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Insmed Incorporated Message Board

rehdvm2004 52 posts  |  Last Activity: Aug 24, 2015 6:43 PM Member since: Oct 21, 2004
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  • Reply to

    FAST TRACK APPROVAL: EBOLA & MERS

    by lingr99 Aug 20, 2015 3:39 PM
    rehdvm2004 rehdvm2004 Aug 24, 2015 6:43 PM Flag

    It makes a difference after the results of a clinical trial are collated, statistically analyzed and submitted. Fast track gets a 90 day turn around of either approval or questions to be answered, which starts another 90 day clock when the additional data is submitted.

    Under "break through drug" "fast track review" the fastest any drug has reached market is 27 month. According to the FDA website.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    FAST TRACK APPROVAL: EBOLA & MERS

    by lingr99 Aug 20, 2015 3:39 PM
    rehdvm2004 rehdvm2004 Aug 24, 2015 6:40 PM Flag

    The standard for initiating a clinical trial anywhere in the world is largely described in the ICH (International Conference on Harmony) which standardized the criteria for making drugs, biologics and medical devices and established the sequence and scope of safety and efficacy testing (the latter is the methods by which clinical trials are performed). Your statement about stupid people reflects upon you, not other investors posting on this MB.

    Undocumented and mismanaged clinical trials in Africa for HIV infected individuals was rampant during the 1990s and became the subject of a movie, "The Constant Gardener." You have to submit a clinical trial protocol to a regulatory body in order to make sure the results are reliably accurate. You should look at the protocols that Inovio has online at their website to educate yourself before you make such a preposterous statement.

    GLTAL Iggy for bdfm.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Aug 19, 2015 7:04 PM Flag

    If any Long was remotely affected by the dead mice bashers . . . you have more serious problems than an infectious disease . . . you need your head examined for brain malfunction!?!

    GLTAL

    Sentiment: Strong Buy

  • "WHO Guidelines document for Malaria Vaccines (but the testing principle applies to all vaccines)"
    "Methodological considerations: Potency tests for recombinant adjuvanted RTS,S vaccine"
    "In vivo potency tests"

    "The RTS,S adjuvanted malaria vaccine includes two antigenic determinants, S and CS, for which two quantitative in vivo potency assays are performed for characterization purposes. Both of these assays are immunogenicity assays in mice.

    A suitable quantitative potency test in mice is as follows. Groups of 10 mice, between six and eight weeks of age, are immunized two times subcutaneously with a 14-day interval with a series of dilutions of the reference and test vaccine using the vaccine reconstituted with the adjuvant system. The strain of mice used for this test must give a suitable dose-response curve with the reference and test vaccine. Terminal bleeds are taken when an adequate antibody response has developed. Individual sera are assayed for either antibodies to S or antibodies to CS using an enzyme immunoassay.

    The concentrations of vaccine administered to mice should be selected to permit the calculation of GMTs for anti-S response and of anti-CS GMTs. Then the relative potency of the test material is determined as the ratio of the GMT of the test sample to the GMT of the vaccine reference material. The relative potency should be within limits established by using a suitable statistical approach based on consistency data gathered on both clinical and commercial lots.

    Points which should be considered in establishing such an assay include:

     The strain and sex of mice used must give a suitable dose response to the reference and test vaccine.
     The number of mice per dilution required to meet the validity criteria of the test.
     The number of dilutions of the reconstituted adjuvanted vaccine and the appropriate selection of doses to
    be tested." (further)

    BTW, scientists are always adding "ed" or "ized" to nouns to create new verbs.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    EMA Approval Prospects

    by tycint Aug 13, 2015 7:43 PM
    rehdvm2004 rehdvm2004 Aug 16, 2015 5:29 PM Flag

    The tentative diagnosis of NTM is accomplished with pre-culture staining of acid fast cocci from a sputum sample from patients that have a dry, marginally productive cough and have a history of exposure (exposed to soils, poor quality water, other environmental factors that create soil aerosols). The acid fast staining technique takes 10-15 minutes. That creates a differential diagnosis between NTM and TB. If it is the latter, there are bigger problems and Arikayce is outside the scope of useful Rx because the cell wall lipids are different and are created differently TB from NTM. Just the facts. But TB exposure is very different. It is a people to people disease. Does not linger in the environment. Clinical history will guide the physician to initial Rx. The therapeutic fork in the road is if you get acid fast is (simply) if there is no exposure to a TB positive source, Rx for NTM. Simple. Consult the basic Dr. Kenneth Olivier papers.

    GLTAL

    Sentiment: Buy

  • Reply to

    EMA Approval Prospects

    by tycint Aug 13, 2015 7:43 PM
    rehdvm2004 rehdvm2004 Aug 16, 2015 9:47 AM Flag

    Arikayce will be approved. Questions about certain aspects of the filing are common, even with breakthrough applications. The regulators just want a question answered a certain way. 120 day clock is still pretty fast track if it is just presenting a different set of data that INSM already has, but did not present in the application or presented it in a way that was unclear. I would believe that from the data I saw and the position taken by Dr. Olivier of NIH that Arikayce for NTM will be approved by the end of the year and will be widely marketed in 2016. Just a huntch, but seems reasonable. The important aspect of Arikayce for NTM is that it will become the first choice for therapy when NTM if first isolated from a patients sputum and that with Arikayce treatment, the chronic infections and pulmonary damage from that genera of bacteria will fall way off from current levels and severity.

    GLTAL

    Sentiment: Buy

  • rehdvm2004 rehdvm2004 Aug 10, 2015 10:05 AM Flag

    Of course the scientific DD will ultimately determine the likely outcome, but the process is so complicated and slow that many investors, day traders and manipulators cannot "flash trade" and make their short $$$ quota for the day. If you go to the FDA site and look at the time to approval for a "breakthrough" filing, there are only three that go approved in less than 30 months. That is why I always apply the 3 year standard for my investments. Some sort of a clinical milestone or valuable collaborative deal has to occur to meet my projection. I bought in March 2013 and projected something would happen by March 2016. Guess what. Many things with strong beginnings have happened and Inovio is growing stronger (scientifically) and meeting milestones. My guess is there will be another two or three important steps forward by March 2016, or consolidation of a current position.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Is this a de facto merger with AZ?

    by geezerbela Aug 10, 2015 8:45 AM
    rehdvm2004 rehdvm2004 Aug 10, 2015 9:17 AM Flag

    I think there is interest both ways, but to be precise, you are correct. The INO 3112 study is their DNA vaccine against HPV with the IL-12 added to get an even stronger T-cell response. This is, in my view, the second generation of the first HPV DNA vaccine that Inovio has taken through Phase IIb. So what does this mean? Inovio has a contract with Medimmune to perform the clinical trials and manufacture INO 3112. Probably the world wide rights will follow, or are already a part of the deal. In this way, Medimmune will probably get the entire entity through regulatory and be filing for approval in three years. They will also be providing a cGMP manufacturing capability to produce millions of doses per manufacturing run and get the doses anywhere in the world the vaccine is needed. Remember, the HPV vaccine was both preventive and therapeutic. This will be the model for other preventive/therapeutic cancer preparations in the future. Inovio is not likely to be bought out over one vaccine. They will also need to make progress with their other vaccine projects with GeneOne, UPenn, etc. The focal point will be whether then next DNA vaccine really presents a "breakthrough" for some type of cancer or some type of infection.

    GLTAL Longs have outdistanced the bashers.

    Sentiment: Strong Buy

  • Reply to

    Potential valuation

    by walktheline43 Jul 31, 2015 11:03 AM
    rehdvm2004 rehdvm2004 Aug 5, 2015 9:45 AM Flag

    I think the valuation will maybe go 4X by clinical trial completion date and higher when the CF and other application clinical trials get started. INSM has been meeting most of their clinical trial milestones since 2009 and they are still in the process of completing their applications to EMEA and FDA. They are in the initial Q&A period after filing the BLA in the US, Canada and Europe. The process is tedious and protracted. No experienced investor buys into biopharma thinking the filing is "just around the corner" let alone the approval from a regulatory agency. Three years is the best you can hope for with the initiation of a Phase III.

    GLTAL

    Sentiment: Strong Buy

  • ARDM completes its study on Pulmoquin and Lipoquin in July 2016. Current status is "still recruiting." They have 255 patients to enroll. ARDM has 104 sites recruiting patients.

    By comparison, Bayer has its powdered Cipro study slated for completion in December 2016. They indicate they are trying to recruit 450 patients into their study, but they have more than 200 sites recruiting.

    This is a horse race, but the two inhaled antibiotics are different in their chemical composition. The lipid outer coat on Pulmoquin and Lipoquin makes them large enough for uptake by the fixed macrophages in the lungs which makes the antibiotic effect more prolonged. Also, many of the infections of the lung become concentrated in fixed macrophages, which are the vacuum cleaner cells of the lungs and present bacteria or foreign materials to the immune system.

    This is a horse race, but both started in April of 2014 and both are scheduled for completion in 2016.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Dengue fever DD

    by rehdvm2004 Jul 29, 2015 3:17 PM
    rehdvm2004 rehdvm2004 Jul 29, 2015 3:38 PM Flag

    Dr. Stephan Whitehead is still there and the guy working on the antibodies is Dr. Pierson. Went back and looked for references on the NIH site.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Jul 29, 2015 3:17 PM Flag

    There are two different categories of Dengue fever infectious disease - the one that causes flu/headache symptoms which is generally treated symptomatically until recovery after a week and the serious kind (1% of cases that need hospitalization and intensive therapy). If investors do their DD, they will see the value of a DNA based mAB because there are no antivirals and no vaccines for the five strains of Dengue virus. I worked at CRL years ago and we studied the five strains and antigens that Dr. Whitehead and the main guy in that NIH laboratory (I forget his name) had isolated from mosquito trappings in Asia and Central America. Dengue got to Panama in the 1990s and has been coming up the tropical coastal areas of Mexico toward the US for 20 years. This is a wide open, non-competitive therapeutic market. Watch this one carefully for the next three years.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Chembio needs to think in broader terms . . .

    by rehdvm2004 Jul 18, 2015 8:57 PM
    rehdvm2004 rehdvm2004 Jul 19, 2015 7:24 AM Flag

    The brains behind Chembio is the Dr. E who invented DPP. Worked with Chembio in 2007-2008 to get new products, one of which was a biggie. Then I sold at $4 and made $20 k which I re-invested in biopharma in Fidelity. Not a big hit, but OK. I do not short any stock. Know the regulatory path and stick it out. Usually hold for 3-5 years before any decision because of the slow regulatory path.

    As of immunotherapy for cancer, it is simple . . . many companies are going for immunomodulation and immunotherapy against cancer. The need to know what they are shooting at. Chembio has the best POC design which can be used for lots more applications than they are promoting. Infectious diseases are the old application, but you have to own the antigens and antibodies to make a killing at $4.50 per test unit. That is the overhead cost of production and if you pay a 20% royalty for the stripes on the DPP, you profit margin is down by 90 cents per unit.

    I was high on the DPP because it had more sensitivity than Luminex (a fluorescent antibody test). Did the study at CRL.

    But this is moot because Dr. Cornelia Trimble has the patent on the test reagents for HPV. Chembio should talk to her.

    GLTAL

    Name one other moniker that I use. You cannot because there are none. Iggy

    Sentiment: Buy

  • This was impossible under LS leadership. But who knows what the new scientific leadership might consider.

    An entirely new area is opening up to POC. It is the methodology associated with cancer immunotherapy. Just imagine the ability to map the therapeutic potential for a patient by a simple swab. Just like the HIV test, but for cancer. Not an infectious disease. Infectious diseases will always be recurring and changing (mutation and amplification) but cancer is being unmasked to "present to the immune system" of the patient.

    Mark my words. This is the future of therapy and POC.

    GLTAL

    Sentiment: Buy

  • Reply to

    Preview of VGX 3100 Peer Review

    by danwebs2014 Jul 18, 2015 11:07 AM
    rehdvm2004 rehdvm2004 Jul 18, 2015 4:12 PM Flag

    Forgot

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Preview of VGX 3100 Peer Review

    by danwebs2014 Jul 18, 2015 11:07 AM
    rehdvm2004 rehdvm2004 Jul 18, 2015 4:12 PM Flag

    Here is why this is important. The method of therapy and/or prevention that Inovio is promoting for HPV is immunogenic. So since there are strains of the virus that cause the disease, and there are variable responses to the viruses from the patients own immune system, being able to semi-quantitate the degree of response to each of the strains of virus will be used to direct the course of immunizations. Also, if the response is variable (strong in some and weaker in other patients) during the course of treatment, the test can be used to shorten or prolong the course of therapy. I am going to look up the USPTO file by Dr. Trimble and see what else might be there, but an unknown (or unappreciated part) of the Inovio approach is the fact that the whole basis of therapy lends itself to an immune based POC (Point Of Care) diagnostic test method. In this case, the faster the better.

    Sentiment: Strong Buy

  • Reply to

    Ebola

    by sonomaca Jul 6, 2015 10:54 AM
    rehdvm2004 rehdvm2004 Jul 15, 2015 10:52 AM Flag

    The DPP is ideally suited to an Ebola POC test provided that Chembio has ALL the different Ebola antigens to produce separate stripes and they have ALL the matching antisera to prepare a colloidal gold label matching the different antigen stripes. It is the same situation as for the variants of the HIV test they have approved. What happened in West Africa was a mutation/amplification of the virus because it infected so many people that the Ebola outbreak was difficult to contain. But now they have all the sera from the different people infected and Chembio needs to access all that sera to make sure they are able to detect the different strains of virus.

    OR, they need to hook up with any group working on a vaccination that produces strain cross reacting antibodies to provide prophylactic and/or therapeutic immunizations. Look to the DARFA initiative to follow those collaborations.

    But yes . . . if Chembio pins this one down, it will be a big pop.

    GLTAL

    Sentiment: Buy

  • rehdvm2004 by rehdvm2004 Jul 15, 2015 9:13 AM Flag

    I logged onto Yahoo and checked out Inovio where there are no messages that I can read . . . bashers, day traders and idiots all in high activity mode.

    But the Yahoo headline about Pfizer shows Inovio's plans are correct in focusing on immunotherapy for cancer . . . and

    The PD-1, PD-L2 patent naming the other companies preparations shows a unique understanding of patent law. Patent law, is a legal hypothesis, predicated on scientific facts. The claims are the hypotheses. What Inovio is claiming is that any antibodies or ligands that they produce will have so many similarities to other PD-1, PD-L2 preparations that they could literally be equivalent. The is the antithesis of the patent positions taken by Integrated Genetics and Amgen back in the early 1980 where a dispute occurred over the different recombinant protein configurations. IG was clobbering Amgen until Amgen proved that their erythropoietin was as similar to naturally occurring erythropoietin as IGs preparation. Remember PD-1 and PD-L2 are naturally occurring agents in the mammalian body. All a preparation of either provides through therapy is an excess of the molecule that damages the cancer cells by causing them to become immune sensitive.

    It is a smart move to have overlapping claims with existing novel substances compared to natures own.

    GLTAL

    Sentiment: Strong Buy

  • "Trial watch: Naked and vectored DNA-based anticancer vaccines"

    Discussion published on April 2, 2015 gives a comparative overview of progress in cancer vaccines.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Insider trading alive and well

    by markets_r_rigged Jun 9, 2015 12:52 PM
    rehdvm2004 rehdvm2004 Jul 3, 2015 7:25 AM Flag

    Grifols, a multi $billion Spanish company, has their world wide (other than US) marketing rights remuneration to ARDM set up in regulatory milestones. The total package is more than $80 million. ARDM has 16 employees who are all upper management types who control the IP and licensing. In order to start a Phase III, they have to perform all the clinical trials with the same product manufactured by cGMP. So there will be no dilution because this far out Grifols knows what is happening with the clinical sites. This far out ARDM and Grifols are submitting monthly reports to FDA per the clinical trial monitoring site which is verified by the FDA with each submission (most companies do not submit monthly reports . . . probably very smart). And mostly this far out you and other idiots are trying to create increased selling so you can start manipulating the SP. So this far out . . . you are a joke of a day trader.

    GLTAL

    Sentiment: Strong Buy

INSM
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