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Insmed Incorporated Message Board

rehdvm2004 125 posts  |  Last Activity: 7 hours ago Member since: Oct 21, 2004
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  • rehdvm2004 rehdvm2004 7 hours ago Flag

    Oh, I forgot to state the reason. Bankruptcy is a specific Federal filing. Not a speculative interpretation of some FDA filing, interpretation, or other. It requires a specific form and a specific filing. Stock manipulators cannot make that claim if it is untrue. Bozo forarmy1 stated he/she "read about ONCS filing BK (abbreviation for 'bankruptcy') papers out there." That is a specific statement that recites a "fact." If not substantiated, it is over the line for fraudulent claims. BTW, because BK papers are a specific entity, it cannot be claimed that is was permissible to pass it from another MB or blog. So long idiot.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 8 hours ago Flag

    Go to secDOTgov and look for the complaint form. If this is untrue, you can get rid of this basher once and for all. Making a false statement about bankrupsy, even on a MB is considered an offense.

    ONCS has two years of work to go, but false statements are not part of this pathway.

    forarmy1 can ESAD!

    GLTAL

  • Reply to

    Ebola not contained

    by sonomaca Nov 22, 2014 10:43 AM
    rehdvm2004 rehdvm2004 10 hours ago Flag

    The virus mutates when it infects a host and changes its epitopes (outer surface markers) or method of causing pathogenicity. It takes passage through humans to change its infectivity for humans. People who survive are immune for life (that is the current believe) and cannot shed virus irrespective of what strain it represents. There have been no studies thus far to say that the neutralizing antibody from one strain of Ebola is ineffective against another. There is only so many changes that are brought about by one mutation. The number of Ebola cases is going down and transmission is going down. That is what they have to achieve to contain the epidemic. If what you say is true, then Chembios only hope for a DPP test is to lay their hands on as many different Ebola strains as there are isolated. Not a recombinant protein form one source. That would represent an Ebola test for only that strain of virus. That is how it works. That is why there are 5-7 different lines on the HIV test. Each strain of HIV has different epitopes that allow detection.

    Sentiment: Buy

  • rehdvm2004 rehdvm2004 13 hours ago Flag

    The amount of data that has to be supplied in the NDA alone is a trilogy times three. That is not even including actual patient summary reports. One for each person treated. The focus there becomes "non-responders" and "serious side effect patients." But the process is cumbersome and fraught with pitfalls. The regulatory people reserve the "first right of refusal" on any segment of an NDA. When they ask a question, it starts a 90 day clock for a response. Usually there are many questions, that lead to other questions, that lead to other questions. Anti-cancer drugs used to take the longest and cost the most $$$. Now it is everything. But the good news is that vaccine studies are usually less expensive. Because there is a high correlation that if you can get a high neutralizing antibody response in mice, you can usually do the same in humans or other mammalian species. The release test for most vaccines is performed in challenged mice about 99% of the time. I cannot think of one that is not, but there must be one somewhere. That comes from being the veterinarian for the State Biological Laboratory in MA (they make DPT, the first respiratory syncytial virus vaccine and others) and CRL which did developmental tests for many experimental and approved vaccines.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Ebola not contained

    by sonomaca Nov 22, 2014 10:43 AM
    rehdvm2004 rehdvm2004 Nov 22, 2014 10:50 AM Flag

    The whole continent of Africa is now on alert and preparing for intrusions. Some more people may die (unfortunately) but the ability to have thousands get exposed with no controls is abated. This disease is largely controlled by containment, which is personnel protection equipment (PPE) and supportive therapy. If they had PPE during the Black Death period and knew the cause, they would have had far fewer deaths. Of course Black Death was spread by rats and their fleas, not people, until it became Bubonic and could be spread by a cough.

    Sentiment: Buy

  • Reply to

    rehdvm

    by sonomaca Nov 11, 2014 10:10 AM
    rehdvm2004 rehdvm2004 Nov 22, 2014 10:46 AM Flag

    The problem is that either a number needs to be generated (by a reader) or the test needs to be preserved (archived) for validation. That is the way diagnostic medicine is performed. Throwing it in bleach, alcohol takes a long time to inactivate viruses, or other destroys the test device. The goal is to disinfect the test while not destroying the ability to read, record or photograph. If you have ever worked in a diagnostic laboratory (I did for 2.5 years working my way through veterinary school) you learn how to certify test results. In medicine, uncertified test results end up in lawsuits. There are about 2% poor tests performed because of technician error, machine error or contaminated samples. The DPP is a breakthrough because of its sensitivity. We did comparative tests with Luminex and DPP was readable when Luminex was a repeat test.

    GLTAL

    Sentiment: Buy

  • Reply to

    record high basher possts on one m.b.

    by originalbrowntown Nov 22, 2014 3:22 AM
    rehdvm2004 rehdvm2004 Nov 22, 2014 9:39 AM Flag

    Until Inovio announces the start of a Phase III, they are going to be a punching bag for manipulators. ONCS also, but there is not fifty cents of drift per day to squabble over on this stock. Wait until ONCS announces their next milestone and get to $1. Then the bashers will start fighting over 20 cents. If the number of shares traded each day gets up into the millions, that is where the bozos will begin the daily bash parade.

    GLTAL

    Sentiment: Strong Buy

  • ONCS is on the cusp of a Phase III and Inovio has preclinical safety and efficacy results. So comparatively, the ONCS group has a lead to get through the regulatory maze first with a first generation vaccine. When they do anything differently from what has lead them to the Phase III threshold, other than modify the number of, volume or total amount of vaccine, they go back to square one. The probable exception to this is whether they change electroporetic methods. This is simply a form of injection and there are now many devices for electroporetic injection that are marketed. Probably a change that the FDA would not want tested heavily. But if ONCS adds a molecule, substantially changes the formulation, etc. They have to repeat a Phase I, Phase IIa, Phase IIb clinical trial pathway. They would be wise to partner up for this first generation Melanoma Vaccine and get to Phase III.

    Inovio would do best to focus on Herpes, Hep B, Hep C (huge in my book) and (possibly) Ebola. Too many diseases out there that need vaccines, not enough $$$ to go head to head on every disease.

    GLTAL

    Sentiment: Strong Buy

  • Any moniker posting more than 5 times per rotation of 20 posts is spamming. But you have to take them off "ignore." I just ignore and follow through.

    Sentiment: Strong Buy

  • Reply to

    Facts about Inovio . . .

    by rehdvm2004 Nov 20, 2014 6:08 PM
    rehdvm2004 rehdvm2004 Nov 20, 2014 6:10 PM Flag

    Right now 85% of the posts are on my ignore list. That is about par for stocks that are being manipulated heavily.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Nov 20, 2014 6:08 PM Flag

    They have a tremendous "early" and "mid-stage" pipeline. They have to complete at least one Phase III study to get a revenue stream. They will not be the vaccine manufacturer (for many years) because that resource is a huge investment of space, equipment, testing resources, etc. Not in their "wheelhouse" right now. But the potential is there to develop many novel proprietary vaccines that could be breakthrough. Inovio has elected to focus on cancer and infectious diseases. With a little prioritizing and focus on research, the individual vaccine products will start to become strongly in focus. Just a matter of time. Accumulate slowly while the potential becomes reality. Ignore pumpers and bashers because they are just playing games.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    VGX3100 Study Question?

    by rollapair306 Nov 18, 2014 9:05 PM
    rehdvm2004 rehdvm2004 Nov 19, 2014 9:03 AM Flag

    The actual name of the guidelines are "Target Animal Safety for Veterinary Pharmaceutical Products." Since the target animal is a species that will ultimately be the clinical species, this format for safety testing leads to very abbreviated clinical trials of animals with conditions and then the NADA (New Animal Drug Application) issues.

    Sentiment: Strong Buy

  • Reply to

    VGX3100 Study Question?

    by rollapair306 Nov 18, 2014 9:05 PM
    rehdvm2004 rehdvm2004 Nov 19, 2014 8:57 AM Flag

    The FDA can only approve an endpoint proposed by a Sponsor. They cannot dictate a protocol. The way protocols are developed is to look through FOI (Freedom of Information) at past files for vaccines and duplicate what that Sponsor did to get approved. The only agency within the FDA that does have specific protocols is the CVM (Center For Veterinary Medicine). They published the "Target Animal Species" protocols back in the 1980s.

    The endpoint for a vaccine study include, but are not limited to:

    1. No detectable circulating infectious agent.

    2. Remission, regression or cure of an infectious agent lesion.

    3. And other specific types of measures. In the case of a herpes lesion of the cervix, it might be absence of stain uptake by the mucosal cells, which was always a precursor to biopsies for certain women.

    But the FDA cannot dictate endpoints, only agree with what the Sponsor proposes. Know why? If the FDA dictated the endpoint, they would be legally liable in any lawsuit.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    VGX3100 Study Question?

    by rollapair306 Nov 18, 2014 9:05 PM
    rehdvm2004 rehdvm2004 Nov 19, 2014 7:57 AM Flag

    The experimental design for a Phase IIa, Phase IIb study is pretty straight forward. There is a group of patients (with disease) that get multiple doses of Control Article and a group, or groups that get "escalating doses" of the Test Article. In the case of a vaccine, the escalating doses can be multiples of a set dose, or increasing doses. The Phase IIa must show safety with the highest escalated dose to be used in the Phase IIb (Phase III enabling phase of the study). In a Phase IIb, all the Control doses are the same in volume and number and they compare in volume and number with the Test Article doses. But the results or endpoints in a Phase IIb are compared for efficacy as well as safety. The comparison of endpoints is the number of beneficial results from vaccination compared to the Control which would only include natural regression of HPV in this study. But any demonstration of general safety and multiple standard deviations separation of the Test and Control groups would be favorable for a Phase III clinical trial. But the data would have to be analyzed very closely because in a Phase III, the volume and amount of dose cannot be changed and the number of doses cannot be changed.

    Now for the variables in a vaccine study. The immune system and the ability to respond to a vaccine is variable among all patients. Some of these patients have also taken antivirals drugs in that past, home remedies, have had acupuncture, who knows what!?! Human patients are notorious for not giving accurate clinical history and for telling doctors what they think the doctor wants to hear. So some of the patients admitted to studies are not "naïve" and have been treated before. But Sponsors make mistakes also. They allow patients to enroll who should not be enrolled. The famous VEGF study at St. Elizabeths MC is an example. VEGF in the coronary artery can make the vessel heal faster. But when it passes through the heart and hits an undiagnosed lung cancer . . .

    Sentiment: Strong Buy

  • #$%$nd #$%$void it #$%$t #$%$ll cost! The re#$%$son th#$%$t Roche dropped this project #$%$nd Inovio will not pick it up is over #$%$t clinic#$%$l tri#$%$ls DOT gov . . . 134 v#$%$ccine clinic#$%$l tri#$%$ls for v#$%$ccines in prost#$%$te ther#$%$py. The f#$%$ct th#$%$t PSA st#$%$nds for Prost#$%$te Specific Antibody h#$%$s esc#$%$ped no scientist with #$%$ br#$%$in since the development of the di#$%$gnostic test 30 ye#$%$rs #$%$go. If prost#$%$te cells get exposed to the blood stre#$%$m, they produce #$%$ntibodies. But jumping into #$%$n intense mix of 134 studies #$%$lre#$%$dy registered by the FDA #$%$s h#$%$ving #$%$ clinic#$%$l tri#$%$l underw#$%$y is spending good money for #$%$ ther#$%$py th#$%$t is #$%$lre#$%$dy:

    1. Further #$%$long th#$%$n you #$%$re; #$%$nd
    2. Prob#$%$bly in direct competition with big bioph#$%$rm#$%$.

    Inovio needs to "focus power" like Mr. Mi#$%$gy told D#$%$niels#$%$n.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Nov 18, 2014 12:19 PM Flag

    Increlex is marketed by Ipsen . . . so blame Roche for INSM disinterest in marketing Iplex. Lonza just came back online and has supplied 3 batches released by the FDA.

    Some things never change.

    The SA article is spot on . . . the liposome is the key to INSM future. Many drugs, biological and diagnostic agents can be put into the biofilm compatible liposome. NTM will be a bell ringer, CF/Pa will be in the mix and new drug formulations in the liposome will lead the 10 year development plan.

    Sentiment: Buy

  • Reply to

    Immunotherapy for prostate cancer . . .

    by rehdvm2004 Nov 17, 2014 7:06 PM
    rehdvm2004 rehdvm2004 Nov 18, 2014 5:54 AM Flag

    The important messages are:

    Most prostate cancers are cured by surgery at the in situ (site of origin) after early detection.

    When the PSA goes to 0.0 after the surgery, all risk is ended.

    When the PSA stays below 0.0 for two years it is considered non-metastatic.

    Immunotherapy would only be useful for patients who ignored the risk and got into trouble when they were pretty old.

    I do not think that Inovio is going to put any $$$ into development of this form of immunotherapy.

    Remember Inovio has the whole world of immune cause or immune modulated medical therapies to choose from. They cannot develop them all.

    But the Hepatitis B project with Roche has a huge potential. Hep B is one of the fastest spreading infectious diseases in humans.

    GLTAL

    Sentiment: Strong Buy

  • This form of immunotherapy would be used for men who ignore prostate screening and health after they are 55 years old. Prostate disease is a form of tumor and metastatic cancer for men who do not have PSA screening and the "finger check." I am speaking from the vantage point of being an advocate for family and friends who have had benign prostate hypertrophy (Father and Uncle), prostate tumors with more that 5 of 12-14 biopsies that are grade 2-5 and more than 20 years experience with these men. I have known two men who had metastatic prostate cancer (one 56 years old and one 76 nears old) who passed in the early to mid-1980s. Another was an 80 plus year old who had one of the first Cesium needles procedures, also in the 1980s. Every single one of the patients in the 1990s forward is alive and well today because of early detection, timed following of PSA, multiple biopsies and surgery. One guy in his 80s had hormones and Cesium needle implants about 5 years ago and he is doing fine. His PSA is less than 1.0, down from 12 plus.

    The "cure for prostate disease" is surgery. Two close friends had the "unzipping" surgery which was wholesale traumatic and slow recovery. They do this technique if there are attachments or possible involvement of other organs. But prostate surgery has evolved to two types of "minimally invasive surgery" - laparoscopic and robotic surgeries which is a form of laparoscopic surgery. Using minimally invasive surgery, surgeons can remove the prostate in sections, preserve the pudendal nerves and perform this all through three or four 3/4 inch incisions. Preserving the pudendal nerves is a big issue for "maleness" and bladder control. One friend of mine was up and about in 2 days with minimal discomfort. He had two weeks of incontinence because the pudendal nerve was swollen and had interrupted transmission. But that went away with time and less inflammatory response.

    But this disease is treated best by surgery. Do your own DD.

    Sentiment: Strong Buy

  • When I used to do the Introductory Veterinary Medicine course at Tufts (now Cummings School of Veterinary Medicine) I had W. Jean Dodds each year. She was a role model for women and veterinarians in general, but she was so down to Earth practical and sensible. The vet students were all high minded about "mice being used in research" so Jean would ask them two questions. "If you suffered from a disease that would wreck the quality of your life (not kill you, but just damage your quality of life) . . . how many of you would allow a drug to be used on you that had never been tested for safety in an animals model?" We had 65 students and about 10-12 hands would go up. Jean would look down, smile and then ask . . . "How many of you would allow that same drug to be used on your child?" All the hands disappeared. So the mouse is important to preclinical demonstration of safety. The release test for each batch of vaccine is a mouse test, BTW. Not that any stock broker, day trader, MM wanabee would know or admit to that. So Longs should just ignore the BS and stay tuned. I have been watching Dr. Kim's presentations and there is a lot of good science and good medical practice in Inovio. Let's see where these bozo bashers are in 2016. They are going to be attempting to short some other start-up biopharma with good results by suggesting "the ship is sinking!?!" Only because they have such "short" term understanding and goals for investing that the ship sinks when they pull the drain plug and they are left with no water in the tub, not ducky and holding their . . . (choose the word) . . .

    GLTAL

    PS - it is easy to make hash out of these bozos and I have all the bashers and several pumpers on iggy!

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Nov 13, 2014 8:27 AM Flag

    No problem. You had not asked before. Thoughts:

    This is a fairly "long termer" (probably 2-5 years) depending upon which pipeline product. In terms of DD, they are working with Dana Farber on cancer which is thorough DD in itself. DFCI is in the forefront of finding new and better agents for clinical trials. I worked with Dr. Bev Teicher for years on various multiple modality combinations in laboratory mice. The other aspect of CTIX is they are diversified. The preclinical safety and probably efficacy stuff for the oral mucosa is probably a hamster cheek pouch model of tumor implant, treatment and irradiation. I have not worked with this model very much, but I know about it because of a consulting arrangement I have.

    Looks like a good long term investment that needs to be monitored monthly. I do not know what their regulatory milestones are, but if those pipeline goals look sound and they hit the scheduled marks, they should leave their mark in several areas of therapy.

    I think they would be a buy at this time.

    GLTAL on ARDM

    Sentiment: Strong Buy

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