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Insmed Incorporated Message Board

rehdvm2004 3387 posts  |  Last Activity: Jul 12, 2014 7:31 PM Member since: Oct 21, 2004
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  • 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

  • Reply to

    Critical statement because . . .

    by rehdvm2004 May 27, 2014 8:42 AM
    rehdvm2004 rehdvm2004 May 27, 2014 9:34 AM Flag

    If you could treat the patient before any prior therapy has been ineffectual and no antibiotic resistance had occurred . . . would that not be better? You can still Rx patients after the failed therapies, but any doctor or medical person would want to treat with the best medicine first. Ask you doctor about what he/she would prefer to treat you with if you got NTM. A drug that works, or a bunch of drugs that waste time and $$$. Typical of myopic paper pushers who never understood medicine in the first palace. I see that fudfool chimed in. TB of any kind was purposefully excluded from Arikayce protocols because that would have required 10 years to get approval. Stock dopes have zero understanding of medicine and it taints everything on this MB.

    GLTASL

    Sentiment: Buy

  • For those of you around 40 years old, this company would be a great investment. The reason is that there are many animal diseases that need to be controlled for food production and human health protection in the future. For example, the reason that we vaccinate against rabies is the fact that rabies can get to our pets and pets have access to homes and people. The Germans invented a "bait rabies vaccine" years go that vaccinated the rabid foxes in the Bavarian Forest so they could eradicate the last vestige of rabies from Germany and Austria. This has been used to control raccoon rabies in the NE. Dog rabies has not occurred in the US in many years. Cat rabies occurs rarely because the state laws about vaccinating cats is variable and cats get exposed to weird forms of rabies like bat rabies. Even Mexico has rabies free areas around the big tourist centers (Cabo, PV, etc.).

    As for animal diseases, the first vaccine for PRRS is going to save the swine industry from pneumonia and poor growth among a significant fraction of animals. Then maybe Gates will get involved to develop a vaccine against malaria in monkeys. Malaria is seldom transmitted from human to human. Mostly it is transmitted from monkeys in the wild to humans. And the monkeys are more resistant to dying from malaria than humans so one infected monkey can infect many mosquitoes that can fly a few hundred yards to bite a human. Monkeys are the natural reservoir host for Falciparum Malaria.

    I am going to look into investing in this technology because all good therapies for humans trickle down to animals.

    GLTAL

    Sentiment: Strong Buy

  • "It was observed that 21 of the 68 patients eligible were culture negative for NTM at the end of 168 days. In addition, the number of patients with negative cultures increased from the double blind phase of the trial."

    Because ALL of the patients enrolled had undergone 6 months of failed therapy from any other recommended forms of therapy. That includes exposure to various systemic antibiotic regimens.

    The future of Arikayce rests with the first repeated NTM culture form a patient who has never had NTM infection before (naïve patient) who is started on Arikayce immediately after the second positive culture. This would be before any of the serious long term (chronic) infection damage to the lungs from multiple infectious foci and tissue damage becomes clinically significant.

    GLTAL

    Sentiment: Buy

  • Reply to

    40 to 1 reverse stock split

    by raymondjonker May 23, 2014 10:38 AM
    rehdvm2004 rehdvm2004 May 25, 2014 12:46 PM Flag

    That appear correct. I just checked my Fidelity WROS account and I had 500 shares at $7.10. Phase III has started which is probably a milestone payment from the partnership. We shall see.

    Sentiment: Hold

  • rehdvm2004 rehdvm2004 May 21, 2014 12:36 PM Flag

    The critical difference for the future is that a Phase III for NTM will include naïve patients that do not have to go through the 6 months of predictably non-efficacious treatments required for enrollees of the Phase IIb trial. The 25% should double or triple in a Phase III with NTM positive, never treated before patients.

    For Pseudomonas aeruginosa, it will be the results of the culture and sensitivity test. Which inhalational antibiotic is most efficacious for that strain of Pa. This will be totally dependent upon culture and sensitivity testing. Just like any other bacterial infection in a tissue or organ.

    The critical factor will be the next WL announcement of regulatory negotiations on both sides of the pond.

    GLTAL

    Sentiment: Buy

  • rehdvm2004 by rehdvm2004 May 13, 2014 12:22 PM Flag

    Anyone interested in due diligence should do a PubMed (Medline) search through the NIH web search services and enter: "bin wang" AND "alzheimer's" disease and see what comes up (six papers). The science Dr. Wang is following is up-regulation of antioxidant and enzyme metabolism in the brain. This parallels, for example, what Vertex has developed and obtained FDA approval for in treating two cystic fibrosis gene mutations and other diseases by other companies as well. The day traders who do not know (or care) about the science associated with a medical-scientific company will continue rale until Inovio lands its first big FDA approval. But they are also the ones suggesting that climate change is a hoax. So Longs need only wait-out the clinical trial and regulatory approval pathway and turn a blind eye towards the "paperhangers" input to this MB.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 May 3, 2014 8:27 PM Flag

    When used at "in situ" (into the tumor) at the tiny amounts used for immunizations? The immune response has no "dose effect" and the worst case is that an allergic reaction can occur to a vaccine. Allergic reactions can become anaphylaxis, but that is fairly rare. Where did you read this "science?" NIH? Peer reviewed journal? Just give me the initials and I can

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 May 3, 2014 8:23 PM Flag

    The ministries approved clinical trials, not marketing. You are just as bad as harry only in the other direction. Regulatory approvals to market are required. Not regulatory approval to perform a clinical trial.

    Look at Italy and Iplex for ALS as an example. The Italian government approved a case-by-case use of Iplex to treat Lou Gehrig's Disease (ALS) but the data was so scattered they could not get approval to market. INSM rejected an FDA/EMEA request to do a Phase IIa/b. Iplex is now gone for ALS. Even though 29% of the patients had improved muscle function and swallowing. Eventually, all ALS patients get aspiration pneumonia or "drown" in any fluid they ingest because their swallowing reflex disappears. But you are misinforming investors by pumping false information. Iggy!

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 May 3, 2014 8:16 PM Flag

    Inovio Longs should understand a few simple facts:

    The MB is for a few people who try to "reason through" headlines of filings from INO and a few who in the interests of DD try to bring a little science or regulatory understanding to the MB.

    The vast majority of posters are "MMs", "MM wanabees", day traders or pumpers who are just trying to get shares moving. Up, down, does not matter. Just "sell your shares." Ever notice that for every "seller" there is a "buyer?" Volume and SP movement it ALL it is about. Truth is, no retail investor should pay any attention to this BS!?! If you ask the SEC, they say these MBs are BLOGS that are personal opinions and mean nothing. Write the commission and ask.

    But supporters of INO need to understand the fine line between recommending a position of accumulation and "pumping." I once got a specific e-mail from a biotech CEO telling me to refrain from commenting on scientific information his company had developed and which I was trying to get him to think of in a different way. I was suggesting that rather than licensing to produce other institutions diagnostic tests, he search and find one that his company would own as a proprietary product. He did not listen, he is gone and the scientific review board of this company is refocusing their patent along the lines of the suggestion I had made.

    Point is, INO is a company based on science and medicine. That is where the answers to INOs future will appear. Not on this MB. Posts here can only redirect an investor to look at objective, meaningful sources of information.

    The HPV vaccine study is "Active, Not Recruiting" and was last updated April 2014. The important part is "Active" (compiling data) and "Not Recruiting" (they have enrolled the 148 patients) agreed upon with the FDA/EMEA. Now we need the results of the "top line data" which is now supposed to be available in June. So in 2011, INO said the data would be out in April. Good guess.

    GLTAL

    This messa

    Sentiment: Strong Buy

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