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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Sep 12, 2012 12:12 PM Flag

    FaceTheFacts INSM Longs

    Witless leaving (being fired?) is not a surprise to many longs. In March 2011 INSM he had four Phase III studies agreed upon with the FDA, but had not revealed and/or considered the significance of the finding that two rats in the carcinogenicity study had foamy macrophages in the lungs. This would be considered a precancerous lesion for any other type of study EXCEPT one where all the rats were breathing in a liposome for two years. In this latter instance a finding in two rats would be worthy of closer examination using the specific mutation mouse models of carcinogenic potential. Not a multimillion dollar dog study.

    But there are other members of INSM uppermanagement who are sitting on the bubble. There top level management of this company has too many technical advisors, pseudo-regulatory types and carry-over personnel from the MS and Transave era. The only ones who are not, in my view in a sensitive position are Gupta (the company needs a Chief Medical Officer to sponsor Phase III clinical trials and Drucker. There are a lot of legal issues before INSM in cleaning up past mistakes. But the one change that is evident on the INSM website that convinces me there are others to go is the Careers menu. They are still looking for a Senior VP of Regulatory. That means that all the other pseudo-regulatory types are in labile positions. And I do not think that Will Lewis is going to be hesitant about cutting slackers loose. Anyway we shall see.

    Sentiment: Hold

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    • Setting aside the "idiot finge" name callers who have a 100% track record of being wrong on issues associated with INSM mismanagement, Lewis has enacted what I suggested more than a year ago about the the performances of Whitless, LaBella and others. Totally "underwhelming."

      But the Fact is that the pending results for treating NTM is where the future lies for INSM. That is a "treatment vacuum" where no current therapy is effective. If someone interested in this subject read the description of the clinical trial, one would understand that the ONLY criteria for exclusion are:

      1.Forced Expiratory Volume in 1 second (FEV1) 450 msec for males or QTc 470 msec for females. High cardiac risk.
      3.Subjects with hemoptysis of ≥60 mL in a 24 hour period within 4 weeks prior to screening. Blood in sputum indicating blood in lungs.
      4.Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within one year prior to screening or anticipated during the study period. Active primary or secondary cancer.
      5.Active allergic bronchopulmonary mycosis or any other condition requiring systemic steroids at a dose ≥ equivalent of 10 mg/day of prednisone within 3 months prior to screening or anticipated during the study period. A fungal infection of the lungs.
      6.Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening. History of TB which can be masked by NTM.
      7.History of lung transplantation. Lung transplants require antirejection (immune suppression) and/or steroids (refer to 5 above).
      8.Hypersensitivity to aminoglycosides. Allergy from previous treatment with amikacin, tobramycin or other aminoglycoside.
      9.Any change in chronic NTM multi-drug regimen within 28 days prior to Study Day 1. Results of recent change cannot be clinically assessed accurately.
      10.Evidence of biliary cirrhosis with portal hypertension. Cirrhotic liver, decreased liver metabolism and resultent high blood pressure
      11.History of daily, continuous oxygen supplementation. Relates to damage and scarring in 1 above.
      12.Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study. Obvious precursor to clinical trial failure.

      What is NOT excluded is CF patients with NTM. HIV patients with NTM. Or other concurrent disease patients with NTM. That is because the FDA accepts that hypothesis and whatever data is available So this clinical trial has the most potential to progress to market quickly. All the study has to show is the Arikace reduces NTM in sputum like no other inhalational or systemically administered antibiotic and/or or that sometime during those 84 days of treatment, NTM disappears. This goes right to the heart of a life saving therapy that the FDA will expedite to approval. This study is the future of Arikace and INSM right now. Not much else. Particularly in view of the fact that the other 61 clinical trial sites for CF/Pa have still not been added to the Clear-108 clinical trial information at ClinicalTrialDOTgov (per the Whitless CC last).

      PS - I missed the two boys in the more recent FTF INSM Longs, but the salient point in my post was "continuous IV infusion" with safety for periods up to 7 days in premies 900 to 1200 grams in weight was the important focal point of the abstract. Thank you Dr. Ley, et al. I hope that Premacure does an IPO in the next 5 years. That science, medical approach and offering would be invaluable ten years from now. As for Iplex, anyone can go to fdaDOTgov and search out that Iplex is a "discontinued drug" which means there is no FDA approved site making the drug. So much for Merck "secretely making batches" since 2009. LOL!

      Sentiment: Hold

      • 5 Replies to rehdvm2004
      • Setting aside the "idiot finge" name callers who have a 100% track record of being wrong on issues associated with INSM mismanagement, Lewis has enacted what I suggested more than a year ago about the the performances of Whitless, LaBella and others. Totally "underwhelming."

        But the Fact is that the pending results for treating NTM is where the future lies for INSM. That is a "treatment vacuum" where no current therapy is effective. If someone interested in this subject read the description of the clinical trial, one would understand that the ONLY criteria for exclusion are:

        1.Forced Expiratory Volume in 1 second (FEV1) 450 msec for males or QTc 470 msec for females. High cardiac risk.
        3.Subjects with hemoptysis of ≥60 mL in a 24 hour period within 4 weeks prior to screening. Blood in sputum indicating blood in lungs.
        4.Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within one year prior to screening or anticipated during the study period. Active primary or secondary cancer.
        5.Active allergic bronchopulmonary mycosis or any other condition requiring systemic steroids at a dose ≥ equivalent of 10 mg/day of prednisone within 3 months prior to screening or anticipated during the study period. A fungal infection of the lungs.
        6.Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening. History of TB which can be masked by NTM.
        7.History of lung transplantation. Lung transplants require antirejection (immune suppression) and/or steroids (refer to 5 above).
        8.Hypersensitivity to aminoglycosides. Allergy from previous treatment with amikacin, tobramycin or other aminoglycoside.
        9.Any change in chronic NTM multi-drug regimen within 28 days prior to Study Day 1. Results of recent change cannot be clinically assessed accurately.
        10.Evidence of biliary cirrhosis with portal hypertension. Cirrhotic liver, decreased liver metabolism and resultent high blood pressure
        11.History of daily, continuous oxygen supplementation. Relates to damage and scarring in 1 above.
        12.Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study. Obvious precursor to clinical trial failure.

        What is NOT excluded is CF patients with NTM. HIV patients with NTM. Or other concurrent disease patients with NTM. That is because the FDA accepts that hypothesis and whatever data is available So this clinical trial has the most potential to progress to market quickly. All the study has to show is the Arikace reduces NTM in sputum like no other inhalational or systemically administered antibiotic and/or or that sometime during those 84 days of treatment, NTM disappears. This goes right to the heart of a life saving therapy that the FDA will expedite to approval. This study is the future of Arikace and INSM right now. Not much else. Particularly in view of the fact that the other 61 clinical trial sites for CF/Pa have still not been added to the Clear-108 clinical trial information at ClinicalTrialDOTgov (per the Whitless CC last).

        PS - I missed the two boys in the more recent FTF INSM Longs, but the salient point in my post was "continuous IV infusion" with safety for periods up to 7 days in premies 900 to 1200 grams in weight was the important focal point of the abstract. Thank you Dr. Ley, et al. I hope that Premacure does an IPO in the next 5 years. That science, medical approach and offering would be invaluable ten years from now. As for Iplex, anyone can go to fdaDOTgov and search out that Iplex is a "discontinued drug" which means there is no FDA approved site making the drug. So much for Merck "secretely making batches" since 2009. LOL!

      • it's funny This bio has 9 months or more. iPlex is secretely being produced so we see a $100 dollar stock ! #$%$!The trial is the story here

      • Thanks.
        A good post among a sea of Washwomen blabbing about someone.

      • Welcome back, Rehd. I was hoping all was well with you with the storm out east. Question.....what is number 2 in your list. It appears to be missing.

        Thanks

      • "What is NOT excluded is CF patients with NTM."

        An understandable mistake for a layman such as yourself who is unfamiliar with the clinical trial process. A study such as that would, of course, exclude volunteers with other serious lung conditions such as Cystic Fibrosis and Tuberculosis.

        And as regards your rather naive belief that NTM is the future for Insmed, try to look at this study not as the proof that Aikace can eliminate NTM infection, but that it can eliminate multi-drug-resistant mycobacterial infection.

        Think MDR-TB. Renu gave you the hint in the presentation she made earlier this year :-)

    • I also don't think he will be slow to sell Insmed to a major pharma sometime before June 2013.

      Sentiment: Buy

    • Has insmed seen the first CF results? Management is trying to dump this company and guess who will be holding the bag?!

    • FaceTheFacts INSM Longs
      By rehdvm2004 . 4 days ago . Permalink
      Witless leaving (being fired?) is not a surprise to many longs. In March 2011 INSM he had four Phase III studies agreed upon with the FDA, but had not revealed and/or considered the significance of the finding that two rats in the carcinogenicity study had foamy macrophages in the lungs. This would be considered a precancerous lesion for any other type of study EXCEPT one where all the rats were breathing in a liposome for two years. In this latter instance a finding in two rats would be worthy of closer examination using the specific mutation mouse models of carcinogenic potential. Not a multimillion dollar dog study.

      But there are other members of INSM uppermanagement who are sitting on the bubble. There top level management of this company has too many technical advisors, pseudo-regulatory types and carry-over personnel from the MS and Transave era. The only ones who are not, in my view in a sensitive position are Gupta (the company needs a Chief Medical Officer to sponsor Phase III clinical trials and Drucker. There are a lot of legal issues before INSM in cleaning up past mistakes. But the one change that is evident on the INSM website that convinces me there are others to go is the Careers menu. They are still looking for a Senior VP of Regulatory. That means that all the other pseudo-regulatory types are in labile positions. And I do not think that Will Lewis is going to be hesitant about cutting slackers loose. Anyway we shall see.

    • By rehdvm2004 . 4 days ago . Permalink
      Witless leaving (being fired?) is not a surprise to many longs. In March 2011 INSM he had four Phase III studies agreed upon with the FDA, but had not revealed and/or considered the significance of the finding that two rats in the carcinogenicity study had foamy macrophages in the lungs. This would be considered a precancerous lesion for any other type of study EXCEPT one where all the rats were breathing in a liposome for two years. In this latter instance a finding in two rats would be worthy of closer examination using the specific mutation mouse models of carcinogenic potential. Not a multimillion dollar dog study.

      But there are other members of INSM uppermanagement who are sitting on the bubble. There top level management of this company has too many technical advisors, pseudo-regulatory types and carry-over personnel from the MS and Transave era. The only ones who are not, in my view in a sensitive position are Gupta (the company needs a Chief Medical Officer to sponsor Phase III clinical trials and Drucker. There are a lot of legal issues before INSM in cleaning up past mistakes. But the one change that is evident on the INSM website that convinces me there are others to go is the Careers menu. They are still looking for a Senior VP of Regulatory. That means that all the other pseudo-regulatory types are in labile positions. And I do not think that Will Lewis is going to be hesitant about cutting slackers loose. Anyway we shall see.

      • 2 Replies to insm_truth_teller
      • By rehdvm2004 . 4 days ago . Permalink
        Witless leaving (being fired?) is not a surprise to many longs. In March 2011 INSM he had four Phase III studies agreed upon with the FDA, but had not revealed and/or considered the significance of the finding that two rats in the carcinogenicity study had foamy macrophages in the lungs. This would be considered a precancerous lesion for any other type of study EXCEPT one where all the rats were breathing in a liposome for two years. In this latter instance a finding in two rats would be worthy of closer examination using the specific mutation mouse models of carcinogenic potential. Not a multimillion dollar dog study.

        But there are other members of INSM uppermanagement who are sitting on the bubble. There top level management of this company has too many technical advisors, pseudo-regulatory types and carry-over personnel from the MS and Transave era. The only ones who are not, in my view in a sensitive position are Gupta (the company needs a Chief Medical Officer to sponsor Phase III clinical trials and Drucker. There are a lot of legal issues before INSM in cleaning up past mistakes. But the one change that is evident on the INSM website that convinces me there are others to go is the Careers menu. They are still looking for a Senior VP of Regulatory. That means that all the other pseudo-regulatory types are in labile positions. And I do not think that Will Lewis is going to be hesitant about cutting slackers loose. Anyway we shall see.

      • FaceTheFacts INSM Longs
        By insm_truth_teller . 16 hours ago . Permalink Go to topic
        By rehdvm2004 . 4 days ago . Permalink
        Witless leaving (being fired?) is not a surprise to many longs. In March 2011 INSM he had four Phase III studies agreed upon with the FDA, but had not revealed and/or considered the significance of the finding that two rats in the carcinogenicity study had foamy macrophages in the lungs. This would be considered a precancerous lesion for any other type of study EXCEPT one where all the rats were breathing in a liposome for two years. In this latter instance a finding in two rats would be worthy of closer examination using the specific mutation mouse models of carcinogenic potential. Not a multimillion dollar dog study.

        But there are other members of INSM uppermanagement who are sitting on the bubble. There top level management of this company has too many technical advisors, pseudo-regulatory types and carry-over personnel from the MS and Transave era. The only ones who are not, in my view in a sensitive position are Gupta (the company needs a Chief Medical Officer to sponsor Phase III clinical trials and Drucker. There are a lot of legal issues before INSM in cleaning up past mistakes. But the one change that is evident on the INSM website that convinces me there are others to go is the Careers menu. They are still looking for a Senior VP of Regulatory. That means that all the other pseudo-regulatory types are in labile positions. And I do not think that Will Lewis is going to be hesitant about cutting slackers loose. Anyway we shall see.

    • ^NBI continues to make 2012 one of the best years in bios ever.
      A few very nice looking charts.
      INSM with no volume or interest remains a news driven stock.
      The downtrend is intact from last year.

      ===========
      A couple of these MBs are focusing on the coming fiscal cliff which I think may effect INSM far more than losing the 2 most important people running the company ( whew! )

      The Federal Reserve announced “QE-infinity.” the Fed will print $40 billion per month — $480 billion per year ...
      imho It's the other shoe ( to drop) of the morgage backed securities fraud and the governement continues to print funny money to banks.

      The other shoe WILL drop.Jan1 ? perhaps but when it does it will be violent
      Raise cash and be happy

      Good Luck

    • Once again rumdum, if they only had you they could have saved a couple of million dollars. My question is how do you know that INSM didn't do exactly whatever the heck it is that you just said. (mutation mouse models of carcinogenic potential - you aren't trying to sound intelligent are you?) The FDA demanded the dog study AFTER Insmed presented their evidence that cancer should not be a concern. You act like someone at Insmed said "Hey, we can just go and do a dog study!" You continue to be the strangest stockholder I have seen.

    • One issue that should be open for discussion, is, if Whitten where truly FIRED, why pay him such
      a large, and out of place severance? The company, in essence, paid him handsomely to leave.??
      I think the company line is he didn't have the chops to get this across the finish line, and had
      probably bungled, as Redv says, a couple of pretty simple actions. I think mangement (the BOD)
      couldn't take another chance that he would make a mistake, especially since he was pretty much
      learning on the job, and went out into the market, and hooked a player up. (that's ebonics for "they
      found a ringer")

 
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