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Prana Biotechnology Limited Message Board

goutah3006 92 posts  |  Last Activity: 21 hours ago Member since: Nov 29, 2004
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  • goutah3006 goutah3006 21 hours ago 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

  • Reply to

    Pfizer acquistion in the cards?

    by cvackerson Mar 26, 2015 9:46 AM
    goutah3006 goutah3006 Mar 26, 2015 10:49 AM Flag

    Prana has been trying to get into a partnership with Big Pharma for the past seven years, but without success. What makes you think that Big Pharma suddenly finds Prana more attractive now than it did last year or the year before that or the year before that? With regard to an outright acquisition, such an offer would probably only be accepted on a last-ditch basis by Prana. Prana, wisely, would prefer a form of funding that would maximize shareholder value in the event that one of Prana's products becomes successful, in no small part due to the fact that Mr. Kempler owns a lot of shares. A partnership would accomplish this. An acquisition would not. An acquisition might happen if all other options had been exhausted, and at that point the acquisition price would probably be pretty low.

    Sentiment: Hold

  • Reply to

    I guess all great stocks fall 90% right?

    by rick_horvath53 Mar 24, 2015 5:04 PM
    goutah3006 goutah3006 Mar 25, 2015 11:51 AM Flag

    The risk/reward ratio at this point is somewhat less relevant than the potential opportunity cost of putting money into Prana stock. The next results from a double-blind clinical trial to test for efficacy of a Prana drug wiill be released.....when? Mid-2017 at the earliest. And, of course, we don't know whether those results will be good. If you have money to invest, you'd be better off looking for a company that's currently selling at bargain prices relative to its fundamental value. Prana, of course, has no knowable fundamental value. That's because we don't know what its intellectual property is worth. One can talk about the value of Prana's cash, but that's not really a useful valuation metric because Prana's cash is a burnable commodity that does not get replenished from product sales.

    Sentiment: Hold

  • goutah3006 by goutah3006 Mar 19, 2015 3:46 PM Flag

    I remain skeptical about stock-manipulation theories. I get a kick out of watching some of the longs on this message board talk about "stock manipulation" whenever the price drops 7% in one day. But when it goes up 7% in one day, as it has done today, these same people either say nothing, or they claim that the price increase is due to "impending good news" or whatever. If they truly believe in manipulation, why to they believe that stock is only susceptible to manipulation in one direction?

    Sentiment: Hold

  • Reply to

    Near Term Catalysts

    by schieboutz Mar 17, 2015 10:08 AM
    goutah3006 goutah3006 Mar 19, 2015 1:59 PM Flag

    The IMAGINE extension results in which I'll be most interested will be the cognitive endpoints, compared with the historical cognitive data for untreated Alzheimer's patients at a similar stage of the disease. If PBT2 is as effective as we'd like it to be, two years' dosage ought to show some sort of benefit.

    Perhaps PBT2 is the whiz-bang AD drug we've all been hoping for. But Prana's challenge is, as it always has been, financial. They simply don't have enough money to do the next phase of clinical testing for Alzheimer's. The resources they currently have will likely be consumed in a combination of clinical work on Huntington's Disease and covering basic operating cash-burn. Aside from the IMAGINE extension and a possible Phase I for PBT434 (which will reveal nothing about efficacy), we are unlikely to see ANY new clinical results from Prana until early 2017, if ever. And the 2017 results will likely be for Huntington's.

    Sentiment: Hold

  • Reply to

    AD Extension report

    by juniorsbro Mar 18, 2015 12:21 PM
    goutah3006 goutah3006 Mar 18, 2015 12:53 PM Flag

    I, too, don't like being preached to at Starbucks. And the new corporate policy requiring Starbucks baristas in America to initiate conversations about race when handing the product to the customer indicates to me that the CEO of Starbucks may have dementia.

    With regard to the IMAGINE extension, Prana management mentioned in the recent annual report that the results are expected to be released sometime in the first half of calendar year 2015. There appear to have been some data issues that are taking extra time to clear up. So I've set June 30th as the target date.

    Sentiment: Hold

  • Reply to

    Near Term Catalysts

    by schieboutz Mar 17, 2015 10:08 AM
    goutah3006 goutah3006 Mar 17, 2015 11:52 AM Flag

    Hi, schieboutz. I've owned Prana shares for the better part of a decade and have observed that catalysts for this stock are hard to predict, as is the effect those catalysts will have (i.e. do they catalyze the stock price upward or downward?). Some catalysts have happened out of the blue and were totally unexpected, such as the recent clinical hold that dropped the share price 30%. Other catalysts were predicted but had the opposite effect of what was expected, such as the two clinical-trial results that were released last year, each of which caused the share price to decrease instead of increase. The only scheduled event on the horizon is the release of the IMAGINE extension results, presumably sometime before June 30th. I have no idea what those results will be or how they will affect the share price. I'm not sure why you're asking kadaicher about this, given his poor track record of predictions. I suspect he'll tell you that the IMAGINE extension results will make this stock an instant 50-bagger or whatever. He's been saying that a 10x or 20x or 50x jump in share price is "just around the corner" and "a slam dunk" for many years now. Maybe one of these years he'll happen to be right.

    Sentiment: Hold

  • Reply to

    Cramer on Stock Manipulation

    by interestingtome Mar 15, 2015 9:54 AM
    goutah3006 goutah3006 Mar 16, 2015 12:42 PM Flag

    One thing I've noticed about manipulation theorists is that they only think a stock is being manipulated when the share price isn't going in the direction they want it to go. When Prana's share price is declining, for example, a few of the perennial longs sometimes claim that the decline in price is caused by evil manipulators. When Prana's share price is on its way up, these same people claim that the price is increasing because good news is imminent and the market is finally acknowledging Prana's potential, etc.

    While skilled manipulators may be able to slightly influence the short-term fluctuations of a stock's share price (I remain skeptical as to how much power they actually wield), they can't have long-term impact on average prices. The reason Prana's stock is in the $1 ballpark isn't because manipulators are holding it there. It's because the company has had a string of bad news for the past year and its future prospects are highly uncertain at this point.

    I doubt that the trolls on this board are skilled manipulators, though a few of them may have deluded themselves into actually regarding themselves as such. I've only seen one instance that I strongly suspect was manipulation of a stock I owned (the now-defunct Brillian Corporation). That was in the summer of 2007. It appears that one or more clever short-sellers managed to take advantage of an unusual situation to push the share price downward over a period of a few days. They didn't bother to use the message boards because they were too smart to waste time in that fashion.

    Sentiment: Hold

  • Reply to

    5 stages of grief:

    by ohio_buckeyes_steve Mar 4, 2015 3:20 PM
    goutah3006 goutah3006 Mar 13, 2015 2:07 PM Flag

    People still don't understand that the future of Prana depends on double-blind clinical trials. There are no such trials currently underway for any Prana drug, nor are any such trials scheduled. The probability of seeing the results of a double-blind clinical trial in calendar year 2016 are rapidly vanishing. Thus, it's likely that we'll have to wait until at least calendar year 2017 to see the next set of double-blind clinical trial results.

    Sentiment: Hold

  • goutah3006 goutah3006 Mar 10, 2015 1:42 PM Flag

    Technical analysis of Prana stock is completely useless and meaningless. One cannot use past share-price data to predict future share prices for this stock. The "analysis" by Erica Dunham is particularly silly. The stock goes up a penny and a half and she tells us that this is "a clear sign of heightened optimism". Even if it is, so what? We've had many such "clear signs of heightened optimism" in the past, and they've led exactly nowhere. All that counts for Prana is successful clinical trials. They haven't had any successful clinical trials yet (yes, I know, blah, blah, blah), nor have any future clinical trials been announced.

    Sentiment: Hold

  • goutah3006 goutah3006 Mar 7, 2015 3:44 PM Flag

    I put rkf on my ignore list long ago. Based on the few posts I've seen during brief periods when my filter was disable, I speculate that he has either a strong emotional attachment to Prana or he put a lot of money into Prana stock (or both) and that he's perhaps a bit distraught and/or in denial over the company's ongoing misfortunes and the collapse of the share price. I've seen it happen before with holders of other nano-cap stocks that went south. People sometimes identify a bit too strongly with companies they believe in.

    Sentiment: Hold

  • Reply to

    Nothing but nothing but news

    by rcros92 Jan 9, 2015 1:24 PM
    goutah3006 goutah3006 Mar 3, 2015 10:02 AM Flag

    Part of the allure of Prana is the "hidden treasure" phenomenon. That's the reason I bought Prana in the first place. It's kind of like the people who dig for treasure on Oak Island. There's this legend of a buried treasure on the island that's worth tens of millions of dollars, or, according to some of the wilder theories, billions of dollars. It was supposedly buried in a way that makes it challenging to find and retrieve. Every time an effort to find the treasure fails, the diggers come up with an explanation that includes what they interpret as tantalizing evidence that they came "this close" to finding it. They just need to drill a borehole from a different angle, or whatever, but winter is setting in and they'll have to wait until next season, or whatever. People have been digging for treasure at this location for a century or more with no luck.

    With Prana, the big allure is the possibility that MPACs could be a huge leap forward in the treatment of multiple neurodegenerative diseases, with an annual market of billions or tens of billions of dollars.

    We never seem to strike the treasure, however, and Prana keeps coming up with explanations as to why we "just missed it this time". These explanations may indeed be valid. But after enough misses, some of us begin to wonder whether PBT2 and other MPACs are the magic elixirs we thought them to be, and we become increasingly frustrated with this company, although we refuse to completely abandon the possibility that Prana's scientists might be on to something. Others maintain 100% absolute faith that the treasure chest is just around the corner and that PBT2 is a "sure thing". In the eyes of some of the true believers, anyone who expresses the slightest bit of skepticism is a heretic. It's almost a religious sort of fervor.

    Sentiment: Hold

  • Reply to

    The $40.5 million question

    by goutah3006 Feb 25, 2015 2:22 PM
    goutah3006 goutah3006 Mar 2, 2015 4:11 PM Flag

    The 50% U.S. orphan-drug tax credit is a good thing, but because Prana doesn't pay taxes in the USA and doesn't have any earnings on which to pay taxes anyway, this won't help Prana's cash flow situation anytime soon unless something like the following scenario takes place: suppose that a Big Pharma company that is either based in the USA or has a significant tax-paying presence in the USA partners with Prana and pays for an orphan-drug Phase III of PBT2 for Huntington's disease conducted in the USA. That Big Pharma company could then benefit from the 50% tax credit in real time. The benefit to Prana is that Prana wouldn't have to pay for the Phase III. It would be a win-win, in the sense that Big Pharma gets a big tax credit, along with a piece of the action in the event that PBT2 gets approved for Huntington's, while Prana would be able to deploy its cash for other projects while still retaining a piece of the action in the event that PBT2 gets approved for Huntington's.

    Sentiment: Hold

  • goutah3006 by goutah3006 Mar 1, 2015 2:24 PM Flag

    The 48-week extension of the Phase IIa trial of PBT1 for Alzheimer's was interesting. The original Phase IIa enrolled 18 patients and lasted 36 weeks. Nine patients completed the extension. I can't remember the breakdown on placebo vs. drug, but the results for people who were on the drug for both the main trial and the extension were interesting despite the tiny sample size. ADAS-Cog scores declined slower than they would have for a similar population not receiving treatment. And MMSE scores hardly declined at all for those who received PBT1 for the full 84 weeks. But it was a tiny sample.

    The results were released in October 2004. The share price rose 20% or so over the next few days, but within a few weeks the price settled back down to the range it had been in before the results were announced.

    The IMAGINE extension had a larger sample, and some people received the drug for a full 104 weeks. So I look forward to seeing the results if and when they get released. Whether they have much of an effect on share price remains to be seen, but I'll probably hold my remaining shares until the results have been made public.

    Sentiment: Hold

  • Reply to

    A Buy if 12 month Investment Horizon?

    by schieboutz Feb 27, 2015 11:16 AM
    goutah3006 goutah3006 Mar 1, 2015 1:19 PM Flag

    Another point about catalysts: Clinical results are supposed to be the big catalysts for this company. They are few and far between, but they're the big kahunas that everyone anticipates. So it's worth looking at the effect of past clinical results on Prana's share price. We've had four sets of clinical result since I became a shareholder. The Phase I results for PBT2 had no discernible effect on share price. The results of the first Phase IIa trial of PBT2 for Alzheimers sent the share price up by about 50% for a day or two, after which it settled back down to where it had been before the results were announced. The results of the first Phase IIa trial of PBT2 for Huntington's (Reach2HD) caused the price to drop by about 30%, although it made up for most of this loss during the subsequent run-up in anticipation of the second Phase IIa trial of PBT2 for Alzheimer's (IMAGINE). The IMAGINE results caused the share price to drop by about 80%.

    Hope springs eternal, and a few of the true believers are always confident that the next clinical result will send the share price "to the moon" and keep it there. But bear in mind that Prana has yet to announce a new clinical trial. The only clinical results we can expect in 2015 are the results for the IMAGINE extension. There's a slight chance we might see a Phase I results for PBT434 this year. The chances of seeing results of a new Phase IIa or Phase II or Phase III trial in 2015 are zero. For that matter, given that any such trial will probably involve 12 months of dosing, the chances of seeing results in 2016 are probably very close to zero. So bear in mind that, aside from the IMAGINE extension, were unlikely to see anything beyond a Phase I result for at least two years.

    Sentiment: Hold

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