Recent

% | $
Quotes you view appear here for quick access.

OncoGenex Pharmaceuticals, Inc. Message Board

biotechinvest1077 892 posts  |  Last Activity: Apr 3, 2016 2:50 PM Member since: May 27, 2008
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Here's your example Mudbug021

    by pert.near Apr 3, 2016 9:35 AM
    biotechinvest1077 biotechinvest1077 Apr 3, 2016 2:50 PM Flag

    JimmyGreaves,

    You said, "Not really. The P2s were pretty much done, S had already ACED them, by curing every patient. I think more interesting may be that there never really was a P3, as such."

    While the first part of your statement is true, the last part isn't. You probably got the last part about Sovaldi never really having a Phase 3 from Holdencf. A few months back he 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...."

    But the fact is GILD's Sovaldi was only approved after four (4) Phase 3 trials. Holden often shoots from the hip. He is prone to making grand claims that are factually wrong.

  • biotechinvest1077 biotechinvest1077 Mar 7, 2016 8:00 PM Flag

    For me the key question relates to whether or not Arbutus's lead HBV compound effectively targets integrated DNA.

    This is the 64,000 dollar question as it directly impacts ARWR's current 2 year lead in the clinic.

    So the question is: "Does Arbustus's ARB-1467, their lead HBV compound currently in Phase 2 for HBV, effectively target iDNA?"

  • biotechinvest1077 by biotechinvest1077 Mar 1, 2016 12:43 PM Flag

    CYTK seems cheap w/ Omecantiv having legit blockbuster potential. What is Amgen waiting for?

    Sentiment: Strong Buy

  • Reply to

    The CC

    by dig_a_little_deeper_1 Feb 13, 2016 9:00 PM
    biotechinvest1077 biotechinvest1077 Feb 15, 2016 7:33 PM Flag

    Holden,

    In prior posts you have stated that the FDA wants to discourage early stage trials taking place in the US. Assuming I am restating you accurately, please tell me where the FDA has made such an assertion. I ask because I haven't been able to confirm same and it seems counter-intuitive to me.

  • Reply to

    ALN-HBV Delayed

    by investron Feb 12, 2016 4:04 PM
    biotechinvest1077 biotechinvest1077 Feb 13, 2016 7:38 PM Flag

    HP,

    What was it about Steve's post that you are responding to?

    Do you think Steve was repeating ALNY's current HBV line because he is hopelessly naive, a shill for ALNY, or do you think perhaps he is simply trying to correct the widespread view on this message board that ALNY's HBV program is for all intents and purposes dead in the water?

    Personally, I think Steve is responding to the latter, but since I respect your opinion, perhaps I am overlooking something that resulted in your post.

  • Reply to

    30 Hospital Target

    by aeishh Feb 9, 2016 11:25 AM
    biotechinvest1077 biotechinvest1077 Feb 11, 2016 11:39 PM Flag

    Agreed. I'd be very surprised if the goal of hospital placements/sales was not met precisely for the reason you state.

  • 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.

OGXI
0.997+0.047(+4.95%)Jun 28 3:56 PMEDT