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Insmed Incorporated Message Board

rehdvm2004 344 posts  |  Last Activity: 32 minutes ago Member since: Oct 21, 2004
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  • just blew away all the daytraders, MMs and bashers! EOS for the low lifes!

    Sentiment: Strong Buy

  • Reply to

    Bubonic Plague Surfaces in China

    by sprinterman1 1 hour 50 minutes ago
    rehdvm2004 rehdvm2004 38 minutes ago Flag

    Bubonic Plague is a bacterial disease (Yersenia pestis) that is transmitted to humans who dig in soil where rodents are burrowed in the ground. The bacteria contaminates their urine and rodents mark their burrows by urinating around the entrance (so they do not try to hid somewhere they are not welcome). The bacteria survive in the soil for varying lengths of time. So when a farmer type person comes along and wants to plant something near this burrow, digs in the soil and inhales the bacteria . . . bingo . . . Bubonic Plague. Same for Hanta virus, Leptospirosis and other infectious agents associated with rodent urine. Anthrax also occurs naturally in the US!?!

    Inovio is not going to chase every infectious agent with their vaccine technology. If they accomplish what they are onto already, there will be millions of lives that are protected and saved.

    GLTAL

    Sentiment: Strong Buy

  • The EIS is very complete and well presented. Hopefully Shore will be mining actively before the winter sets in. The signal for the onset of operations will be the announcement of pit mining jobs on the Shore Gold website and/or in Saskatchewan, CD.

    GLTAL

    Sentiment: Buy

  • Reply to

    US Could be faceing a Health Crise!

    by parabalic55 Jul 18, 2014 9:37 PM
    rehdvm2004 rehdvm2004 Jul 19, 2014 12:14 PM Flag

    The most pathogenic form of TB, MDR TB (Multidrug Resistant TB) is all over the world. Not just in the Western Hemisphere south of the US border. Actually, the hottest spots are in the Caribbean in the Western Hemisphere. You should go to the CDC website and read up on the potential health hazards associated with TB. Besides TB can be tested in 48-72 hours with a Tine (skin test). The more serious problem from Central America would be the Dengue Fever (hemorrhagic) viruses that have crossed the Pacific from Asia. The CDC and NIH has been working on vaccines for those viruses for years.

    Concerning the epidemiology of infectious viral diseases, the US/NIH/CDC will work hard on the ones that are approaching the US border through Mexico first then the ones that might trickle in from the random or odd incidental infection from Asia, Africa or the Middle East second. That is just pragmatic good medical planning. Some of the others will be worked upon if they represent bioterrorist agents. But that is why we have the NEIDL in Boston and other locations.

    If you are worried, look at the new drugs that NIH and others are working on for MDR TB. Go to ClinicalTrialsDOTgov, which you should be doing anyway to monitor Inovio progress.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Jul 18, 2014 11:57 AM Flag

    What is the reference for this statement? You should include that because it would kill the shorts and bashers immediately. Everyone wants these bozos to disappear and that would be that!

    Sentiment: Strong Buy

  • Reply to

    Test Results and Stock Price - Survey

    by radwastecollector Jul 18, 2014 11:03 AM
    rehdvm2004 rehdvm2004 Jul 18, 2014 11:48 AM Flag

    Your projections look pretty good, but you need to keep several requirements in mind:

    1. Inovio must submit the data to the FDA in support of the Phase IIb Clinical Trial first and let the FDA judge the results. It is a regulatory requirement under CFR (Code of Federal Regulations) 310. If the Feds judge the data is good enough for a Phase III, or (better yet) that they accept the data from the Phase IIb as final data, Inovio jumps when the news is subsequently made public.

    2. The theoretical statistical threshold for meeting the milestone for a clinical outcome is 70% of the patients benefit from vaccination. Why? Because 70% positive response (antibody and decrease of cervical and metastatic HPV induced lesions) is two standard deviations of 10% removed from a plus or minus 50%. Fifty percent is viewed as a chance outcome with no clear clinical benefit and would require (essentially starting over) by increasing the dose, or other clinical trial modification.

    So I am looking at your 72% projection and believe that is a critical threshold. I am also hoping that the response is 90% favorable because the FDA will (probably . . . hopefully) give expedited status to the vaccine development project and Inovio (plus partner) will be applying for a BLA (Biologics License Application) in 2015. That would hit my projected target investment pretty close. I invested in March of 2013 and March 2016 is the goal for this investment maturing.

    Sentiment: Strong Buy

  • Reply to

    e-mail to Dr. Dowell - CDC

    by markbuti Jul 17, 2014 10:46 PM
    rehdvm2004 rehdvm2004 Jul 18, 2014 11:13 AM Flag

    You need to read about Ebola first. "Ebola wiki" is a good starting point. Ebola as a bioweapon is a real threat, but it is not a naturally occurring emerging health care threat. There have been three outbreaks outside Africa (UK and Russia twice). They were laboratory accidents involving single individuals. All the major outbreaks occurred in Africa. That is not implying that Africans are not worthy of protection, but the fact remains that Ebola (which was originally thought to be a variant of Marburg Virus usually occurs from exposure to Simian Hemorrhagic Fever Virus by direct consumption of uncooked or under cooked monkey meat. The 1996 epidemiological study of the "charcoal worker who found the monkey carcass on the way home and cooked it up for his family" clearly characterizes the problem. But Africa is protein starved and many people eat road kill. Look at the famous monkey outbreak in the US at the Reston Research Laboratory in VA. The virus never got to humans because it had not "amplified" (adapted from monkeys to humans). The caretakers for the monkeys (while the animals were dying) were wearing overalls and paper masks. Not much protection from a Level 4 infectious virus. As Dr. Jerry Jax said in his presentation at AALAS, "I walked into the animal facility in my space suit and the guy cleaning up and feeding the animals was in overalls with a paper mask. We looked at each other and both recognized at once that one of us was nuts!"

    Besides, CDC collaborates in performing vaccine studies, but approval goes through the FDA.

    Inovio needs to concentrate on the Herpes viruses already under investigation and malaria. Those will beneficially protect and help millions of existing patients.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Jul 17, 2014 8:48 AM Flag

    If you referring to a clinical trial and a asking how can this be? The answer is the proprietary science and medicine controls the clinical trial. Even if Novartis came up with and patented the original antigenic molecule, the fact that it was put into a circular configuration that was delivered by electorporesis makes is a unique patent to Inovio and gives them a commanding royalty. Inovio has no direct marketing capability. That is where Novartis comes into the picture.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    possible data release after market closed....

    by mr_dbsbsm Jul 16, 2014 12:57 PM
    rehdvm2004 rehdvm2004 Jul 16, 2014 1:17 PM Flag

    That would mean the data was unblinded shared with the FDA, which in turn agreed that the data either supported a Phase III or indicated that data was good enough for INO to submit a BLA for approval. Public, stock holder announcements occur after the regulatory officials have voted thumbs up or thumbs down. INO is still a strong buy, but the pathway for licensing and approval is torturous and protracted. I am into the second year of holding this stock based upon DD which indicated they would get a product in 2015. Lets see who knows about this company. Scientists or day traders.

    GLTAL

    Sentiment: Strong Buy

  • Unblinded data has to be submitted to the FDA/EMEA first before it is release for public consumption or stock holder information. That is the requirement for conducting a FDA approved clinical trial. They (the Feds) have the first-right-of-refusal for any interpretation of the data in terms of safety and efficacy. Anything to do with public perception of the safety and efficacy is inconsequential to the regulatory agencies.

    GLTAL

    Sentiment: Strong Buy

  • There are at least three major accomplishments (milestones) that have been accomplished by ARDM:

    1. In order to initiate the Phase III, the formulation has been finalized and they have demonstrated that they can reproducibly manufacture batches within a specified a "formulation." These formulations have narrow limits of composition that "must be met on a batch by batch basis" and be released by the FDA. Those limits include the amounts of Cipro per amount of lipid carrier. Enough said. If you look at the package insert for any drug, it describes the formulation within narrow limits.

    2. They have a fixed relationship with the producer of the inhalation device. The clinical study cannot be performed with just any inhalation device. They are linked forever into the future unless ARDM does another study with another podhaler that shows equivalent delivery.

    3. The case load seems considerable (255) until the case load is juxtaposed against the number of institutions participating (80). Based upon the simple mathematical equation, each institution only needs to enroll 3 people to get within range of the total enrollment number.

    While bronchiectasis patients are "rare" they do have problems responding to the existing inhalational antibiotics. The Cystic Fibrosis Foundation is tracking about 10 approved and developing inhalational antibiotics for various pulmonary conditions.

    Now for the good news. Bayer 3939 appears to be paving the way. It is an inhalational solution of Cipro which must be inhaled twice daily. ARDM's Pulmaquin only requires a once per day treatment.

    We shall see.

    GLTAL

  • Reply to

    Afrezza approved!

    by cakeyt Jun 27, 2014 4:50 PM
    rehdvm2004 rehdvm2004 Jun 29, 2014 11:51 AM Flag

    The regulatory pathway for "inhalational antibiotics" is very well represented of the Cystic Fibrosis Foundation website and by following the regulatory progress of companies that make these inhalational antibiotics (Novartis, Bayer, Insmed, Galead, etc.). Inhalational antibiotics are the key in treating Cystic Fibrosis. INSM recently got "breakthrough drug" status from the FDA for treating non-tuberculosis mycobacterium (NTM).

    The only direct competition with ARDM is Bayer in Europe. Both have a Ciprofloxacin inhalational antibiotic under study. Both have Phase III studies. But there are important differences. The ARDM product is in a liposome which is taken up by the fixed macrophages in the lungs which, importantly, is the cell type that collects the infective bacteria. Liposomes also penetrate the "biofilm" which is a mucous barrier that can protect bacteria from being eradicated by antibiotic solutions alone. This also presents that final benefit of Pulmoquin (once per day inhalation therapy versus twice per day for Bayer's Cipro solution). Stay tuned. With the backing for Pulmoquin going forward, they should be in good condition in 2-3 years.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    I live not far from Blue Bell

    by perl_is_great Jun 18, 2014 10:35 AM
    rehdvm2004 rehdvm2004 Jun 18, 2014 11:04 AM Flag

    If you talk with Dr. Kim, there are a few questions that might clarify important points for Longs:

    1. Does Inovio perform all the regulatory filings, or is it a joint effort between collaborating institutions? Academic institutions like U Penn (in general) do not have experienced regulatory groups who file with FDA or other regulatory agencies under ICH. Accordingly, Inovio would be filing the clinical trial protocols and the BLAs (Biologics Licensing Agreements).

    2. Does Inovio pay a royalty to the institutions for the novel antigens or molecules that lead to creation of the patented plasmids? The process of isolating a factor that is a cell surface antigen or nuclear antigen for these infective agents or cancer surface antigens has to be a very broad based basic science effort. If an institution comes to Inovio with one of these agents that is 99% involved with an infective or cancer condition, there must be some "finders fee." Institutions are not just giving these molecules to Inovio for nothing.

    3. Does Inovio have an outreach program besides the wide symposium, conference, publication effort? Are they (Inovio scientists) scanning the biomolecule literature for newly isolated factors for infectious diseases and/or cancer? Or do they get enough inquiries to sustain an exponentially expanding research and development base?

    4. How many of the current collaborations have led to other potential projects? U Penn now has a license to (presumably) use Inovio technology in house (at U Penn). Does Inovio see this type of collaboration as a major effort in the future?

    Hope Dr. K has time to talk with you. As an alumni or former staffer at U Penn, you probably have some visibility.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Scientifically it made no sense . . .

    by rehdvm2004 Jun 11, 2014 10:22 AM
    rehdvm2004 rehdvm2004 Jun 11, 2014 11:03 AM Flag

    Clinically they might know the results from testimony by the doctors who conduct the clinical exams, but statistics has to be applied to the numbers associated with laboratory results, image results, biopsy results, etc. It takes months to compile all the data and arrange it in proper tables for analysis and then presentation to the FDA. Been there, done that. I wrote most of the IND for Biopure's blood substitute plus lots of NADAs.

    GLTAL

    Sentiment: Strong Buy

  • to begin a second clinical trial with the same vaccine if it had failed at one mucous membrane anatomical site. What would make it work at a much more challenging site like the oral cavity, head and neck? Even if the adjuvant makes the local immune reaction more high powered, the basis of the treatment is the DNA vaccine. I think Dr. Kim is going to get a retraction from SA and the "contributor" has placed the company that hired him as a commentator in serious jeopardy. Lets see how Inovio pursues this because the contents of the SA article were totally speculative and directed to facilitate the professional day traders, manipulators, etc. BTW, the head guy at SA is a hedge fund executive, so you can guess what he is all about.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Jun 10, 2014 11:33 AM Flag

    Had some bonds pay dividends so I placed and order for 250 shares of INO at $10.80/share last night and it filled this morning!?! I was up at 5 AM kicking my behind for procrastinating . . . but then every now and then I get lucky. I am usually not lucky . . . but go figure.

    GLTAL

    Sentiment: Strong Buy

  • 1. It is unequivocal that Inovio was allowed by the FDA to initiate a Phase IIb (Phase III enabling efficacy clinical trial) for the same vaccine (against HPV) at a different anatomical site because there was convincing evidence of safety in the HPV cervical vaccination study.

    2. While this new trial only alludes to a probable result from the cervical cancer trial, it is highly conclusive that the FDA is allowing a parallel study to follow the epidemiology of the HPV (virus).

    3. This "follow the virus" therapeutic strategy is clinically important because it is going to promote the systemic applications for vaccines and account for different GENDER PREDISPOSITIONS of certain types of cancers. Only a woman can have HPV cervical cancer and mostly men contract HPV head and neck cancers.

    Bye, bye stupid bashers!

    GLTAL

    Sentiment: Strong Buy

  • posters should totally ignore the past and just concentrate on fact finding about the science, progress and milestones reached by Inovio. There will be no more "clutter" on the MB so Longs can focus on intelligent conversation and reality.

    Sentiment: Strong Buy

  • clearly indicates the potential for PV-10. But the approval pathway for a drug (particularly a cancer drug) is ponderously slow. I worked with physicians at Dana Farber for 22 years doing translational/comparative medicine to establish preclinical safety data. Getting a drug through the regulatory pathway and any clinical trial takes years and a good clinical trial protocol. This would be a stock that someone familiar with drug development would buy and hold onto to put their grandkids through college. Not even necessarily their kids unless they were real young. The lawsuit will fail at its face based upon what I saw. What the attorneys are going to have to prove is that management cannot make the drug reproducibly (which is a requirement to start a Phase III clinical trial) and that management had anything to do with the MMs, day traders, pumpers and bashers on the MB. But here is the head's up - the SEC regards MBs as "blogs for ideologues" because the info on MBs is managed by the server/browser and not the SEC. It is strictly being able to perform your own DD versus what you read on a MB. Good luck, but this is a hold stock for years with slow accumulation to get a return on your $$.

    GLTAL

    Sentiment: Hold

  • When a Sponsor initiates a Phase III Clinical Trial, there are several facts that must be in place before the first patient receives a dose:

    1. The final drug formulation must be characterized. This is the composition of drug, liposome agents and vehicle which will constitute the final product. There can be no changes in formulation in a Phase III.

    2. The final drug formulation must be demonstrated to be "reproducibly manufactured" by a process that can be certified according to Good Manufacturing Practices (cGMP) regulations by the FDA. This means that each batch will be essentially the same in terms of formulation.

    3. And the Sponsor and FDA or EMEA/CHMP have agreed as to the dosing and endpoints which will demonstrate efficacy (ability to kill bacteria).

    Interestingly, several the inhalational antibiotic liposomes products recently have focused on FEV1 (force expiration volume) testing as the primary endpoint and reduction of bacteria as secondary. Not sure why, but the liposomes appear to ease breathing before they have a major effect on killing bacteria. The special aspect of Pulmoquin is that systemic Cipro can be administered simultaneously with inhalational Cipro. That has a tremendous value added in clearing lung infections and stopping any spread from the lungs. This is achievable because of the low toxicity of fluroquinolones compared to aminoglycosides and macrolides.

    But we shall see.

    GLTAL

    Sentiment: Strong Buy

INSM
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