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Acura Pharmaceuticals, Inc. Message Board

myop_ic 82 posts  |  Last Activity: Apr 1, 2014 1:12 PM Member since: Mar 12, 2013
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  • Reply to

    Linda, pivalde, kadaicher, et. al.

    by goutah3006 Mar 31, 2014 1:25 PM
    myop_ic myop_ic Apr 1, 2014 1:12 PM Flag

    Nobody "fabricated" the theory. Numerous animal studies and independent studies support it. The HD trial and p2a also corroborate PBT2 activity. The problem as I see is simple. You have an extremely safe drug, no SAE, with results that "hint" at efficacy. . . . SUBJECTS HAVE BEEN INSUFFICIENTLY DOSED. Another p2 with dose escalation is required, but with iterative cohorts based on dosing, it would be much more expensive. BUT that is the only path forward for PBT2 in AD.

    Sentiment: Hold

  • Reply to

    Is this worth buying here?

    by m_lewis.knit1 Mar 31, 2014 11:27 AM
    myop_ic myop_ic Mar 31, 2014 12:15 PM Flag

    I am out with a nice profit, as I have been trading Prana since 2008, but like most of you extremely dissapointed - particularly for the patients and families dealing with AD. That said, there is potential here with PBT2 in HD, much more work to consider AD and there is the PK candidate. My feeling is that they will examine the IMAGINE results and conclude a) subjects were clearly under-dosed and b) even as a p2, the trial design should have been stronger in looking at cognition at different disease states and in differentiating with placebo regarding the imagery (my biggest surprise). So....p3 for HD, probably another p2 or possibly p3 in AD with dose escalation and the p1 in PK. Results of the extension trial are now a complete guess, as those who were in the PBT2 arm were already dosed for 12 months.
    Such a pipeline plan takes money, i.e. partnership in HD possible but expect dilution before the end of the year. A fair value is likely in the range it is at now (2.80 - 3.5) is my guess.

    Sentiment: Hold

  • Reply to

    Was it PBt2 or placebo?

    by clovus Mar 30, 2014 6:07 AM
    myop_ic myop_ic Mar 30, 2014 10:51 AM Flag

    My guess is that the TV reporter covered both trials being undertaken and it was improperly edited. Typical. Also, the monoclonal antibody being evaluated is not a pill.

  • Reply to

    Emotional Friday

    by tomhitchcock86 Mar 29, 2014 1:29 PM
    myop_ic myop_ic Mar 29, 2014 2:32 PM Flag

    Brian, a very moving post that captures what many families contend with. He is a most fortunate man to lead such a caring, understanding family.
    BTW, who in the world would throw a thumbs down on this post? I realize we have a few idiots posting like they're in grade school, but gimme a break.

    Sentiment: Strong Buy

  • Reply to

    Personal Expectations for What it is Worth

    by opus12ga Mar 29, 2014 12:40 PM
    myop_ic myop_ic Mar 29, 2014 1:27 PM Flag

    I agree entirely, the prospects for clear, strongly shown efficacy are good based on 12 months of dosing and more definite differentiation with the placebo group, particularly on imaging.
    On the flip side, you would have had to PAY ME to hold a short position (and not having sold calls) this weekend since the upside next week is open-ended. One would have to a) follow AF and the argument that all AD drugs have failed, ergo this one will and b) totally ignore everything published, pre-clinicals, prior AD/HD trial results, safety profile, low FDA bar on AD, etc. etc.

    Sentiment: Strong Buy

  • Reply to

    How well the drug works does not matter

    by opend00rs Mar 29, 2014 12:36 AM
    myop_ic myop_ic Mar 29, 2014 12:59 PM Flag

    Exactly. Value to investors - and ultimate share price - is largely based on potential future revenue. The drug is very safe at 250mg. If then all diagnosed with AD are prescribed the drug, whether it is shown to be highly effective or only mildly effective, for the course of the disease, revenue will be similar. A blockbuster either way.

    Sentiment: Strong Buy

  • Reply to

    How well the drug works does not matter

    by opend00rs Mar 29, 2014 12:36 AM
    myop_ic myop_ic Mar 29, 2014 12:38 PM Flag

    You are correct. At 250mg the safety profile appears excellent, which is key. Pts may be on the drug for the course of the disease. The FDA bar on efficacy is low. But more to your point, any proven efficacy means a drug that will be given universally in AD, regardless of it's potency. In other words, mild efficacy shown and all dx with AD will receive the drug. Strong efficacy = all dx with AD will receive the drug. Market size roughly the same.
    For investors, the issue should be: will PBT2 warrant p3 and if so, what are the prospects at that point? If it goes to p3, and still shown to be safe, AND proves out with mild cognitive improvement OR favorable biomarker improvement, Prana and investors have a blockbuster as it will STILL be Rx to all with AD, and possibly related indications (MCI). IF IMAGINE shows statistically strong efficacy the process, and price appreciation will merely be faster. . . . but ultimately market potential would be the same.

  • Reply to

    Sitting on my hands

    by seriously211 Mar 28, 2014 3:35 PM
    myop_ic myop_ic Mar 28, 2014 3:40 PM Flag

    May not work. I've had to hit the trade button with my nose.

    Sentiment: Strong Buy

  • IF trial results are not released prior to the presentation, as it appears, what do we look for from the presentation? Presumably they have numbers and a runway forward, but cannot legally "spill the beans" on IMAGINE.
    "We remain extremely confident in PBT2" would be nice to hear.
    Actually anything specifically referring to PBT2 as being a promising contender against AD (as they did at the NYAS Symposium in 2012) would be encouraging (for longs - scary for shorts).
    Otherwise, the presentation might fall back on explaining the metal hypothesis with Prana having a wide range of potential MPAC library candidates as part of their IP assets for future IND development in AD as well as existing HD and PK candidates. Any presentation on MPAC without PBT2 showcased would "spoil my weekend".

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 28, 2014 9:35 AM Flag

    Yes, it is reasonable speculation. But of course, we will know by Monday if not today. That said, most are baked in long or short (scary) and everyone assumes the stock price will be radically different on Tuesday. Those with a largely hedged position, with so much upside potential. . . well, it's like non-alcoholic beer. It may quench your thirst but what's the point.

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 28, 2014 9:14 AM Flag

    Calm down and tell us what you are talking about. Do you KNOW something about the trial results being released today that no body else outside the company knows? I only run on news with 4 or more exclamation marks.

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 27, 2014 11:11 AM Flag

    Thank you. Informative post (refreshing) and sound, substantiated opinion regarding the timing here.
    Appreciated.

    Sentiment: Strong Buy

  • Reply to

    I blame the large holders for this like rkf!

    by ltmarigold Mar 27, 2014 8:52 AM
    myop_ic myop_ic Mar 27, 2014 10:03 AM Flag

    You may be highly rewarded this time. But if you continue to buy small biotechs AFTER they are priced for an impending catalyst your portfolio will suffer greatly. Most IND fail. These are not tech stocks or even mid-cap healthcare firms. The key is to consistently identify opportunities very early and vet based on management record, financial conservatism. . . .and then the pipeline and it's underlying science. A lot of homework that very few professional analysts can advise on.
    I personally look at IND for unmet needs, novel platforms, stellar pre-clinicals, safety in p1 and then we go much deeper into the prospects - IMO you need to understand the statistical basis of trials and a good - not expert - understanding of the science. I've been trading Prana big time - since 2008 - at an avg. price now of about $1.20 (with recent purchases). There are ALWAYS other biotechs that could be played the same way, even if short positions or options are not in your repertoire. It's just hard work to identify them and have the knowledge and confidence to stick with them. And then you don't always see a profit.
    This approach can work - if you have the time, skill-set and knowledge base - because in fact there is no biotech "bubble" going on. The sector will continue to blossom due to improved research tools, very fundamental improvements in genetics, newly proven and exploited platforms, broader funding grants, imaginative researchers focusing on specific fields, etc. Prana is a great example over their last 10 years.
    So hold on and let's see. My prediction is that results will be released in March :).

    Sentiment: Strong Buy

  • Reply to

    Expecting results Thursday

    by brewman228 Mar 25, 2014 9:23 PM
    myop_ic myop_ic Mar 26, 2014 9:30 AM Flag

    Reasonable scenario and timing falls in-place. I personally predict the announcement will be sometime in March :).
    But Brewman, curious message boarders need to know much more, like on TMZ. Where are they having lunch on Thursday? Flying in to JFK, LGA or even perhaps BOS to meet with Tanzi tonight and drive down together? Nah.
    I am really unable to evaluate Prana as an investment without such pertinent data. :)

    Sentiment: Strong Buy

  • Reply to

    For What it's Worth

    by grandma_of_stash Mar 21, 2014 5:18 AM
    myop_ic myop_ic Mar 21, 2014 7:37 AM Flag

    Granny, tell us. Has little Stash learned anything about message board etiquette since those years ago?
    Everyone can learn to be good.

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 20, 2014 4:37 PM Flag

    There should be no obstacles to providing a 6 month interim report, particularly since the trial continues in Au. That said, they have not announced that intention to my knowledge. If IMAGINE results are positive on any endpoint, such a report might be issued in July to indicate continued safety, if not further efficacy (now that we would know IMAGINE results). Such data would also be a factor in considering the p3 design.

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 20, 2014 4:19 PM Flag

    To clarify, the p2a results as re-examined were not ambiguous. The HD results on cognition are shown as positive for TMTB and being peer reviewed. That's where they stand. They have been refuted by some. The duration of IMAGINE and considering these prior results, points to a stronger, definitive PR release next week (presumably).

    Sentiment: Strong Buy

  • myop_ic myop_ic Mar 20, 2014 4:14 PM Flag

    Many are not considering the additional power related to the 12 month vs the 12 week p2a or 26 week REACH2HD, even if pts are being under-dosed at this point. Aside from the number of subjects, progression is going to be more clearly defined. Thedifference in the 250mg arm vs placebo will be more clearly seen in the results. As an example, run the same trial for a month and it is impossible for any drug to show efficacy on progression - since it cannot be measured. The point is that previous findings and what could have been subtle imagery changes at 26 weeks, should not be ambiguous here. Correct me if I am missing something here, but perhaps the columnist "experts" will be left with little open to refute on this one.

    Sentiment: Strong Buy

  • Reply to

    If the FDA doesn't Respond

    by gizmo_puppy95 Mar 18, 2014 12:29 PM
    myop_ic myop_ic Mar 18, 2014 4:34 PM Flag

    Excellent post.

    Sentiment: Strong Buy

  • Reply to

    I'm done

    by lee1220neill Mar 18, 2014 3:18 PM
    myop_ic myop_ic Mar 18, 2014 4:33 PM Flag

    Are you the same as "lee122oneill" with a small o, or are you a very transparent impostor.
    This is about as slimy as it gets on a message board.
    BTW - you clearly do not understand this price action. But now that you are out the bonus is that we won't see your posts taking up space.

    Sentiment: Strong Buy

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