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Apco Oil & Gas International Inc. Message Board

goutah3006 62 posts  |  Last Activity: 14 hours ago Member since: Nov 29, 2004
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  • I guess the report I read was a preliminary report from a couple of weeks ago, posted on the ASX website. It included financials but not the detailed statements about the company's drug program. The financials are, of course, disappointing (as in they're burning cash and they'll almost certainly have to do some horribly dilutive financing if they wish to stay in business), but I was pleasantly surprised by the content of the final version that was released yesterday. It appears that some of the cash they're burning is going toward active measures to get the clinical hold lifted and to pave the way for a Phase I of PBT434 (in 2016, instead of the 2015 as promised earlier, but hey, this is Prana). There was also a reference to some sort of writeup on the IMAGINE extension trial. I'm not holding my breath, but at least Prana hasn't forgotten that they performed and extension trial. So perhaps this penny stock is worth holding on to a while longer for entertainment purposes.

    Sentiment: Hold

  • Reply to

    Annual Report

    by copper725 Aug 26, 2015 8:15 AM
    goutah3006 goutah3006 Aug 26, 2015 10:57 AM Flag

    I did a brief analysis of the financials in the annual report shortly after it came out, and posted it here. The Prana true-believers ignored it, but one cannot ignore financial reality indefinitely. Reality has a way of catching up with people who try to ignore it. Based on the company's financials, it seems highly unlikely that Prana will be able to do further clinical efficacy trials unless Big Pharma rides to the rescue. But Big Pharma has had many years to ride to Prana's rescue and has thus far refrained from doing so. Prana has burned a lot of cash since the end of Reach2HD and IMAGINE without producing much in the way of useful results. I'm still waiting for the extension efficacy results, but perhaps those results will never be announced. I'm still waiting for material news on the clinical hold. At the current share price, Prana will have great difficulty raising enough money to proceed with a clinical program. Recall that a few years back Prana had to scrap its planned Phase IIb trial for Alzheimer's because of money problems. And that was during a period when the share price was more than double what it is now and the number of shares outstanding was much smaller than it is now. And the Australian dollar was much stronger then than it is now. Prana may indeed be entering a death-spiral.

    Sentiment: Hold

  • goutah3006 by goutah3006 Aug 25, 2015 2:31 PM Flag

    The good news is that science does not care about Prana's share price. The share price has no bearing on the matter of whether PBT2 is clinically effective. But the share price DOES have a bearing on whether we'll ever determine the clinical efficacy of PBT2. Prana cannot determine clinical efficacy without further trials, which will cost a lot of money. And Prana will have a hard time raising the necessary money unless the share price climbs a lot from its current sub-$1 levels. So, yes, the price is important in that respect.

    Sentiment: Hold

  • If Prana management had in recent months been communicating with the public about the company's status, its current efforts, and its plans for the near-term future, and if I found those communications compelling, I might be tempted to add shares during today's stock-market bloodbath. But, alas, management remains mute on several key issues. So I shall refrain from adding shares. With an investment-grade company, a large and sudden decline in share price may represent a buying opportunity, depending on the company's fundamentals. And an investment-grade company has the resources (financial and otherwise) to survive an extended downturn (of the economy or of its share price or both). Prana does not. The lower the share price goes, the harder it becomes for Prana to raise money. Prana cannot succeed without conducting further clinical trials, and it cannot conduct further clinical trials without raising a lot more money.

    Sentiment: Hold

  • Reply to

    Question for MB

    by marshalg2003 Aug 23, 2015 12:41 AM
    goutah3006 goutah3006 Aug 24, 2015 12:35 AM Flag

    The Aussie TV report in late 2013 was actually confusing two separate trials and treating them as if they were the same trial. One trial was the IMAGINE trial of PBT2, for which Mr. Lawler was a patient. The other was a proposed retrial of a different drug by a big company (I forget which). The report did not give any indication that Mr. Lawler was involved in the other trial.

    Sentiment: Hold

  • goutah3006 by goutah3006 Aug 23, 2015 12:21 AM Flag

    Normally, with an investment-grade company, if the stock price plummets for no particular reason and gets well below my estimate of what the company is worth as a business, I buy or add shares. But because Prana is purely speculative (i.e. it's not an investment), the recent price drop does not induce me to add shares. A while back I thought that Prana might actually have a value of around $3 to $4 per share, but that was when the prospect of a Phase III HD trial appeared both likely and imminent. But I no longer hold this view. The good news is that if the stock market continues its decline for a while, a number of investment-grade companies might drop into value territory.

    Sentiment: Hold

  • Reply to

    To put in context this drop-- compare to 2012

    by enigmatic6088 Aug 21, 2015 11:27 AM
    goutah3006 goutah3006 Aug 21, 2015 2:50 PM Flag

    An occasional tidbit of material information from Prana would indeed be nice. Right now I'd like to know:

    (a) When will we see the efficacy results from the IMAGINE extension trial?

    (b) What is being done to address the clinical hold? And don't just say "we are continuing to work with the FDA".

    (c) Have you designed a Phase III trial for HD, and how much will such a trial cost?

    Sentiment: Hold

  • Reply to

    Why?

    by copper725 Aug 19, 2015 5:02 PM
    goutah3006 goutah3006 Aug 20, 2015 12:59 PM Flag

    Copper asks some simple big-picture questions that everyone here ought to ponder. Prana has had its share of bad luck, but this bad luck has been aided and abetted and compounded by poor management in my opinion. A year ago I was holding my shares because I thought there was a pretty good chance that we'd be in a Phase III trial of PBT2 for HD by now and could perhaps expect to see results in the summer of 2016. And also because I thought the IMAGINE efficacy extension results might be interesting and compelling. But we're still nowhere close to a Phase III and we still haven't seen the efficacy results for the extension. I've pretty much lost interest in the Phase III but remain interested in the efficacy extension results, which are now nearly two months overdue (or five months based on the original timeframe published by Prana).

    Sentiment: Hold

  • goutah3006 by goutah3006 Aug 19, 2015 12:12 PM Flag

    The efficacy results of the IMAGINE extension trial were originally due out by March 31, 2015. Prana announced that there were some delays and pushed the date out to June 30th, 2015. That was seven weeks ago. We still have not seen the efficacy results for the IMAGINE extension. Nor has Prana provided any clue as to when we might expect to see those results, nor have they provided an explanation for the additional delay. This, coupled with Prana's lack of transparency regarding the clinical hold, brings my opinion of Mr. Kempler to a new low. The good news is that science doesn't care about Mr. Kempler's incompetence. So perhaps the extension results will be really interesting and compelling. Or not. There's no way to know until we see the results. And we don't even know whether we'll ever see them.

    Sentiment: Hold

  • Reply to

    Clinical Hold

    by goutah3006 Aug 10, 2015 10:40 PM
    goutah3006 goutah3006 Aug 11, 2015 11:10 AM Flag

    For all intents and purposes, this is a full clinical hold, because the dosages permitted under this hold are too low to be of any use in a clinical trial. So the option of doing a clinical trial during the hold is not a viable option because it would just be a waste of money. But the initiation of the hold was probably just a run of the mill bureaucratic move typical of federal bureaucracies.

    Sentiment: Hold

  • goutah3006 by goutah3006 Aug 10, 2015 10:40 PM Flag

    The U.S. federal government is notoriously slow and incompetent about most things. I wouldn't be surprised if the clinical hold on PBT2 was introduced by some bureaucrat who had nothing better to do. I don't know whether this was the case, but it wouldn't surprise me if it were. I've had dealings with federal agencies and have concluded that dealing with the federal bureaucracy is, as President John F. Kennedy observed more than half a century ago, akin to dealing with a foreign power. The point of my rant is that the clinical hold almost certainly has no merit, and even if Prana is cooperating with the FDA to the greatest extent possible, there's no way to know how long the hold will last. I might get lifted tomorrow. Or it might not get lifted for a year.

    Sentiment: Hold

  • Reply to

    Quarterly report for quarter ended June 30 2015.

    by copper725 Aug 9, 2015 8:50 PM
    goutah3006 goutah3006 Aug 10, 2015 12:53 AM Flag

    You're right that people should take time to read the report to make a realistic assessment of the company's cash-burn trends. Also bear in mind that the exchange rate makes it more expensive to do clinical trials in the U.S., which is where the company appears to be planning to do its Phase III for Huntington's if the clinical hold gets lifted.

    Sentiment: Hold

  • Reply to

    PRAN is NOT Giving up on AD

    by ambo_988 Jul 25, 2015 11:37 PM
    goutah3006 goutah3006 Aug 8, 2015 3:19 PM Flag

    You're quoting a press release from the spring of 2014. A bit stale at this point. Mr. Kempler may be commended for saying that Prana is not deterred from pursuing PBT2 for Alzheimer's but his statement is irrelevant at this point. Prana is in fact very much deterred from continuing its Alzheimers program. Prana is deterred by two things: a lack of funds for further Alzheimer's clinical research, and the ongoing FDA clinical hold on PBT2. Also, the ongoing delay in releasing the efficacy results of the extension trial certainly isn't helping things. I just got back from a week in the wilderness, only to find Prana still trading at about $1, and no news on the efficacy results, and no news on the clinical hold.

    Sentiment: Hold

  • Reply to

    Renewed Open Invitation

    by interesting2me Jul 31, 2015 12:24 PM
    goutah3006 goutah3006 Aug 2, 2015 11:55 AM Flag

    If you read my post carefully, you'll notice that I didn't say that Prana's science is incapable of producing useful drugs. I said that Prana has not yet persuaded the biotech community and the investment community that its science is capable of producing useful drugs. Unless or until Prana persuades the biotech community of this, all discussion about the future of Prana's science is largely moot because Prana won't have the money to pursue that science. The only thing that will persuade the biotech community and the investment community that Prana's science is capable of producing useful drugs will be compelling clinical results. The last set of compelling clinical results was released in early 2008, but those results weren't compelling enough to catch people's interest. We've seen tons of pre-clinical results since that time, but those results haven't helped Prana raise money. And the results of the two clinical trials released in 2014, between them, caused the share price to drop catastrophically, so those results can't be considered compelling.

    Sentiment: Hold

  • Although I remain disappointed that Prana has not yet released the efficacy results for the extension trial (results that were originally promised for the first quarter or CY 2015), and I don't know whether those results will ever be released, I remain excited to see those results. I have no idea what they will be, but I think there's a possibility that they'll show something that nobody was expecting. Expectations for these results seem, at best, muted. Some of the Prana pumpers who were absolutely certain that the main IMAGINE results (which were disastrously bad) would be really, really good seem to believe that the extension results will be uninteresting. But all clinical results are unpredictable. Which is why we have clinical trials. The extension results may be as disappointing as the other recent results, but we won't know until we see them.

    Sentiment: Hold

  • Reply to

    Renewed Open Invitation

    by interesting2me Jul 31, 2015 12:24 PM
    goutah3006 goutah3006 Jul 31, 2015 1:00 PM Flag

    The only relevant question at this point is whether Prana has been able to convince the biotech community and the financial community that Prana's science has a good chance of producing effective pharmaceutical products. The obvious answer is: "no". Unless this changes, discussions about Prana's science will become less and less relevant because Prana will have a hard time raising the money needed to generate the kinds of results that will count.

    Sentiment: Hold

  • Reply to

    Current Events

    by copper725 Jul 31, 2015 7:30 AM
    goutah3006 goutah3006 Jul 31, 2015 11:08 AM Flag

    I had forgotten about Dr. Tanzi's petri dish experiment. I'd like to know why we haven't heard anything further about it.

    Sentiment: Hold

  • Reply to

    Open Invitation

    by interesting2me Jul 30, 2015 11:47 AM
    goutah3006 goutah3006 Jul 30, 2015 2:47 PM Flag

    The whole Biogen thing is largely irrelevant. The only relevant things at the moment are: (a) we are still waiting to see the efficacy results of the IMAGINE extension -- results that were originally promised for the first quarter of CY 2015; (b) we are still waiting for some sort of news on #$%$, if anything, Prana is doing to get the FDA's clinical hold lifted, and (c) even if the clinical hold gets lifted, Prana will have to raise at least $30 million (Australian) just to get through the proposed Huntington's Phase III trial.

    Sentiment: Hold

  • goutah3006 by goutah3006 Jul 30, 2015 12:21 PM Flag

    One can never predict the future successfully except by pure chance. So I can't fault Prana management for having not taken advantage of the company's situation in early 2008. But we can fantasize about an alternate past, can we not? During the months before and after the release of the data from the first Phase IIa trial of PBT2 for Alzheimer's (data was released in the first quarter of calendar year 2008), the share price was about $4. Prana, through dilution, could have raised $40 million during that period. I think it was in the $4 range for something like 10 months. Then they could have started a one-year Phase IIb trial in early 2009, with enough patients enrolled to get stat sig results based on cognitive testing. Results would have been released in the summer of 2010. If those results were impressive, financing for Phase III would have been easy to obtain. If FDA had demanded animal to studies, money would have been easily available for that, too. We would likely have seen Phase III results for Alzheimer's by sometime in 2014. If those results were sufficiently good, Prana might have been granted approval to market PBT2 for Alzheimer's in the summer of 2015 and we'd be enjoying a share price in the mid-to-high double digits by now.

    Sentiment: Hold

  • Reply to

    How much money does Prana need?

    by goutah3006 Jul 28, 2015 2:07 PM
    goutah3006 goutah3006 Jul 29, 2015 6:54 PM Flag

    I willing to entertain any arguments about my estimates. These are in Australian dollars:

    Prana spent $3.5 million on R&D last quarter, which I suspect may have included animal studies and other non-clinical stuff. I model them as spending at half this rate on non-clinical R&D for the next two years, or $1.75 million per quarter ($7 million per year). If anyone expects them to spend less than this, I'd be interested in hearing that person's reasoning.

    Prana traditionally spends between $5.5 and $6 million for non-R&D operations (i.e. salaries, keeping the lights turned on, marketing, etc.). I don't envision any reason for this to change. To keep the pumpers happy, I'll switch to the lower number for modeling purposes.

    $41 million (= $30 million U.S.) seems like a reasonable cost to expect for a Phase III trial with orphan status.

    Add 'em up: $41 million for the trial plus $14 million for non-clinical R&D over a two-year period plus $11 million to general operating expenses over a two-year period, and you get $65 million between June 30 2015 and June 30 2017. So they'd need to raise about $30 million under this model.

    Sentiment: Hold

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