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Prana Biotechnology Limited Message Board

goutah3006 35 posts  |  Last Activity: May 26, 2015 12:12 PM Member since: Nov 29, 2004
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  • Reply to

    Review of EMA Comp Decisions

    by interestingtome1 May 26, 2015 9:33 AM
    goutah3006 goutah3006 May 26, 2015 12:12 PM Flag

    Even if Prana receives orphan designation, they'll still have to do further clinical testing, which will cost money.

    Sentiment: Hold

  • Reply to

    milking it

    by copper725 May 22, 2015 2:32 PM
    goutah3006 goutah3006 May 24, 2015 11:51 AM Flag

    I've been a Prana shareholder since July 2006. How long has interestingtome1 been a Prana shareholder? And, more importantly, why does he refuse to entertain even the mildest skeptical thoughts about Prana? An intelligent speculator should always be eager to make himself aware of a company's potential problems, especially if he owns shares of that company. Seeing everything through rose-colored glasses 100% of the time is a great way to lose money.

    Sentiment: Hold

  • Reply to

    No real news - Last month's EMA meeting minutes

    by copper725 May 21, 2015 10:00 AM
    goutah3006 goutah3006 May 21, 2015 11:17 AM Flag

    Yup. Not much in the way of actual news. Just a rehash of last month's press release, with a few additional details. The EMA is recommending PBT2 for orphan designation. Even if orphan designation is granted, Prana will still have to apply for permission to market the drug in Europe, which will likely require an additional clinical trial.

    Sentiment: Hold

  • Reply to

    Extension Trial

    by rahpran May 20, 2015 8:28 AM
    goutah3006 goutah3006 May 20, 2015 1:25 PM Flag

    No, they won't compare to placebo because no patients were given placebo during the extension. I suspect that they'll highlight those extension patients who received PBT2 during the main trial and who therefore had 24 months of dosage. Then they'll probably compare the cognitive scores of those 24-month patients with existing data for people outside the trial who were at a similar disease stage and who received no treatment for a similar period, or who were using a currently-approved treatment such as Aricept for a similar period. And we'll probably have some additional safety/tolerability data that could be useful, despite the lack of placebo in the extension. Unfortunately, the number of patients who received PBT2 for 24 months is a pretty small sample size. And some of them were interrupted in their dosage (i.e. they finished the main trial before the extension trial began). But the results may be interesting nonetheless. I'm excited to see them because they may provide some additional insight.

    Sentiment: Hold

  • Reply to

    Waffles

    by copper725 May 19, 2015 6:50 PM
    goutah3006 goutah3006 May 20, 2015 1:04 PM Flag

    I long ago added kadaicher to my ignore list for several reasons, one of which is that he regards as a heretic anyone who doesn't share his faith-based absolute confidence that gazillion-dollar success for Prana is just around the corner. He once went so far as to accuse me of being a short-seller simply because I expressed the opinion that Prana's future success was not a sure thing and that there were risks involved in owning this stock. I still own shares, though (thank goodness) I sold a large portion of my shares during the run-up of late 2013 and early 2014. Prana may still find success, but the company's prospects get weaker with each additional year that goes by without compelling clinical results.

    Sentiment: Hold

  • goutah3006 goutah3006 May 19, 2015 2:10 PM Flag

    You're right that the stock market generally isn't an easy way to make money, though I would add one caveat: With the right attitude (which most people lack), it's pretty easy to make money in stocks over the long run. The pumpers here, for the most part, don't seem to have the right attitude. If they did, they would have been selling some of their shares in early 2014 as the price rose. Instead, they were holding all their shares and/or buying shares as the price went up. And they wouldn't have had more than a small percentage of their portfolios devoted to Prana. If, in early 2014, you had told the pumpers here that the ADR share price would be $1.25 on May 19, 2015, they would have responded with howls of derision.

    Sentiment: Hold

  • goutah3006 goutah3006 May 15, 2015 1:03 PM Flag

    Yes, that mouse study was interesting. As were previous mouse studies of PBT2. But human trials are all that really count at this stage of Prana's evolution. If share price were determined by mouse studies, we'd be at $20 right now.

    Prana does not have enough money to perform any clinical trials of PBT2 for either Alzheimer's or normal age-related cognitive decline. Unless the clinical hold gets lifted soon, Prana will probably not even have enough cash left to do a Phase III for Huntington's.

    Sentiment: Hold

  • goutah3006 goutah3006 May 15, 2015 3:19 AM Flag

    PBT2 was recently granted orphan-drug status in Europe, which is one of the four "catalysts" mentioned by ITM that, in her opinion, could propel the price to $100. This news brought the share price up to the stratospheric $1.20 ballpark we're enjoying today.

    So what about the three other catalysts on her list? Let's look at the clinical hold. Prior to the announcement of the clinical hold, the price was about $1.50 if I recall correctly. If the hold were lifted tomorrow, we might expect the price to climb back to those levels. Or maybe less, given that time and money are wasting away while we wait for the hold to be lifted.

    What about orphan status for other MPACs? Orphan status for PBT434 seems extremely unlikely because Parkinson's is not a rare disease like Huntington's. And even if it were, we'd probably have to wait for Phase II results before orphan status would be granted. Ditto for PBT1033.

    Thus, one of ITM's four catalysts has already occurred, two are extremely unlikely to occur, and the remaining one (lifting of the clinical hold), if it happens, will merely put Prana back where it was a few months ago, albeit a few million dollars poorer and a few months further behind schedule. How, exactly, is this supposed to propel the share price to $100?

    Sentiment: Hold

  • goutah3006 goutah3006 May 14, 2015 3:29 PM Flag

    It's extremely unlikely that these four events, even if they were to happen within a few days of each other, would send the share price from its present level to $100. Such thinking is delusional in my opinion.

    Sentiment: Hold

  • Reply to

    Imagine yourself the extension study results

    by pivalde May 9, 2015 12:22 PM
    goutah3006 goutah3006 May 10, 2015 11:46 AM Flag

    The IMAGINE extension results will probably be the last clinical results we will see from Prana for a long time, if ever. But they might be interesting and maybe even attention-getting. Or they might be disappointing. This uncertainty is what makes the whole thing exciting.

    Sentiment: Hold

  • Reply to

    Time and priorities

    by copper725 May 6, 2015 8:27 AM
    goutah3006 goutah3006 May 6, 2015 10:08 AM Flag

    Prana's cash position is rapidly declining. As each additional month passes without the clinical hold being lifted, the probability increases that no clinical trials will be initiated in 2016. Time is indeed money.

    Several years ago, I mentioned that one possible scenario for Prana was liquidation, i.e. the company closes its doors, sells its IP portfolio to the highest bidder for a tiny fraction of what it cost to develop this portfolio, pays off its obligations, and distributes the remaining meager assets to shareholders. I wasn't predicting that this would actually happen; just pointing out that we shouldn't rule out the possibility that it would happen. The mere mention of this possibility produced howls of derision from the faithful, but it remains a possibility.

    Sentiment: Hold

  • Reply to

    Quarterly report out on ASX

    by brewman228 Apr 27, 2015 11:32 PM
    goutah3006 goutah3006 Apr 28, 2015 4:09 AM Flag

    That works out to a burn rate of $13 million per year, without any clinical trials underway. That's a pretty big burn rate. Prana's normal burn rate not counting R&D costs is between $5 million and $6 million per year.

    Sentiment: Hold

  • goutah3006 goutah3006 Apr 28, 2015 3:49 AM Flag

    Originally the results were expected to be released by now, but management indicated that there were data problems, so they pushed the deadline out until the end of June. Which, in Prana-speak, means "sometime before the end of July or maybe August".

    Sentiment: Hold

  • goutah3006 goutah3006 Apr 23, 2015 9:27 AM Flag

    We're getting into the realm of wishful thinking here. We have no idea what sorts of negotiations, if any, are taking place between Prana and the FDA, because Prana has provided no details. We don't know what, exactly, the FDA will require from Prana in order to get the clinical hold removed. Prana is largely silent about all of this, so people are trying to guess as to what the FDA is up to and what its motives are. Some people are constructing imaginary scenarios and presenting them as if they were a near-certainty, as in ITM's claim that "the partial clinical hold was a stop gap implemented by the FDA in response to an application for accelerated approval for HD."

    Sentiment: Hold

  • goutah3006 goutah3006 Apr 18, 2015 12:21 AM Flag

    An interesting mouse study, indeed. A few points to consider:

    1 - A clinical trial of PBT2 for age-related cognitive decline is something we would all love to see, but such a trial would probably have to be large and lengthy and expensive in order to be powered to detect efficacy in normal age-related cognitive decline.

    2 - Prana has nowhere near enough money to conduct a clinical trial of PBT2 for age-related cognitive decline.

    3 - The FDA's clinical hold on PBT2 applies not just to Huntington's, but to any use of PBT2 in the USA. So the clinical trial would have to be done elsewhere unless Prana can convince the FDA to drop its clinical hold. Not a problem, really, except that Prana will eventually want to enter the U.S. market with its drugs.

    4 - The two Phase IIa trials of PBT2 whose results were published last year were disappointing despite the fact that both trials had been preceded by impressive mouse studies.

    5 - Prana has nowhere enough money to conduct a clinical trial of PBT2 for age-related cognitive decline.

    Sentiment: Hold

  • Reply to

    An alternative-past scenario

    by goutah3006 Apr 17, 2015 12:10 PM
    goutah3006 goutah3006 Apr 17, 2015 12:37 PM Flag

    Correction: I incorrectly wrote "2009" when, in fact, I should have written "2010". The election was in 2010, and enrollment in the proposed Phase II trial was supposed to begin by the end of calendar year 2010.

  • In 2009, Prana announced plans for a full Phase II trial of PBT2 for Alzheimer's, powered to detect cognitive endpoints. Estimated cost for this proposed one-year trial was $26 million. Prana expected to be able to pay for this trial with the help of a grant from the Victoria state government, which was at the time controlled by the Labour Party. The promised grant, which was in the $16 million ballpark if I remember correctly, was conditioned on the reelection of the Victorian Labour government later that year. In other words, the Labour government said "we'll give you the money after the upcoming election." But the Labour Party lost the election and was not returned to power. So the grant never materialized. The whole thing seemed a bit dubious to begin with. Geoffrey Kempler gave a radio interview prior to the elections and was excited about the Phase II and the grant, and he glossed over the fact that the grant was, at the time, little more than a campaign promise that hinged on the outcome of the election. After Labour lost the election, Kempler talked about other ways to fund the trial, but the hoped-for funding never happened and the plan for a full Phase II was quietly abandoned.

    If Labour had won that election, and had delivered the money, there's a pretty good chance we would have seen results in mid-2012 from a trial large enough to detect cognitive efficacy or lack thereof.

    One lesson from this (aside from "don't base your company's future on a politician's campaign promises") is that money is important for Prana, and without adequate money Prana won't be able to prove the efficacy of its drugs.

    Sentiment: Hold

  • Reply to

    Prana Mystique

    by copper725 Mar 27, 2015 5:58 AM
    goutah3006 goutah3006 Apr 16, 2015 11:20 AM Flag

    I agree, in hindsight, that a one-year Alzheimer's trial with a large sample size and cognitive endpoints without imaging would have been the way to go after the Euro trial. But the stubborn fact remains that Prana didn't have enough money to do such a trial. Such a trial was, in fact, planned and announced by Prana years ago. It was not a Phase III trial, but a full Phase II (the Euro trial having been a Phase IIa). Prana management promised that the trial would commence enrolling people by the end of calendar year 2010. This deadline came and went with no announcement, because Prana simply did not have anywhere near enough money to fund the trial. Management stopped talking about this Phase II, and soon started talking about a Phase IIa for Huntington's as being a cheaper way to go. Then, within a few months, they started talking about the IMAGINE trial as being a cheap way to get Big Pharma interested in PBT2 for Alzheimer's. I still think this approach made sense, given what was known at the time and given Prana's chronic inability to raise enough money to fund a full Phase II for Alzheimer's. Unfortunately it didn't pan out. Now we have a new conundrum: Prana has put Alzheimer's on the back burner in order to pursue Huntington's (the company doesn't have enough money to pursue both, let alone Parkinson's), but the company's Huntington's program has been placed on hold by the FDA.

    Sentiment: Hold

  • goutah3006 by goutah3006 Apr 7, 2015 2:30 PM Flag

    Due to my stone-age internet, my ignore filter was temporarily disabled and I was able to see that kadaicher had posted "manipulation = low price = opportunity". I read most of the text of his post before my filter kicked in. He claims that the only reason the share price is about $1 is because the stock is being "manipulated". This is nonsense. I've seen one probable case of manipulation of a stock I owned, and its effect on share price was transient and brief. Prana's share price is being held down not by manipulators, but by the market itself. Sometimes the market gets things wrong, of course, and sometimes it gets things way wrong. And sometimes it gets things right. But rarely if ever does a stock's price remain artificially high or artificially low for prolonged periods due solely to "manipulation". At the moment, the market correctly sees that Prana is in a pretty poor situation. Kadaicher, in his post, claims that Prana is flush with ample cash to pursue multiple projects on all sorts of different MPAC applications. Wrong. The company may barely have enough cash to do a Phase III for Huntington's and keep the lights turned on at corporate headquarters. And such a Phase III, assuming the FDA drops its clinical hold, probably won't get started until sometime in 2016. Which means we probably won't see results until late 2017. In the meantime, clinical work on Alzheimer's and Parkinson's will have to be sidelined, with the possible exception of a simple one-week Phase I of PBT434. Prana is trading at $1 simply because the company's situation sucks. This can change at any time without warning, of course, but at the moment we don't have any information that would give us confidence in such a turnaround.

    Sentiment: Hold

  • goutah3006 goutah3006 Mar 27, 2015 10:39 AM Flag

    Prana designed a full Phase II trial of PBT2 for Alzheimer's using cognitive endpoints and a much larger sample than the Phase IIa Euro trial. I believe the only biomarker for that trial was CSF a-beta. No imaging was planned. They announced that enrollment for this Phase II trial would begin by the end of 2010, with a one-year dosage period. Estimated cost for the trial was $26 million. However, Prana did not have enough money, so they never started that trial. The IMAGINE trial was then introduced as a cheaper alternative (about $10 million, if I recall correctly). But the IMAGINE trial turned out to be inadequate. As always, it boils down to lack of money. Prana's current cash reserves will likely be burned up in pursuit of validating PBT2 for Huntington's, assuming the FDA's clinical hold gets lifted. So I'm not expecting another Alzheimer's trial anytime soon.

    Sentiment: Hold

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