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Insmed Incorporated Message Board

rehdvm2004 58 posts  |  Last Activity: Jun 21, 2016 6:26 PM Member since: Oct 21, 2004
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  • Why would a patient want to take a "pill" (twice per day) for a lung infection when your could inhale a mist of the same antibiotic for 10 minutes and achieve the same result (without side effects from taking a pill)? The antibiotic does not have to be absorbed from the GI tract, equilibrate in the blood, circulate to the lungs (the infected organ) and kill the bacteria. And do this twice per day.

    Instead you inhale a mist for 10 minutes, and sit back and watch TV for the rest of the day. OOPS! I inhaled my dose one hour late. FM! But it still does not matter because the dose was inhaled, is accumulating directly in the lungs where the infection is challenging the patient . . . and guess what . . . killing the bacteria. The bottom line for ARDM is the logs of killed bacteria (Pseudomonas aeruginosa or Mycobacterium species other than TB and the number of patient that have "ZERO" bacteria in a sputum sample after 28 or 56 days.

    EOS.

    Based upon my treating animals for the same conditions we are describing for humans . . . I think liposoma Cipro once per day is a more easily administered and therapeutically beneficial outcome. But let's wait and see what the clinical trials data reveal. I would be surprised if ARDM does not surpass the results achieved for TOBI, Arikayce, Zith and others. Just my impression from treating 43 years of animals with respiratory infections.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    OT ... Check out PRTK

    by la.taupe Jun 17, 2016 7:27 AM
    rehdvm2004 rehdvm2004 Jun 21, 2016 5:07 PM Flag

    ARDM is liposomal Cipro for respiratory infections . . . while PRTK makes a novel tetracycline for skin infections and rosacea. Those dots do not connect or run in parallel. That is how you should contrast the two different categories of antibiotics. I know because I took Cipro for various infections (respiratory, cellulitis of the skin in my leg from a Brown Recluse Spider bite, and sinusitis). Cipro works well. Also took short treatments for rosacea and ureaplasma with doxycycline, so I know that antibiotic. So what you are proposing is "diversification" of investment in novel antibiotic?!? That is what it is on the face of the facts.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Jun 21, 2016 11:36 AM Flag

    I post this same info from time to time. Almost all (I do not know of any, but . . .) vaccine batch release test require dosing mice with the vaccine, waiting the required period for eliciting neutralizing antibodies and the challenging one group of mice with saline (or the vaccine vehicle where all animals are expected to live), one group with a low dose challenge of live infectious agent (again all are expected to live), one group with an intermediate dose of live infectious agent (all or most are expected to live) and one group with a high dose of live infectious agent (these mice got the short straw and most succumb). Then based upon an calculation, the manufacture puts the vaccine into vials (final product) and then they test the vaccine all over in mice again to make sure that a statistically significant number of vaccine vials have the same level of protection.

    So stupid comments like "the vaccine saves mice" . . . are just that ignorant . . . uninformed basher attempts to demonstrate they are who they are.

    GLTAL

    Sentiment: Strong Buy

  • Inovio is on the cusp of several break through vaccines that will be the "way forward" for pediatric and adult vaccinations for the next century:

    1. DNA Zika;
    2. DNA Ebola;
    3. DNA Hep C and not to be forgotten;
    4. DNA HPV for an alternative to cervical surgery and head and neck therapy.

    Take your pick each is a $Billion market.

    Look to marketing in 2017.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Jun 19, 2016 2:47 PM Flag

    PS - That is not even counting the cancer vaccine projects.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Jun 19, 2016 2:46 PM Flag

    Inovio has many clinical trial prospects that are going to take a lot more $$$ in the next two years. Zika and Ebola on the infectious disease side, but these are currently infrequently transmitted and non-existent in the US. However, Inovio has also started vaccine studies on the No. 1 most transmitted and fatal disease in the US according to CDC. I get the alerts sent to my main e-mail and was shocked to find out what they announced on the Infectious Disease Advisor on June 10. Hepatitis C. So yes, Inovio needs more cash to keep all their trials moving along, but the benefit to risk ratio is worth every penny of buying more shares. Dilution is only self serving if there is no progress being made for at least one project. Inovio has quite a few that are progressing.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Newest Annual Report and Proxy Statement

    by walktheline43 May 25, 2016 7:32 AM
    rehdvm2004 rehdvm2004 Jun 1, 2016 9:49 AM Flag

    They went with EMEA because Grifols is located in Spain, they have an "knowledgeable inside regulatory track" in Europe and the filing through ICH (Harmony) would be expedited anyway. I think that some of the hospitals that are participating are in the US and Canada, so the cross-filing is just a technicality. If they get two or more logs of kill against either Pseudomonas aeruginosa or Mycobacterium species . . . Pulmoquin and/or Lipoquin are going to be approved.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    DD that is not debatable . . .

    by rehdvm2004 May 29, 2016 4:23 PM
    rehdvm2004 rehdvm2004 May 29, 2016 4:25 PM Flag

    Inovio's vaccines, for example are producing detectable levels of neutralizing antibodies against more than 95% in animals (mice and monkeys) and humans.

    Do you homework and accumulate. In the end, it will pay off.

    GLTAL

    Sentiment: Strong Buy

  • The process that the FDA (and other international regulatory agencies subscribe to) requires a specific process be followed for the filing of a Biologics License Application (BLA) to gain approval in the USA. The basic precepts can be learned by going to the FDA website and searching: "Vaccine Product Approval Process." This information is provided by CBER (Center for Biologics Evaluation and Research). There are other facets of vaccine approval that are also available at the FDA website, so keep going until you have all the answers you need for your edification. If you read this information and understand the concepts . . . you will understand why stocks for drugs, vaccines and (to a lesser extent) biomedical devices can be shorted ONLY by mockery of the facts. The regulatory milestones are so integrated by scientific principles that the monthly ups and down created on MBs is ludicrous. When you invest in a bio stock, here is what you are investing in . . . long term improvement of human (and animal) health by therapeutic or preventive medicine. EOS.

    So if you search further on the FDA website, you can search information about specific approved vaccines. I did this as an example for this post. "H5N1 Influenza Virus Vaccine, manufactured by Sanofi Pasteur, Inc. Questions and Answers:" The information described the protocol for immunizations (two) and the numbers immunized. The answers went on to describe "The 90 microgram two-dose regimen produced levels of antibodies expected to reduce the risk of getting H5N1 influenza in 45% of those who received it. Although the remaining individuals did not develop this level of antibody, current scientific information on other influenza vaccines, suggests that less than optimal antibody levels may still have the potential to help reduce disease severity and influenza-related hospitalizations, and deaths." So here is information on a recently approved vaccine that protects only 45% of the people immunized.

    more

    Sentiment: Strong Buy

  • Reply to

    The Animal Rule Regulations

    by rehdvm2004 May 29, 2016 10:19 AM
    rehdvm2004 rehdvm2004 May 29, 2016 11:35 AM Flag

    One thousand people in the middle of Brazil (at the Olympics?) who were exposed to the Aides egipti mosquito (daytime biter, WHO has world maps where these mosquitos are concentrated) compared with 1000 people who are not vaccinated can statistically tell a lot. For one thing, if a person already has neutralizing antibody to Zika and they get infected, their titer will go down for a day or two and then go up dramatically. That is what the immune system does. Produces antibody to foreign (invading infectious agents) which will rise above baseline titer until the infection is thrown off. If the antibody is not protective, guess what . . . the person bitten will have a fever because they were not protected from infection. So if you compare 1000 vaccinated against 1000 unvaccinated and monitor them for fever and the changes in antibody that accompany exposure to mosquito borne Zika, you should be able to make a medical judgment as to whether the vaccination is protective.

    In a related matter, Chembio (CEMI) just got a big grant to make a DPP test of Zika. They are already working on a multiplex test for "several agents which cause a fever."

    GLTAL

    Sentiment: Strong Buy

  • There was a thread that put the Animal Rule Regulations in an incorrect prospective. The Animal Rule Regulation (Guidelines for Industry) clearly state: "This guidance (Reference 2) provides information and recommendations on drug and biological product (Reference 3) development when human efficacy studies are not ethical or feasible." There are no human vaccines that are beyond the capability of detecting neutralizing antibody production to live virus in a test tube (in vitro test) or by vaccinating people and placing them in situations of high risk where exposure is likely (similar to the Phase I Ebola vaccinations in West Africa). The Sponsor would then determine how many of the people vaccinated did not contract the disease versus the incidence in the same surrounding population that was non-vaccinated. Of course there can be no direct challenge of the vaccinated person with the disease agent. The likelihood that a vaccine could be tested for safety in humans before the Olympics is very remote. But completing a Phase I (Basic safety and dose response) study in humans by the last quarter of this year is feasible. Then the Sponsor would vaccinate 1000 people in the face of the expanding human infection pathway and see how many of those people were protected and did not contract any clinical signs.

    GLTAL

    Inovio and GeneOne are on target.

    Sentiment: Strong Buy

  • Reply to

    Gene therapy drug approval granted to GSK

    by sewynegar May 29, 2016 8:30 AM
    rehdvm2004 rehdvm2004 May 29, 2016 9:51 AM Flag

    Vertex based in the Boston area now has two oral preps approved to modulate cystic fibrosis clinical pathology. The concept is not new and is a treatment methodology that will be heavily investigated during the next 20 - 50 years.

    Inovio is a part of this new future for therapy.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Newest Annual Report and Proxy Statement

    by walktheline43 May 25, 2016 7:32 AM
    rehdvm2004 rehdvm2004 May 25, 2016 11:05 AM Flag

    Successful Phase III results are held in confidence between the Sponsor and a regulatory body until there is full collation, statistical analysis and submission. That starts a regulatory clock for mandatory response from the regulatory agency. So public announcements other than hitting regulatory milestones are essentially not possible for a Sponsor.

    A slight exception to this regulatory situation is allowed when a participating medical center finishes their part of a Phase III, submits their data to the Sponsor who unblinds, collates and analyzes the data and finds a positive result prepares a paper, poster or seminar for a scientific meeting. This is only allowable when the data analysis conforms to the criteria set up with the regulatory agencies which will review the final data. This exception is also allowed because it is the physicians at the collaborating medical centers that report safety and efficacy of the treatment. So in essence, a subset of data can be presented if it is exclusive to one or just a few institutions that participated in the clinical trial. NIH does this all the time. Dr. Kenneth Olivier has published on Arikayce and that negotiation with FDA has been going on for over a year. The regulatory process is a collective search for wisdom, but it is laborious and slow.

    Relative to ARDM, I expect something pertinent about September, when the clinical findings of last enrollees are analyzed. One of the big med centers will probably publish the primary and secondary clinical objectives have been met.

    I was surprised by two facts recently. ARDM enrolled 584 (?) patients which was more than 200% of their agreed upon 255 enrollees with FDA and the enrollees included NTM patients. This latter includsion is a biggie.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Fauci and INO Zika Vaccine

    by awalkinthejungle May 19, 2016 8:09 AM
    rehdvm2004 rehdvm2004 May 19, 2016 9:42 AM Flag

    What he is responding to is whether there is a collaboration over Zika Virus. Not for other infectious agents where there are collaborations. Besides, Fauci and his colleagues could be ignorant of other Inovio-US Government collaborations. He may just be familiar with his small group and not the US Government in general. This is not a situation to take very seriously. Besides if GeneOne and Inovio can develop this thing independently . . . the profit margin is huge. Lets wait and see where the $622 million go for Zika research. It might go to NIAIS, DARPA, CDC, ???

    The important part is that Inovio has completed their monkey study, which is a "higher" species that usually allows a Phase I in humans.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    584 patients enrolled . . . including . . .

    by rehdvm2004 May 17, 2016 8:43 AM
    rehdvm2004 rehdvm2004 May 19, 2016 9:13 AM Flag

    The original study that was approved in 2013 was for 255 enrollees. The number 584 is more than twice that number. The data may be broken down into the Pseudomonas aeruginosa patients and the NTM patients. If this is the case and there were two populations of enrollees based upon achieving statistically significant subpopulations of bacterial infections . . . the general (physicians) prescriptive label copy could be for just bronchiectasis, regardless of what bacteria caused the infection. It would come down to what bacteria in a sputum sample could be cultured and what the antibiotic sensitivity testing demonstrated (i.e., sensitivity to Ciprofloxacin). This possibility has significant ramifications for eventual NDA submission.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    VGX-3100 an Alternative to Surgery

    by lisannikki May 4, 2016 11:53 PM
    rehdvm2004 rehdvm2004 May 18, 2016 8:21 PM Flag

    Posted this same fact several times, but it is more powerful statement coming from a female investor.

    I have always contended that women have 51% of the say about women's things and men have 51% of the say over prostate things. The rest is a coin flip.

    Any vaccination alternative to surgery should be heralded as a breakthrough therapy. But not by stock manipulators.

    GLTAL

    Sentiment: Strong Buy

  • If you look at the CDC and Wikipedia info, there is important information to understand. Zika was first isolated from monkeys before 1950. It was classified as an ARBO (arthropod borne) disease. It caused sporadic disease outbreaks in humans from because of zoonotic (animal to human) transmission by "interrupted blood meals." An interrupted blood meal is where a mosquito starts to suck blood from an infected monkey, gets chased away by the monkey and then bites a nearby human. So the original virus was primarily in monkeys and occasionally infected humans. Now there have been so many human cases that the interrupted blood meal involves human to human transmission. The virus has adapted to humans and is carried by humans. Hence the WHO and CDC status of "pandemic" or world wild outbreak.

    So the take home is that a Zika Virus vaccine is urgently needed to stop human to human transmission and further spread. The serious effect on the fetus and neonatal infants is the focus of the need for a vaccine. This vaccination is likely to be "universally prescribed" by pediatricians and physicians in the future.

    Curiously, this virus is sexually transmitted . . . so be sure and chase the mosquito off the skin of your partner . . . if you see one.

    GLTAL

    Sentiment: Strong Buy

  • patients with chronic NTM induced bronchiectasis. So by focusing on bronchiectasis and not a particular bacteria . . . ARDM has developed a broader potential label copy for its products. The CT scan also is an imaging method that allows digital enlargement and evaluation and can show whether the actual lung scaring is static . . . or hopefully resolving slowly. We shall see, but the NTM cases change the entire picture for the two preps.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 May 16, 2016 8:52 AM Flag

    That is why you put them on ignore! Right?

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    60 Minutes tonight:

    by ipdup May 15, 2016 5:06 PM
    rehdvm2004 rehdvm2004 May 16, 2016 8:50 AM Flag

    While the Duke modified polio virus is different . . . what it suggests is that medicine is entering into the next generation of multiple modality cancer therapy coupling immune modulation with cancer cell apoptosis (versus normal cell apoptosis). Apoptosis is cell death. Watch and feel secure that the future will cause many cancer to be susceptible to the most powerful life preserving system in the living being . . . the immune system.

    GLTAL

    Sentiment: Strong Buy

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