • rehdvm2004 rehdvm2004 Nov 20, 2012 10:42 AM Flag

    Risk Assessment versus Slam Dunk

    Several points associated with a parallel post.

    The risk of finding precancerous lesions in the dog study is low. Not only because dogs are carnivores and metabolize fatty substances better than rats, but their lung field is about the biggest of any mammal that could be used for the study. Remember the dosing is based upon body weight, not lung size. Therefore a 560mg treatment dose gets more widely distributed in the lungs and is easier to clear. Also, the original dog study performed (probably) did not show the "foamy macrophages" because they did not look for such a lesion. The usual stains for tissue samples are Hemotoxylin and Eosin, but this time they are going use Sudan stains for fat deposits. This will allow a final determination concerning fat accumulation and carcinogenicity. But the bottom line is that this dog study will expedite filing the NDA for some type of use.

    As for Slam Dunk, this term must be excluded from being associated with any INSM clinical trial. This company has managed to mis-direct, under-perform and screw-up many opportunities with unique products.

    Iplex is now a an out-licensed, royalty only part of the INSM future. If you want to re-invest in Premiplex, wait for Premacure to go public. They will sell the stock to former INSM investors. Also watch for Hellstrom and Smith to publish more about these premies and their actual lung development and absence of ROP. The key here is that a premie of around 1000 grams gets to the PICU discharge weight of around 3.5 pounds in a period of time less than 60 days. That will be an endpoint that is undeniable. If these premies never develop ROP in two years of follow-up, that will be the a Slam Dunk for Premacure.

    Forget PCUT. That will never result in anything other than low cost treatment for ALS. But that model will never mean any more than a royalty for INSM. The PCUT original model of 2009 had INSM getting up to 39-43% royalty. But that is when INSM and BR were saying PCUT had "no skin in the game." Now INSM has only the skin from one finger in the game. You can figure out for yourselves which finger it is.

    So NTM is the biggest Arikace option. This is not an orphan drug indication, per se because the number of different strains of mycobacteria that are causing this infection are increasing as the methods of diagnosis improve. The following quote is on the wiki site for NTM:

    "The number of identified and cataloged NTM species has been increasing rapidly, from about 50 in 1997 to over 125 by January 2007. The surge is mainly due to improved isolation and identification technique.[4]"

    So NTM is the true direction for Arikace. It is virtually a efficacious treatment vacuum right now, but do not overlook the South Koreans and their clinical trial of inhalation amikacin solution.

    CF/Pa is an orphan treatment regimen that has an evolving cadre of antibiotic competition. This will be a numerical market entry. Not exponential. It will not be the basis of INSM moving up more than $20 per share in the forseeable future. That is with FDA and EMEA approvals.

    Sentiment: Hold

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    • by rehdvm2004.Nov 20, 2012 10:42 AM.Permalink
      .

      Several points associated with a parallel post.

      The risk of finding precancerous lesions in the dog study is low. Not only because dogs are carnivores and metabolize fatty substances better than rats, but their lung field is about the biggest of any mammal that could be used for the study. Remember the dosing is based upon body weight, not lung size. Therefore a 560mg treatment dose gets more widely distributed in the lungs and is easier to clear. Also, the original dog study performed (probably) did not show the "foamy macrophages" because they did not look for such a lesion. The usual stains for tissue samples are Hemotoxylin and Eosin, but this time they are going use Sudan stains for fat deposits. This will allow a final determination concerning fat accumulation and carcinogenicity. But the bottom line is that this dog study will expedite filing the NDA for some type of use.

      As for Slam Dunk, this term must be excluded from being associated with any INSM clinical trial. This company has managed to mis-direct, under-perform and screw-up many opportunities with unique products.

      Iplex is now a an out-licensed, royalty only part of the INSM future. If you want to re-invest in Premiplex, wait for Premacure to go public. They will sell the stock to former INSM investors. Also watch for Hellstrom and Smith to publish more about these premies and their actual lung development and absence of ROP. The key here is that a premie of around 1000 grams gets to the PICU discharge weight of around 3.5 pounds in a period of time less than 60 days. That will be an endpoint that is undeniable. If these premies never develop ROP in two years of follow-up, that will be the a Slam Dunk for Premacure.

      Forget PCUT. That will never result in anything other than low cost treatment for ALS. But that model will never mean any more than a royalty for INSM. The PCUT original model of 2009 had INSM getting up to 39-43% royalty. But that is when INSM and BR were saying PCUT had "no skin in the game." Now INSM has only the skin from one finger in the game. You can figure out for yourselves which finger it is.

      So NTM is the biggest Arikace option. This is not an orphan drug indication, per se because the number of different strains of mycobacteria that are causing this infection are increasing as the methods of diagnosis improve. The following quote is on the wiki site for NTM:

      "The number of identified and cataloged NTM species has been increasing rapidly, from about 50 in 1997 to over 125 by January 2007. The surge is mainly due to improved isolation and identification technique.[4]"

      So NTM is the true direction for Arikace. It is virtually a efficacious treatment vacuum right now, but do not overlook the South Koreans and their clinical trial of inhalation amikacin solution.

      CF/Pa is an orphan treatment regimen that has an evolving cadre of antibiotic competition. This will be a numerical market entry. Not exponential. It will not be the basis of INSM moving up more than $20 per share in the forseeable future. That is with FDA and EMEA approvals.

      • 1 Reply to insm_truth_teller
      • by rehdvm2004.Nov 20, 2012 10:42 AM.Permalink
        .

        Several points associated with a parallel post.

        The risk of finding precancerous lesions in the dog study is low. Not only because dogs are carnivores and metabolize fatty substances better than rats, but their lung field is about the biggest of any mammal that could be used for the study. Remember the dosing is based upon body weight, not lung size. Therefore a 560mg treatment dose gets more widely distributed in the lungs and is easier to clear. Also, the original dog study performed (probably) did not show the "foamy macrophages" because they did not look for such a lesion. The usual stains for tissue samples are Hemotoxylin and Eosin, but this time they are going use Sudan stains for fat deposits. This will allow a final determination concerning fat accumulation and carcinogenicity. But the bottom line is that this dog study will expedite filing the NDA for some type of use.

        As for Slam Dunk, this term must be excluded from being associated with any INSM clinical trial. This company has managed to mis-direct, under-perform and screw-up many opportunities with unique products.

        Iplex is now a an out-licensed, royalty only part of the INSM future. If you want to re-invest in Premiplex, wait for Premacure to go public. They will sell the stock to former INSM investors. Also watch for Hellstrom and Smith to publish more about these premies and their actual lung development and absence of ROP. The key here is that a premie of around 1000 grams gets to the PICU discharge weight of around 3.5 pounds in a period of time less than 60 days. That will be an endpoint that is undeniable. If these premies never develop ROP in two years of follow-up, that will be the a Slam Dunk for Premacure.

        Forget PCUT. That will never result in anything other than low cost treatment for ALS. But that model will never mean any more than a royalty for INSM. The PCUT original model of 2009 had INSM getting up to 39-43% royalty. But that is when INSM and BR were saying PCUT had "no skin in the game." Now INSM has only the skin from one finger in the game. You can figure out for yourselves which finger it is.

        So NTM is the biggest Arikace option. This is not an orphan drug indication, per se because the number of different strains of mycobacteria that are causing this infection are increasing as the methods of diagnosis improve. The following quote is on the wiki site for NTM:

        "The number of identified and cataloged NTM species has been increasing rapidly, from about 50 in 1997 to over 125 by January 2007. The surge is mainly due to improved isolation and identification technique.[4]"

        So NTM is the true direction for Arikace. It is virtually a efficacious treatment vacuum right now, but do not overlook the South Koreans and their clinical trial of inhalation amikacin solution.

        CF/Pa is an orphan treatment regimen that has an evolving cadre of antibiotic competition. This will be a numerical market entry. Not exponential. It will not be the basis of INSM moving up more than $20 per share in the forseeable future. That is with FDA and EMEA approvals.

    • MF prefaced common investor sense with a background check :Insmed has been a consistant loser.
      then a dose of reality:
      " last year over safety concerns in tested animals reminded investors just how fragile and uncertain Arikace's chances of approval still are."
      Slam dunk seems to be a running joke on this board

      another offering is very possible
      The stock has just made a big run
      pigs get killed

    • Hint:

      "Arikace™-Liposomal Amikacin: Preclinical Summary - Insmed
      Adobe PDF
      – Toxicology in dogs and rats ... clinical studies. Arikace™ liposome ... Aqueous interior. encapsulated. amikacin. Arikace™-Liposomal Amikacin: Preclinical Summary. Arikace TM . . ."

      Well I cannot complain that much. I missed the two boys in the Premiplex dose ranging/pharmacokinetic abstract reported by Dr. M. Ley. But fortunately Clown 3 sh e-mailed me to tell me my eyesight was faulty. I fixed that by having cateract surgery. Now if I could just ge rid of this ADHD!?!.

      Like I said, those that live by a double standard will perish by the same criteria.

      Also, since Clown 2 cannot figure out where NTM is coming from he should consider doing a Medline search.

      Using keywords "in vitro versus in vivo AND antibiotic sensitivity" by the required Boolen input required system, 109 citations come up including this one that deals specifically with NTM:

      "Enferm Infecc Microbiol Clin. 2011 Dec;29 Suppl 5:66-75.
      [Atypical mycobacteria and pulmonary involvement in infectious diseases].
      [Article in Spanish]
      Camarena Miñana JJ, Pellicer RG.
      SourceServicio de Microbiología, Hospital Universitario Dr. Peset, Valencia, España. juan.camarena@uv.es

      Abstract
      Nontuberculous mycobacteria (NTM) are increasingly associated with infectious pulmonary disease. NTM are ubiquitous environmental pathogens with high isolation rates worldwide. The greater frequency of NTM associated with pulmonary diseases is probably due to a combination of increased exposure, improved diagnostic methods and an increase in the prevalence of risk factors predisposing individuals to infection. Difficulty may arise in determining whether an isolate from a respiratory sample is in fact a contaminant or a pathogenic organism. The ATS/IDSA guidelines highlight the importance of following microbiological and clinical criteria in making a diagnosis of NTM lung infection. These criteria may not be useful for all NTM and species-level identification is strongly recommended. Mycobacteria identification by conventional methods has been the standard in most clinical microbiology laboratories. However, conventional testing alone does not allow identification of many NTM. Newer, rapid molecular methods such as commercially available nucleic acid probes, genomic amplification and DNA sequence analysis should be used. Communication between the clinician and the laboratorian is essential to decide whether an isolate could be sent to a reference laboratory to determine the best method for species identification. Although the CLSI has recently published an approved standard for NTM susceptibility testing, there is ongoing debate about the role of in vitro susceptibility for managing patients with NTM disease. The goal of this review is to describe the mycobacteria involved in lung disease, the factors that predispose to this infection, its diagnosis with alternative procedures and the correlation between in vitro and in vivo treatment response."

      The important points in this abstract are the determination that an NTM isolate is a contaminant (breathed in but not infecting the lungs) or an infective organism (one that is living off the host). The last sentence of the abstract is particularly important to figuring out how to treat a patient and what antibiotic to use. In vitro (culture plate) sensitivity does not necessarily correlate with in vivo (treatment of the patient) activity. This is the case with every antibiotic known.

      But to answer the huge question concerning Clown 2, NTM comes from "digging in your garden" or drinking or inhaling "contaminated water." NTM comes from the environment. There is no mystery, just common sense. No one who is immune suppressed (by steroids or by failure of their immune system should be gardening, excavating, making sand castles at the beach, drinking anything other than bottled fluids that have been pasturized or sterile filtered, etc. To do otherwise is folly. I know because of my foster daughter from Kentucky. The second she stopped drinking tap water, her ear infections and bouts with pneumonia stopped.

      Only two physicians have ever commented on Arikace on this MB and the text messaging Spumpers drove them for cover. Too bad. The art of medicine (diagnosis, prescriptive treatment and monitoring treatment for efficacy) is the essence of using antibiotics properly in humans or animals. That simple.

      Sentiment: Hold

      • 2 Replies to rehdvm2004
      • But there is a total lack of understanding human medicine.

        Immune suppressants (steroids) are necessary right now because COPD patients are predisposed to pulmonary inflammatory reactions from thousands of different airborne contaminants (not just NTM). Dust, dander, pollen and other foreign materials. You name it. If it causes irritation of the respiratory tract, it can cause a COPD patient to have an attack. But the correlation with NTM is simple. No COPD patient should go outdoors into a risky area of the environment without taking their meds and (probably) wearing a surgical mask. Masks that are equivalent to surgical masks are available in any hardware store. They are sold to protect people who use spray and oil based paints. Anyway, no COPD patient should unwittingly get exposed to NTM. Or 100 other bacteria for that matter. That is the medical point.

        As for the poor search technique by Clown 2, I did not use the key word "toxicology" because that term is mostly obsolete. I used the trems "preclinical safety study" along with the terms "dog" and "Arikace." That is how the citation was elicited. The citation quoted is what appeared on the INSM website. But do not expect a stock broker/Spumper/Clown to understand that subtle difference.

        So the stock continues to inch up (now $0.80 per share on the pre-RS basis) and Longs can wait a bit longer and see if the critical information that will bump the SP to $11 will occur before or after the New Year. I personally am awaiting the first NTM efficacy report. That will be the bell ringer. If the NIH collaboration reports eradication in a significant number of treated patients within 30 days, the stock will really go up. Even if they only get two logs reduction, that will be clinically significant. But Longs will have to wait and see.

        Sentiment: Hold

      • Rumdum - That was a long, long boring post.

        Just a few quick comments. First, thanks for confirming that over prescribing corticosteroids is a contributing factor to the growing NTM problem.

        Second, I was searching carcinogenicity, not toxicology for an additional dog study.

        Third, and most important.....You learned how to get to a company website???

        The higher the stock goes the longer your posts get.....thanks for keeping all of us non-doctors so informed.

    • Risk Assessment versus Slam Dunk
      By rehdvm2004.Nov 20, 2012
      Several points associated with a parallel post.

      The risk of finding precancerous lesions in the dog study is low. Not only because dogs are carnivores and metabolize fatty substances better than rats, but their lung field is about the biggest of any mammal that could be used for the study. Remember the dosing is based upon body weight, not lung size. Therefore a 560mg treatment dose gets more widely distributed in the lungs and is easier to clear. Also, the original dog study performed (probably) did not show the "foamy macrophages" because they did not look for such a lesion. The usual stains for tissue samples are Hemotoxylin and Eosin, but this time they are going use Sudan stains for fat deposits. This will allow a final determination concerning fat accumulation and carcinogenicity. But the bottom line is that this dog study will expedite filing the NDA for some type of use.

      As for Slam Dunk, this term must be excluded from being associated with any INSM clinical trial. This company has managed to mis-direct, under-perform and screw-up many opportunities with unique products.

      Iplex is now a an out-licensed, royalty only part of the INSM future. If you want to re-invest in Premiplex, wait for Premacure to go public. They will sell the stock to former INSM investors. Also watch for Hellstrom and Smith to publish more about these premies and their actual lung development and absence of ROP. The key here is that a premie of around 1000 grams gets to the PICU discharge weight of around 3.5 pounds in a period of time less than 60 days. That will be an endpoint that is undeniable. If these premies never develop ROP in two years of follow-up, that will be the a Slam Dunk for Premacure.

      Forget PCUT. That will never result in anything other than low cost treatment for ALS. But that model will never mean any more than a royalty for INSM. The PCUT original model of 2009 had INSM getting up to 39-43% royalty. But that is when INSM and BR were saying PCUT had "no skin in the game." Now INSM has only the skin from one finger in the game. You can figure out for yourselves which finger it is.

      So NTM is the biggest Arikace option. This is not an orphan drug indication, per se because the number of different strains of mycobacteria that are causing this infection are increasing as the methods of diagnosis improve. The following quote is on the wiki site for NTM:

      "The number of identified and cataloged NTM species has been increasing rapidly, from about 50 in 1997 to over 125 by January 2007. The surge is mainly due to improved isolation and identification technique.[4]"

      So NTM is the true direction for Arikace. It is virtually a efficacious treatment vacuum right now, but do not overlook the South Koreans and their clinical trial of inhalation amikacin solution.

      CF/Pa is an orphan treatment regimen that has an evolving cadre of antibiotic competition. This will be a numerical market entry. Not exponential. It will not be the basis of INSM moving up more than $20 per share in the forseeable future. That is with FDA and EMEA approvals.

      Sentiment: Hold

      • 1 Reply to insm_truth_teller
      • By satltsasw.Nov 20, 2012 1:07 PM.

        1. Zero sales...the regulatory path between here and commercial sales is longer than a year. No regulatory approval, no sales.
        2. Large mfring facility...regardless of "access" Insmed must still qualify the manufacturing of a new product line. This would involved a fully staffed QA/QC operation at both Insmed and the manufacturing facility that would address the manufacturing of Arikace. Not a previously manufactured drug.
        3. Zero sales force. No drug, no sales force. No competent company hires in advance of readiness to actually sell the drug. Further, the sales staff must have complete printed materials on the drug with attendant disclaimers etc. The legal time to codge that together is months. Graphic design, packaging etc takes several weeks to complete. And that cannot be completed until the legal language and IFUs are completed.
        4. Zero infrastructure. The infrastructure needed to run a company in the steps from R&D to startup to pilot manufacturing to large scale manufacturing, with attendant QA and regulatory is enormous. I'm not sure what your background is, but you do not understand infrastructure. Engineering, sales, chemistry, R&D, regulatory, inside/outside sales, marketing, legal, IT, production, packaging, never ending inside and outside audits, procurement and logistics, real estate and space management, contracts and legal, finance.
        5. Yes...I venture to say that Insmed will have zero of these.

        And, the pre-emptive name calling of "windbag" .... your response is complete.

    • rummdumm - what in the world are you talking about:

      Also, the original dog study performed (probably) did not show the "foamy macrophages" because they did not look for such a lesion.

      The original dog study?????

      Good to see you quoting from wikipedia again though - I feel certain that is exactly what the scientists at Insmed use.....

      I do see that you now have a cult following on this MB..... lots of thumbs up. Terry, and Terry, and Terry, and.....

 
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