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Prana Biotechnology Limited Message Board

goutah3006 42 posts  |  Last Activity: 14 hours ago Member since: Nov 29, 2004
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  • goutah3006 by goutah3006 14 hours ago Flag

    About the only near-term milestones that will be of any importance are: (a) the release of the efficacy results for the extension, and (b) the lifting of the clinical hold. The results, which I hope will be exciting (though I'm certainly not counting on it), should have been released by June 30th. Maybe they'll be released by July 30th. Their affect on the share price cannot currently be predicted. With regard to the clinical hold, we have no idea when that will be lifted, nor do we know whether it will be lifted. I reiterate that I can't see any way Prana can deliver new double-blind clinical results for anything before the mid-summer of 2017. And mid-summer 2017 is pretty optimistic.

    Sentiment: Hold

  • Reply to

    Speculation

    by goutah3006 Jul 2, 2015 11:42 AM
    goutah3006 goutah3006 Jul 3, 2015 12:09 PM Flag

    I don't think that Prana is deliberately holding back the efficacy results. I suspect that they haven't yet received the results, and that they will broadcast them within a day or two after they receive them. And I have no idea what those results will be. But, whatever they may be, they'll be the last clinical results we'll see for a long time.

    Sentiment: Hold

  • goutah3006 by goutah3006 Jul 2, 2015 11:42 AM Flag

    Well, we're still waiting for efficacy results from the extension. The safety results, while certainly good news, did not affect the share price, which remains near its all-time low. Will the efficacy results affect the share price? I have no idea, and neither does anyone else. But the market understands one key thing: We are years away from seeing material progress toward approval of a Prana drug. Approval of a Prana drug will require at least one more set of double-blind clinical results (presumably a Phase III for Huntington's). And there is simply no way we can expect such results any sooner than two years from now. And it will likely be longer than that. Or perhaps we'll never see further results. And we don't know whether those results will show efficacy. In the meantime, AD, which was supposed to be Prana's bread and butter, sits on the back burner, where it will remain for many years, if not forever. Unless, of course, the IMAGINE extension results are mind-blowinglly good, which they might be. But if they're not mind-glowingly impressive, there's simply no way Prana will be able to afford further AD clinical trials anytime soon, if ever. A year ago I was somewhat optimistic that Prana would get to the $3 to $4 ballpark. This was based on the assumption that a Phase III HD trial would get underway by late 2014 or early 2015. But I've lost that optimistic view. I'll continue to hold my shares until we see the IMAGINE extension results, but I won't be holding my breath.

    Sentiment: Hold

  • Reply to

    Reality

    by goutah3006 Jun 30, 2015 1:50 PM
    goutah3006 goutah3006 Jul 1, 2015 11:34 AM Flag

    Well, the news of the safety data from the extension trial has resulted in a share price of (drum roll, please) $1.21 (for US ADR shares). Not much of a catalyst, apparently. The next catalyst will be the efficacy results from the extension. Perhaps those will be exciting enough to boost the price significantly.

    Sentiment: Hold

  • Reply to

    Reality

    by goutah3006 Jun 30, 2015 1:50 PM
    goutah3006 goutah3006 Jun 30, 2015 11:43 PM Flag

    Bear in mind that 16 months have passed since Prana released the results of the Reach2HD trial. And nearly two years have passed since the final dose of PBT2 was administered to a Huntington's Disease patient. And we still have no announcement of a new Huntington's trial.

    Sentiment: Hold

  • Reply to

    Reality

    by goutah3006 Jun 30, 2015 1:50 PM
    goutah3006 goutah3006 Jun 30, 2015 3:21 PM Flag

    The above timeline takes into account the orphan drug designation and all the advantages it brings. If you expect to see new double-blind clinical results from Prana before the summer of 2017, please explain how such a thing would be possible. Give us a timeline as to when the next trial will start enrolling patients, how long the dosing will go on, when the last dose will be administered, and when the results will be made available. Give us a specific month and year for each such milestone and show us how we'll get clinical results any sooner than the summer of 2017.

    Sentiment: Hold

  • goutah3006 by goutah3006 Jun 30, 2015 1:50 PM Flag

    The reality: Even in the best-case scenario, we probably have to wait a couple of years before we see the next batch of double-blind clinical results (presumably for Huntington's), and even more years before we see new double-blind clinical results for Alzheimer's. Even if the IMAGINE extension results boost the share price enough to enable the raising of sufficient funds for a Phase III HD trial, and even if FDA removes the clinical hold tomorrow, it's hard to imagine Phase III results for HD becoming available any sooner than mid-summer of 2017.

    Sentiment: Hold

  • Reply to

    ANNOUNCEMENT! Safety outcome for AD extension!

    by pierreluke78 Jun 30, 2015 4:45 AM
    goutah3006 goutah3006 Jun 30, 2015 12:38 PM Flag

    This is certainly good news. We now await the efficacy results, which were supposed to be released by the end of June 30, 2015. In Australia it's now June 31.

    Sentiment: Hold

  • goutah3006 by goutah3006 Jun 26, 2015 1:01 PM Flag

    I keep seeing posts about various new opportunities for Prana (Parkinson's, multiple orphan designations for multiple diseases, brain statin, cancer, etc.). I once knew an elderly man who had formerly been in pretty good financial shape but who, during his last decade, was nearly destitute. He came into my office once a week to ask for money to buy food. I gave him $20 every time. He got evicted from his apartment, lost his car, and even lost his typewriter. He'd taken it to a repair shop but was unable to pay for the repairs, so the repair shop sold it. One day he came into the office and said "I've found a great deal on car insurance. I'm going to get car insurance so I can start driving again." I wanted to say "That's nice, George, but you don't have a car and you don't know where your next meal is coming from. So you probably shouldn't be shopping for car insurance right now." I didn't have the heart to say this, but my boss did. George was briefly silent, but as soon as the boss left the room, he resumed his enthusiastic schtick about getting car insurance.

    These Prana true believers are like George. Prana is burning money, its only clinical drug is on hold by the FDA, and it probably doesn't have enough money to do a Phase IIb clinical trial, let alone a Phase III. So all this talk about Parkinson's and orphan this and orphan that and ALD, etc. is the equivalent of George talking about getting car insurance.

    Sentiment: Hold

  • Could the recent price decline perhaps be attributable to the fact that Prana has not yet released the IMAGINE extension data? The company originally promised "first quarter of 2015", then changed that to "first half of 2015", which ends in two business days from today. Every time Prana management makes a promise to shareholders and then breaks that promise, the company loses a little bit of credibility. Of course, Prana still has two business days left (Australia time) to make good on its promise. Let's hope they do.

    Sentiment: Hold

  • goutah3006 goutah3006 Jun 25, 2015 1:46 PM Flag

    It may be that a few folks out there share my skepticism about Prana's ability to live up to its promises. Prana promised that we'd see the extension results during the first quarter of 2015. Then they changed that to the first half of 2015, which ends in three business days from now. Perhaps they'll revise it to "before the end of 2015." Who knows? The longer the company continues to burn cash without providing evidence of progress on the clinical path, the less $$ people will be willing to risk on this company.

    Sentiment: Hold

  • Reply to

    Four business days until deadline

    by goutah3006 Jun 24, 2015 11:08 AM
    goutah3006 goutah3006 Jun 24, 2015 6:33 PM Flag

    Thanks, copper. I appreciate the update on what kadaicher is posting. I don't know what trial he is referring to. Prana has never done a Phase IIb trial. Prana has done four Phase IIa trials, two of which had open-label extensions. A Phase IIa with extension for PBT1 on Alzheimer's patients, a Phase IIa of PBT2 on Alzheimer's patients, a second Phase IIa of PBT2 on Alzheimer's patients (the "IMAGINE" trial) with extension, and a Phase IIa of PBT2 on Huntington's patients. Prana had planned a Phase IIb of PBT2 for Alzheimer's and had promised that the trial would commence before the end of calendar year 2010, but December 31, 2010 came and went with no announcement of that trial. Prana had failed to raise the necessary funds to conduct it (an estimated $26 million was needed).

    Sentiment: Hold

  • Reply to

    Four business days until deadline

    by goutah3006 Jun 24, 2015 11:08 AM
    goutah3006 goutah3006 Jun 24, 2015 2:04 PM Flag

    I myself remain excited to see the extension results, because I have no idea what they will be. But one of the things I learned a long time ago is that Prana management is extremely unreliable when it comes to living up to its own promises. That's just who they are. They initially said "extension results will be released in the first quarter of 2015." Then they said "results will be released in the first half of 2015." The fact is that we're close to entering the second half of 2015, and we still lack the following:

    (a) IMAGINE extension results.
    (b) A lifting of the clinical hold imposed by the FDA.
    (c) An announcement of a new clinical trial.

    Prana remains at a standstill, burning cash without making material progress. How long Prana will remain at a standstill is anyone's guess.

    Sentiment: Hold

  • Prana originally promised that the IMAGINE extension results would be released during the first quarter of calendar year 2015. Then they said there had been a delay in achieving data lock, but they assured us that the results would be released in the first half of 2015, the end of which is next Tuesday. Prana management thus have four business days to break from its tradition of over-promising and under-delivering.

    Sentiment: Hold

  • Prana's self-imposed deadline for the release of the IMAGINE extension results is seven business days away.

    Sentiment: Hold

  • Reply to

    Two weeks to deadline

    by goutah3006 Jun 16, 2015 2:18 PM
    goutah3006 goutah3006 Jun 18, 2015 2:38 PM Flag

    Kepler does not know the results any more than you or I do. Nor will he sit on the results once he gets them. The date of AAIC is completely irrelevant.

    Sentiment: Hold

  • Reply to

    Two weeks to deadline

    by goutah3006 Jun 16, 2015 2:18 PM
    goutah3006 goutah3006 Jun 18, 2015 2:30 PM Flag

    June 30th is indeed a deadline, albeit self-imposed by the company. Of course, the company is operating under two constraints here: The company won't know the results until the independent trial administrators give them the results, and the company is required to release those results within a very short period of time after receiving them. So they're not going to sit on the results once they get them. But the can't force the trial administrators to release the results until the administrators are ready to do so. However, if results aren't released by June 30th, it will be another black mark against Prana management, which has a well-documented tendency of over-promising and under-delivering. They should not have announced a date of June 30th unless they had a lot of confidence that the results would be released by that time.

    Sentiment: Hold

  • goutah3006 by goutah3006 Jun 16, 2015 2:18 PM Flag

    Prana management originally told us that the results from the IMAGINE extension would be released in the first quarter of calendar year 2015. Then they told us the results had been delayed but would be released by the end of the first half of calendar year 2015. That would be June 30, 2015. Two weeks from today.

    Sentiment: Hold

  • Reply to

    Bad Scene

    by copper725 Jun 8, 2015 4:41 PM
    goutah3006 goutah3006 Jun 9, 2015 1:09 PM Flag

    Copper725 is a relative newcomer to the Prana message board. As is interestingtome1. I've been here for nine years and have owned shares (in varying numbers) during that entire time. My experience with Prana has been a good lesson for me in speculation. If you own a speculative stock and you want to have a decent chance of making a profit, you'll want to be continually probing for that company's weaknesses while at the same time remaining aware of its strengths. I learned this the hard way with previous speculative endeavors. As a result, I've made a net profit on Prana thus far by buying low and selling high (though not doing as much of the latter as I should have, obviously). If I didn't still think that Prana had a chance of making some sort of progress, I would have liquidated my remaining shares last year. Having said that, I should point out that my expectations for Prana have fluctuated over the years. At the moment, my expectations for Prana are lower than they've ever been. But they're not zero.

    Sentiment: Hold

  • goutah3006 goutah3006 Jun 8, 2015 11:41 AM Flag

    Note that Dr. Tanzi prefaces his "statin" remark with the word "hopefully". He is hoping that PBT2 will turn out to be effective and can be used as a statin. But he's open to the possibility that this won't be the case. As he has to be, since he's a scientist.

    Sentiment: Hold

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