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OncoGenex Pharmaceuticals, Inc. Message Board

biotechinvest1077 148 posts  |  Last Activity: Feb 4, 2016 12:23 PM Member since: May 27, 2008
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  • Reply to

    Another one published today

    by rodsauve Feb 4, 2016 10:44 AM
    biotechinvest1077 biotechinvest1077 Feb 4, 2016 12:23 PM Flag

    End2War,

    You said, "They have not announced one single cancer drug candidate and I hope they stay the hell away from cancer until they have picked off some of the easier RNAi targets where it can be seen more clearly that knocking down a gene will have a clinical benefit. Viruses and genetic defects are just fine for now.Cancer is ten times more complex and difficult to handle, and it costs 10 times more money to work on than AAT or even cHBV. Beware the fight against cancer before ARWR has a $1 to $2 billion warchest."

    I agree with 100%. Great post. Maybe your best. Too much is being read into ARWR's RCC poster in terms of predicting future success based on mouse models.

  • biotechinvest1077 biotechinvest1077 Jan 29, 2016 12:17 AM Flag

    1. Blum said to expect $50 mil. in milestone payments from both AMGN & Astellas (i.e., $50 mil. in total).

    2. Blum also said that CYTK has the right co-promote Omecamtiv in North America by using a portion of the expected milestone payment it will receive from AMGN He said to expect CYTK to exercise that option. (About the 10 min mark)

    The above was stated during the Dec 1, 2015 Jefferies presentation.

    Sentiment: Buy

  • biotechinvest1077 biotechinvest1077 Jan 22, 2016 11:20 AM Flag

    Dothemu,

    Your example of Gleevec, by your own description, is not an apples to apples comparison. Please see my post to End2War for a fuller discussion of why your example is not analogous to ARC-520 in terms of meeting the criteria for early approval.

  • biotechinvest1077 biotechinvest1077 Jan 22, 2016 11:04 AM Flag

    End,

    Let's turn to your statement, "If breakthrough therapy designation is granted, the FDA has been known to grant marketing approval with as few as 111 patients receiving Phase 2 treatment (subject to larger confirmatory study)."

    IMO, this is where you need to compare apples to apples. If you really want to make the case that ARC-520 has a reasonable chance of being approved on "strong Phase 2 data," you need to point to an analogous case. To me, the burden is on you to point to a specific case where the FDA granted early approval (before Phase 3):

    1. The underlying condition is a chronic disease that is relatively well controlled by existing therapy (at least well enough controlled that we can afford to wait for full Phase 3 results). This factor speaks to the notion that a medication might be more easily approved if there is an absence of viable options for the patient. Obviously, the FDA must balance the risk of depriving the patient of the new medication against the risk of harm of approving same before adequate Phase 3 data is available. If the patient will die without the new medication, the balance tips strongly in favor of early approval. If a reasonable alternative is available, the balance tips strongly against early approval; and.

    2. For a medication or class of medications having no prior approvals. Since DPCs have no prior track record of safety, the FDA will be especially cautious in approving same without Phase 3 data in hand.

    If you have examples comparing apples to apples, I would be more than happy to concede the point.

  • biotechinvest1077 biotechinvest1077 Jan 21, 2016 10:28 PM Flag

    There was more to the above post but Yahoo is preventing me from posting.

  • biotechinvest1077 biotechinvest1077 Jan 21, 2016 9:31 PM Flag

    End2War,

    We are not simply talking about Breakthrough Therapy Designation. Holden made the following statement:

    "(GILD) Pharmasset still collecting data in its P3 trial. They received marketing labeling approval after P2. For an unmet medical need with a statistically robust P2 data set don't need P3. ARWR currently enrolling and treating or have treated 350 patients. That number will increase as P2 progresses and is more than enough to secure an FDA labeling approval. Can start marketing with stated commitment to conduct post-marketing P3 as the drug rolls out...."

    In fact, GILD's Solvadi was approved after four (4) Phase 3 trials. Yet somehow no one else noticed this rather significant factual error supporting his basic premise.

  • biotechinvest1077 biotechinvest1077 Jan 21, 2016 4:04 PM Flag

    Holden,

    You wrote, "(GILD) Pharmasset still collecting data in its P3 trial. They received marketing labeling approval after P2. For an unmet medical need with a statistically robust P2 data set don't need P3. ARWR currently enrolling and treating or have treated 350 patients. That number will increase as P2 progresses and is more than enough to secure an FDA labeling approval. Can start marketing with stated commitment to conduct post-marketing P3 as the drug rolls out...."

    Where did you get the idea that GILD's Solvadi was approved without Phase 3 data? In fact, Solvadi was approved after four (4) Phase 3 trials.

  • biotechinvest1077 biotechinvest1077 Jan 21, 2016 12:23 PM Flag

    Holden,

    Aren't the complications you are talking about the result of liver damage that occurs over years after initial HBV infection? If this is the case, how would ARC-520 help any of those patients? IOW, if you give ARC-520 to HBV patients who have long been infected and now have life threatening complications, the underlying HBV disease has already done its damage. Curing the disease with ARC-520 at this point is not going to save the patient. Don't you have to reach the patient with ARC-520 before the disease has done its damage?

  • biotechinvest1077 biotechinvest1077 Jan 21, 2016 11:46 AM Flag

    Hparch,

    You certainly gave me the impression you supported Holden's "forecast" regarding the chance of early approval following strong Phase 2 data. Glad to read that you believe this possibility to be "very, very remote."

  • biotechinvest1077 by biotechinvest1077 Jan 21, 2016 10:37 AM Flag

    I am very bullish on ARWR but asserting that ARC-520 will likely be approved on strong Phase 2 data is simply believing in fairies and leprechauns. It is pure fantasy.

    Consider first that HBV is a chronic disease that is essentially controlled with NUCs. It is not life threatening so the FDA is not faced with a dilemma where the patient is going to die if the ARC-520 is not given to the patient. Hence there is no compelling reason to break with long standing procedures that are in place because safety is the highest priority. It is not even a close question.

    If you disagree, please give specific examples where the FDA approved a new type of drug (in this case DPC) for a disease that is merely chronic and for which there are already approved medications that control the disease.

    Honestly, the overreaching that takes place on these message boards is simply astounding. Those who engage in such nonsense lose all credibility.

  • Reply to

    abus trails arwr

    by A Yahoo! User Jan 14, 2016 9:36 AM
    biotechinvest1077 biotechinvest1077 Jan 15, 2016 3:38 PM Flag

    Obwan,

    Whether ABUS's ARB-1467, their compound currently in Phase 2 for HBV, effectively targets iDNA is the 64,000 dollar question. I don't think we know the answer yet. As far as I am aware, ABUS has not even confirmed that they agree with ARWR's hypothesis about HBV iDNA as revealed during their September 2016 Analyst Day, let alone whether ARB-1467 effectively targets HBV iDNA.

    Do you agree with the above? If not, please state what information I have missed.

    Further, based on the above, I interpreted ABUS's recent corporate update announcing their new "significantly more potent" ARB-1740 follow on compound for HBV as indicating that ARB-1467 probably doesn't effectively target HBV iDNA. Of course, this is pure speculation on my part.

    I, for one, would like to get a more definite answer. Any light you (or others) can shed will be greatly appreciated.

    Sentiment: Buy

  • biotechinvest1077 by biotechinvest1077 Jan 10, 2016 5:26 PM Flag

    Arbutus just released a corporate update.

    After stating they expect to have their HBV RNAi candidate - ARB-1670 - Ph2 results for SAD in Q3 and for MAD in Q4, Arbutus's release states:

    "ARB-1740. Arbutus continues to work on developing follow-on RNAi products for HBV. This includes ARB-1740, a product candidate that is significantly more potent than ARB-1467 in preclinical studies and has the potential to be effective at lower clinical doses than the current sub-milligram dose range ARB-1467. ARB-1740 employs the same LNP formulation as ARB-1467 (with a different set of three RNAi triggers). Arbutus expects to file an IND (or equivalent) for ARB-1740 in 2H16."

    Perhaps I am wrong but this is the first I have heard about ARB-1740. I speculate that ARB-1740 "with a different set of three RNAi triggers," is ABUS's answer to ARWR's ARC-521. If correct, this would explain why ABUS has been silent, at least to my knowledge, about whether or not the original triggers used in ARB-1467 effectively target HBV integrated DNA. Why no analyst has asked ABUS whether ARB-1467 effectively reached HBV integrated DNA is inexcusable if true.

  • biotechinvest1077 biotechinvest1077 Jan 8, 2016 12:56 AM Flag

    investron, your post is simply a lie. Here is the context you tried to evade. At least you are consistent.
    ---------

    Reply to Why ARWR by investron •Aug 8, 2013 9:59 PM
    biotechinvest1077 • Aug 23, 2013 4:36 PM

    Investron,

    Would you please cut out the hyperbole. You show your hand as a pumper plain and simple when you post #$%$ like this.

    You think ARWR is undervalued. I do too. And if the science proves itself in clinical tests, I am sure ARWR will go much higher.

    But your linking the superiority of the scientific worldview to the inevitability of an ever higher ARWR stock is disingenuosness.

    By all means, sing the praises of ARWR's technology. Just cut out the breathless pumping.

    ---------------------

    What about the above is so hard for you to comprehend? Now go back and post some more bs that will assuage your bruised and petty ego. And please let us know when that Seeking Alpha article you've been working on for the past few years is ready. You haven't deleted those posts yet have you? They were hysterical. Remember?

  • biotechinvest1077 biotechinvest1077 Jan 5, 2016 4:44 PM Flag

    There you go again, investron.

    You are simply incapable of engaging in civil conversation.

    What evidence do you have that your stock market crystal ball is made of different stuff than the one the next guy is holding? Certainly, your track record as revealed on this board doesn't support any such claim. You always resort to ridicule and insult as a matter of first resort. And your very occasional attempts to offer fundamental arguments are shallow and are easily outdone by others on this board. So what do you really offer readers. Not much besides mean spiritedness and a driving determination to outshout all comers.

    Congratulations. You are hereby awarded the grand prize for mean-spiritedness coupled with a dogged determination to be the last one shouting louder and more obnoxiously than all the rest.

    Again, you say your goal is to "slap the lemmings" upside the head to make them "wake up." But why would anyone want to wake up to the nightmare reality that is investron? You can't even offer them a track record of stock market success yet you berate and lampoon others for their stock market mistakes. And make no mistake. That is all you are doing. You educate no one with your after the fact taunts.

    Can't you ever let others have their say? If you disagree with something someone says, offer a polite but contrary view that indicates respect for the person if not the view expressed. Even better, try a cogent argument that marshals the facts in a way that shows the clear superiority of your view. And if others insist on being a "lemming," you rudely and aggressive hurling that epithet is not for their benefit. It is for your benefit.

  • biotechinvest1077 biotechinvest1077 Jan 5, 2016 4:41 PM Flag

    So what?

    You were pounding the table on ARWR at $27, MRNA at .55+ and urging all to short ALNY at $55. And while you have pointed out when others have gone AWOL after getting things egregiously wrong, you too went AWOL from this board after getting things egregiously wrong. By the standards you impose on others, you are a complete failure who should be ignored. Yet you keep posting here as if you are an Old Testament prophet.

    Simply stated, you love to engage in ad hominem attacks. Why not make the case for ARWR rather than engage in your constant drumbeat of invective pointing with great joy at the wrong stock moves of others? After all, hindsight, especially with regard to the stock market, is always 20/20.

    And again, while you claim your goal is to "slap the lemmings" upside the head in order to wake them up, why do you insist, in the face of all contrary evidence, that your mean spirited approach is the best way to get others to see the light? Why not try cogent and well stated facts and evidence? I think the reason you don't is because you can't and because you are deeply angry and frustrated in the real world and this is your only outlet for expressing your deep-seated anger.

  • Reply to

    end2war - Kept Overanalyzing It

    by investron Jan 5, 2016 9:20 AM
    biotechinvest1077 biotechinvest1077 Jan 5, 2016 1:12 PM Flag

    So what?

    You were pounding the table on ARWR at $27, MRNA at .55+ and urging all to short ALNY at $55. And while you have pointed out when others have gone AWOL after getting things egregiously wrong, you too went AWOL from this board after getting things egregiously wrong. By the standards you impose on others, you are a complete failure who should be ignored. Yet you keep posting here as if you are an Old Testament prophet.

    Simply stated, you love to engage in ad hominem attacks. Why not make the case for ARWR rather than engage in your constant drumbeat of invective pointing with great joy at the wrong stock moves of others? After all, hindsight, especially with regard to the stock market, is always 20/20.

    And again, while you claim your goal is to "slap the lemmings" upside the head in order to wake them up, why do you insist, in the face of all contrary evidence, that your mean spirited approach is the best way to get others to see the light? Why not try cogent and well stated facts and evidence? I think the reason you don't is because you can't and because you are deeply angry and frustrated in the real world and this is your only outlet for expressing your deep-seated anger.

    Sentiment: Buy

  • Reply to

    ARWR moves 2016

    by onlytruthsayer Jan 3, 2016 4:45 PM
    biotechinvest1077 biotechinvest1077 Jan 4, 2016 4:58 PM Flag

    NFR,

    At least in contrast to the constant drumbeat of irrational exuberance expressed by quite a few longs here (and I am long ARWR), I like your skeptical attitude. But in spite of the picture you paint, you said in another post that you bought some shares today. Why buy in the face of the picture you paint? Is this your first purchase? If not, when did you start buying? I assume you believe the risk reward is good or you would remain on the sidelines.

    Sentiment: Buy

  • Reply to

    ARWR moves 2016

    by onlytruthsayer Jan 3, 2016 4:45 PM
    biotechinvest1077 biotechinvest1077 Jan 4, 2016 12:20 PM Flag

    "Their good stuff is sitting on the bench waiting for money."

    Please tell us what you mean. Are you thinking of something specific or just a general sense mgmt is holding back till they have additional funding?

  • biotechinvest1077 biotechinvest1077 Jan 3, 2016 2:05 PM Flag

    HP,

    Regarding the article you reference, it appears to have been commissioned by the Humane Society for the purpose of rolling back medical testing on Chimps. Specifically referencing this paper, The Humane Society claims in part:

    "[M]any scientific problems with the chimpanzee studies including a lack of biological relevance, questions regarding the statistical validity of the studies, and incompleteness in the reporting of methods and experimental data. While many of the published chimpanzee studies, including the recent study mentioned above (published in the Dec. 3 issue of Science Express), claim to produce important results for the treatment of human hepatitis C infections, closer scrutiny reveals the claims are exaggerated.

    "The cost of using chimpanzees in research is enormous — both financially and in terms of chimpanzee suffering," says Andrew Rowan, Ph.D., chief scientific officer for The HSUS. "If you look collectively at their use, as our recent review does, the benefits for human health have been meager at best. For the most part, studies of hepatitis C in chimpanzees, such as the one most recently touted, do little more than confirm what is already suspected from research that does not involve chimpanzee use."

    Experimental hepatitis C vaccines, usually developed and tested using chimpanzees, have been disappointing when tested in human patients, and the results from chimpanzees have not reliably predicted the human clinical experience. Among the many differences between chimpanzees and humans, chimpanzees do not develop active chronic hepatitis, cirrhosis or liver cancer and often spontaneously clear hepatitis C infection."

  • biotechinvest1077 biotechinvest1077 Jan 1, 2016 7:54 PM Flag

    http://www.pharmaceutical-technologyDOTcom/features/featureabivax-a-new-weapon-in-the-fight-against-hepatitis-b-4583663/

    The following are excerpts from the above article:

    "The drug, called ABX203, is being developed by France-based clinical stage biotech company ABIVAX, after being licensed from the Center for Genetic Engineering and Biotechnology (CIGB) in Havana, Cuba, in 2013. It is a therapeutic vaccine designed to produce immune responses in patients with CHB similar to those that occur in patients with a self-resolving acute hepatitis B virus (HBV) infection."
    ---
    "ABX203 has already shown promising results in trials carried out by CIGB in Cuba and Bangladesh, performing significantly better than the immunotherapy currently on the market, pegylated interferon, in a number of ways."
    ---
    "So far, recruitment for the trial, which is expected to take place at 50 different clinics in eight countries in the Asia Pacific region, is going well, according to Ehrlich - largely because of careful and realistic planning. "We're working with one of the best CROs in the Asia Pacific region and we have been very aggressive about the number of sites we will recruit from," he explains. "Because CHB is a very frequent disease, we believe we will be able to recruit all 234 subjects by the end of Q3 of this year [2015], and so far we are essentially on track."

    "Then, if the trial is successful, which should be confirmed by late 2016, ABIVAX will look to get market authorisation in selected countries in Asia, and subsequently bring the drug to Europe. "We would initiate a European confirmatory study, for potential licensing in Europe, but, when it comes to the European study design, we want to wait and see how big the effect of the drug is in the current trial," Ehrlich remarks."

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