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OncoSec Medical Incorporated Message Board

rehdvm2004 58 posts  |  Last Activity: May 19, 2016 9:42 AM Member since: Oct 21, 2004
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  • 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

  • 1. The regulatory process takes years and most investors do not understand that fact of life. I buy into biopharma or new enterprise because of DD on the technology and whether the product line can be projected a major milestone in 3 years. Inovio as unique technology EP and now will expand into pneumatic. The circular constructs are also unique to the point that each is automatically patentable upon design. Throw in the IL-12 stimulants to T-cells Inovio has a "boundless future."

    2. Because of 1 (above) the investor has to buy, hold and/or accumulate for years. Best just to buy, toss the shares in the safe deposit and look every 6 months. If the DD from 1 (above was promising within the normal script for developing a biologic).

    3. If you read "Rising Sun" the Michael Chriton (sp?) book, there is a very interesting chapter in which Connor explains to his underling that the Eastern Culture has one distinct advantage . . . they plan long term. He went on to say that some Eastern companies have 20 and 100 year plans. Western Culture is more short sighted and barely plans beyond a year (except for Jack Welsh and GE). So it is easy to get people to emotionally react and second guess their own DD. That is where the "shorties" and day traders come in. They do a "Chicken Little" . . . "the sky is falling routine" and get some slack in the system. Actually it is not the jokers on this MB or other MB, it is the MMs who are moving large blocks of stock. The "joker posters" are just a side representation of selling off 100,000 shares by a group that has that much to sell.

    So the moral of this story is . . . buy Inovio because of what you expect to read 3 years from now. I bought 10,000 shares in March of 2013, took the RS and built back to 8,530 shares. Holding and watching the next three years of milestone get reported . . . one by one . . . waiting patiently for 3-5 months per milestone.

    I have $40,000 plus invested . . . so judge 4 yourself.

    GLTAL

    Sentiment: Strong Buy

  • Checked PubMed (Medline Library of Congress) and the scientific/technical staff of ARDM had a scientific article published in March 2016 on how the two drugs work in vivo. The article is:

    Pharmaceutics. 2016 Mar 1;8(1). pii: E6. doi: 10.3390/pharmaceutics8010006.

    Development of Liposomal Ciprofloxacin to Treat Lung Infections.

    Cipolla D1, Blanchard J2, Gonda I3.

    The authors are all identified as employees of ARDM.

    In checking out the journal, it is published twice per year in China (pending a June issue 2016). The other articles in the March 2016 journal were not shabby, but not earthshaking either.

    The important point of the article is that is shows the beneficial effect of the liposome in penetrating the biofilm and accumulating in the fixed macrophages. The article also indicates several future directions for using the liposome for antibiotic delivery (antibacterial and antifungal). The technology parallels other inhalational antibiotic companies (most big, some midcap) that are on the same course. The fact that ARDM chose to encapsulate Ciprofloxicin is the important fact. One of the safest and broadest spectrum antibiotics.

    GLTAL

    Strong buy and accumulate

    Sentiment: Strong Buy

  • Reply to

    Five year bet by a hedge fund . . .

    by rehdvm2004 Apr 29, 2016 10:05 AM
    rehdvm2004 rehdvm2004 May 13, 2016 12:39 PM Flag

    The European physicians who participated in the Phase III and ARDM scientists just "trampled" the tramp. What idiot would wait until the last patient came off the follow-up monitoring phase to unblind the data from the first 50 enrollees who came off the study more than a year before? Interim data analysis is done all the time (not by robots who wait for one date to start processing) but by the physician participants who exist in a "publish or parish" environment, or by ARDM management itself. The collation of all data into the NDA submission has to wait for the checkered flag on the clinical trial, but not interim assessment. BTW . . . how does the MB Robot think that decisions are made to "discontinue" or "terminate" clinical trials? These decisions are made based upon the careful analysis of interim data. This idiot can argue all he wants, but the process allows Sponsors to follow interim data and be ensured of outcomes. The Phase IIb data had the kill rate for Pseudomonas aeroginosa at between three and four logs of kill. For those of you who do not know or work with that outcome . . . that means that if a patient had 1000 bacteria per milliliter of sputum, they would have less than 1 vegetative (capable of reproducing itself) bacteria on a quantitative pour plate culture. 1000 goes to 0. That is three logs of kill. Four means 10,000 to 0.

    Time to relapse is also important because it indicates the carryover kill capability of the Cipro.

    GLTAL

    Ignore all tramps

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 May 13, 2016 9:54 AM Flag

    The low volume keeps out pests. No play with 12,000 plus average daily volume unless it was swinging several $$ per day. This is a one horse show with steady progress since the Phase III was initiated. If the poster that is coming up at Thoracic Society shows the same rate of Pseudomonas "kill" as the Phase IIb, the outcome is very clear and the time spent "holding" and "accumulating" this stock will be realized. If the secondary outcomes of prolonged time to any exacerbation of Pseudomonas reinfection is also achieved (that would be due to protracted antibiotic effect in the fixed macrophages of the lung) then it is a double win. We have to wait and see. September will be a showcase month for ARDM. If the data, which is probably being unblinded for early enrollees as we speak, starts to show statistical significance, Grifols will come up with some of the payments that were contingent on achieving regulatory milestones. One of the first signs from ARDM will be on the "Careers" part of their website. Right now they are only looking for "consultant" positions because Grifols is probably lending expertise on production, clinical trials and regulatory submissions. But ARDM will have more clinical trial candidates based upon the inhalational liposome. For example, the lungs have their own immune system, so vaccination of the lungs for allergens and pulmonary active drugs would be potential developmental opportunities. If they could have a slow release asthma drug for instance, that would be an important addition.

    Anyway, it was a long watch, but the end is in sight. Watch for the therapeutic conclusions from the Pseudomonas paper. P aeroginosa is a ubiquitous opportunistic pathogen because it is in all the water around us.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Longs Need to Calm Down

    by awalkinthejungle May 11, 2016 8:24 PM
    rehdvm2004 rehdvm2004 May 12, 2016 9:45 AM Flag

    If you cannot wait for the regulatory process to play out . . . do not invest in biotech, biopharma or the like. It takes years to get to regulatory approval. But the MMs play with "the lack of PR" and cause those who do not understand to try to play with them. The only losers are the retail investors who do not understand. Best advice for biotech, biopharma . . . choose companies with breakthrough technology . . . buy on a down turn and monitor for three years and ride out the ups and downs. If you do good DD and look for publications about the technology on Medline and specialty medical groups, you seldom go wrong But even good ideas can tank. Look a the whole blood substitute sector and Biopure as an example. By not excluding a specific type of enrollee to an elective surgery protocol . . . they got two more heart attack deaths than the group that got blood transfusions. Do not allow smokers in your protocols.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    New investor in INO here's some good advice

    by tjbrowndiver May 11, 2016 4:16 AM
    rehdvm2004 rehdvm2004 May 11, 2016 2:40 PM Flag

    Simple way to eliminate bashers and day traders . . . graded profits percentage. Hold for a year or more (15% tax), 6 months to 12 months (20%), more than 3 months, but less than 6 months (25%) and less than 3 months (30%). So day traders would end up working for the government and the IRS. EOS for day traders, MMs and jerks.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 May 11, 2016 1:45 PM Flag

    The other valuable part of an SID (single dose per day) antibiotic is that if you miss the time or even a day . . . you still achieve the desired effect of killing the bacteria. The antibiotic collects in the lung in the "fixed macrophages" which, coincidentally, is where the bacteria (particularly NTM) collect.

    GLTAL

    Wait for the results this Fall and the SP should start to build towards a rewarding investment.

    Sentiment: Strong Buy

  • Reply to

    Five year bet by a hedge fund . . .

    by rehdvm2004 Apr 29, 2016 10:05 AM
    rehdvm2004 rehdvm2004 May 11, 2016 1:41 PM Flag

    So as I suggested, but was corrected by an idiot, some of the data from the Phase III was rounded into suitable shape for a presentation by some Europeans and is going to be presented as an abstract or poster at ATS. That is one of the pulmonary societies where highly credible scientific/clinical info is presented. But not only is the data from the clinical trial worthy of presentation by this prestigious society, but the Oregon State Medical School preclinical data on NTM is also being presented. These two areas of product development have the capability of becoming (additive) a $1 Billion market in the next 3-5 years. When a company hits $1 Billion in sales . . . they become self sustaining per the book on company development that was published back in the 1970s. In essence a small company doing good business develops steadily until they reach $3-5 million, then they organize into departments. After this they destabilize until they reach about $100 million and their departments re-stabilize. Then they grow until they diversify into subsidiaries (somewhere around $300 million) and they destabilize again. When the dust settles following formation subsidiaries and the corporation reaches $1 Billion . . . they go on into the sunset doing whatever business. Now that was written in the 1970s when there were a handful of $1 Billion companies. According to the book, DuPont was the largest at the time. But the point is that ARDM has a clear path to two valuable preventive/therapeutic prescriptions for liposome Cipro.

    Several years ago, when I first invested in ARDM, I brought up the simple point that fluoroquinolones are among the safest broad spectrum antibiotics (Ciprofloxicin for humans and Baytril for veterinary medicine). If a person or a dog gets a lung infection . . . the prescription would be 7-10 days of oral pills and simultaneous inhalation of lipid Cipro. Still the safest and most efficacious treatment schedule going.

    GLTAL

    Sentiment: Strong Buy

  • be a drug of choice for pulmonary infections (preventive and therapeutic) long after the nay sayers have gone the way of the Dodo bird.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Five year bet by a hedge fund . . .

    by rehdvm2004 Apr 29, 2016 10:05 AM
    rehdvm2004 rehdvm2004 May 8, 2016 8:30 AM Flag

    What does work is . . .

    With a patient enrollment of 255, begin un-blinding the first fifty clinically enrolled patients when they complete the follow-up clinical monitoring. Analyze that data and draft the outline of the report. Most importantly, you analyze the data to verify that the results are tracking in the same manner (similar safety and efficacy) as the Phase IIb. If that is on track, you proceed with the next 50, the next 50 in the same manner to build to the ultimate conclusions and claims that will result in the label copy for the drug. The point is that you analyze the data in parallel with writing the NDA. Not in series. The regulatory pathway is too long to use that writing and submission model.

    But importantly, in the sequential write-up for incremental groups of 50 patients . . . a clear pattern of safety and efficacy becomes apparent . . . AND much of these data come from one or two clinical sites . . . they can write and abstract for a poster at a scientific meeting.

    Having been a "ghost writer" for many physicians who were medical directors for clinical trials, I have written lots of sections of INDs, NDAs, BLAs and environmental impact statements. It is just following a form and answering questions. Always took months, but there were ways of getting data out before the public . . . without breaching the confidentiality for the clinical trial to the FDA, EMEA, or other regulatory agency. You just have to know the process and where the openings occur.

    You (td) obviously do not because you quote regs like a clock (robot?) versus working with the system but also giving the company info to achieve milestones and grow a product line.

    GLTAL

    Down with robotic naysayers

    Sentiment: Strong Buy

  • Reply to

    Five year bet by a hedge fund . . .

    by rehdvm2004 Apr 29, 2016 10:05 AM
    rehdvm2004 rehdvm2004 May 6, 2016 10:21 AM Flag

    Actually, the September milestone was "rough calculated" based upon 30 days projected, not 28. But the comment also said that a poster session and/or scientific article could be scheduled for presentation around the same time. So it is speculation of course. But mine is based upon43 years of working with physicians to get IND, BLA and other regulatory documents filed. Yours is based upon day trading, bias and emotional dislike of people who write general information about what is going on. So you should be running for the vice presidential position. You would fit right in. No discussion, just disagreement. ESAD.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Five year bet by a hedge fund . . .

    by rehdvm2004 Apr 29, 2016 10:05 AM
    rehdvm2004 rehdvm2004 May 3, 2016 4:12 PM Flag

    It is like beating up a "straw man" and finalizing the insult with a match!

    Rationale:

    1. The paperwork was submitted to the SEC.

    2. The note does NOT mature for five years.

    3. Sometime around September of 2016, the top line data will become known. What clinical milestones does the average . . . generally informed ARDM retail investor believe will be the target date for some type of positive clinical data.

    4. The $$$ COULD be used to jump start the NTM studies that will be needed prior to the top line data getting all or part of the $65 million from Grifols for the bronchiectasis data.

    5. Cipro is the only inhalational antibiotic that can be given orally . . . simultaneously without significant side effects. Fluoroquinolones are among the most safe and efficacious antibiotics used in either human or veterinary medicine.

    6. The FDA just approved inhalational Cipro solution for anthrax. Imagine that ARDM will dove tail its use of liposome Cipro on top of that application.

    7. The reason Grifols invested was because the ARDM preparations showed 3-4 logs of kill of Pseudomonas aeruginosa KILL for the treatment regimen in the Phase IIb study.

    I am tired of knocking down "nay saying day traders." I am in Costa Rica on Tamarindo Beach. Sell your shares and get lost.

    GLTAL

    Sentiment: Strong Buy

  • First Eagle is making a 5 year bet. But what is the objective?

    I think it is to get into NTM FAST! This is a disease that only has multiple modality treatments (like cancer chemo) to cure. This is due to the resistant cell wall of the Mycobacteria.

    GLTAL

    Sentiment: Strong Buy

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