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Mesa Laboratories Inc. Message Board

goutah3006 228 posts  |  Last Activity: 8 hours ago Member since: Nov 29, 2004
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  • Reply to

    Three Questions

    by goutah3006 12 hours ago
    goutah3006 goutah3006 8 hours ago Flag

    In addition, I'm seeing a lot of hope being posted here. Hope that Big Pharma will ride to the rescue. Hope that the FDA will waive away further clinical requirements to get PBT2 approved. Hope that a news announcement will boost the share price enough to enable Prana to raise a lot more money. Hope that the IMAGINE extension will produce great results that will raise the share price a lot. Etc.

    Hope is not a good strategy for either investing or speculating. Long-term Prana shareholders have been subsisting on hope for many years now, and have had their hopes repeatedly dashed.

    I'm operating on a no-hope basis (not to be confused with a hopeless basis). Prana has about $41 million right now. I'm assuming they'll be able to raise perhaps another $20 million over the next couple of years. Under this assumption, we're looking at a budget of $60 million and a time frame of two years to get PBT2 approved for Huntington's. So my question is this: Is $60 million enough?

    Sentiment: Buy

  • Reply to

    Three Questions

    by goutah3006 12 hours ago
    goutah3006 goutah3006 8 hours ago Flag

    I appreciate the comments in this thread. Good food for thought. However, I'm still not seeing a number indicating how much it might cost us to bring PBT2 to market for Huntington's. Will it cost $50 million? Will it cost $100 million? Will it cost $150 million? Will it cost $20 million? I'd like to see a number, along with some facts to substantiate that number. Given the diverse talent on this message board, I suspect that someone out there could put together an estimate. I'll work on it myself over the coming week, but I assumed that somebody out there might have already done so.

    Sentiment: Buy

  • Reply to

    Three Questions

    by goutah3006 12 hours ago
    goutah3006 goutah3006 11 hours ago Flag

    Well, that's an interesting possibility. But I assume that even with a fast track, additional clinical testing would be required above and beyond the Reach2HD trial. Perhaps a Phase IIb with a one-year study time and 200 patients. How much would that cost?

    Really, the bottom line I'm trying to get to with my questions is this: What is the minimum amount of money with which Prana could get PBT2 approved for HD (assuming that PBT2 turns out to have efficacy for HD)? If the number (including the amount needed to keep the lights on) works out to around $50 million, then we're probably in good shape. If it's closer to $100 million, then we may be in trouble. Counting on Big Pharma to ride to the rescue is not a good strategy. Big Pharma isn't likely to partner with Prana unless Prana can demonstrate some serious efficacy for PBT2. And such a demonstration will require additional clinical trials.

    Sentiment: Buy

  • Reply to

    Three Questions

    by goutah3006 12 hours ago
    goutah3006 goutah3006 11 hours ago Flag

    These three questions are not rhetorical. I'm looking for serious answers, because the answers to these questions will give us a better feel for Prana's prospects going forward. If we can go straight to a Phase III Huntington's trial using a larger dosage, and if the trial is large enough to be powered to detect what we want to detect, and if such a trial can be conducted for $30 million, then we're in great shape. This would leave the company with enough cash to keep the lights on for a couple of years while the trial is being planned, conducted, and analyzed. If, on the other hand, we need to do a new Phase IIa to assess safety in Huntington's patients for a larger dose, and/or we need to do a $80 million Phase III instead of a $30 million Phase III, then we're in trouble. Recall that Prana planned a Phase IIb trial of PBT2 for Alzheimer's that would have cost about $26 million, but was unable to obtain funding for this trial. We suffered through years of zero progress due to this lack of funding. The Phase IIb plan was eventually abandoned, and was replaced by the more modest Reach2HD and IMAGINE trials. If the Phase IIb had been conducted, it would probably have been large enough to be powered to detect efficacy, and if efficacy had indeed been detected, we'd right now be nearing the end of a Phase III trial for Alzheimer's. Again, this all boiled down to a lack of money. Ergo, the important nature of my three questions.

    Sentiment: Buy

  • Here are three questions for the clinical-trials experts on this board:

    1 - How large would a Phase III Huntington's trial have to be in order to be powered to detect statistically significant efficacy?

    2 - Once we've established the size of the trial, how much would such a trial cost? I'm assuming it would use the same sorts of tests that were used on patients in the Phase IIa trial, but would expand the brain imaging test to every patient instead of only a handful, in order to rigorously test for hippocampal shrinkage.

    3 - Could a higher dosage of PBT2, such as 500 mg, be tried in a Phase III trial, or would we first need to do another Phase IIa at that dosage to establish safety? I know that the Phase I tested dosages up to 800 mg. But that was on healthy patients.

    Sentiment: Buy

  • Reply to

    Ambulance chasers...

    by rdf780300 Apr 23, 2014 9:43 AM
    goutah3006 goutah3006 Apr 23, 2014 6:28 PM Flag

    These types of lawyers simply look for a stock whose price has plummeted due to bad news, then they announce an investigation in the hope of drumming up a class-action suit. I doubt that these attorneys know much about Prana or its history. And I can't really think of anything unethical that Prana has done. I have a hard time believing that this attempted shakedown will get anywhere. If there were substantial evidence of wrongdoing, there'd be a lot of shyster law firms issuing similar announcements instead of just one.

    Sentiment: Buy

  • Reply to

    This Will Rock When They Release The Plan

    by tb00tb00a Apr 23, 2014 10:56 AM
    goutah3006 goutah3006 Apr 23, 2014 11:43 AM Flag

    Your second post is more in line with my thinking, which is that a $3 or $4 price for the stock given our current knowledge would be pretty reasonable, and the mere announcement of an actual executable plan for an HD trial could bring us to such levels. Which is why I added shares during the recent sub-$2 period. And you're also right that one should consider selling some shares if the stock goes up a lot prior to clinical results. I sold 37% of my shares prior to the IMAGINE results, locking in a healthy net gain on my total Prana speculative venture even with the stock at its current price. The reason I sold some shares during the pre-results period is that I lacked the extreme level of confidence in Prana exhibited by some of the longs here.

    Sentiment: Buy

  • Reply to

    This Will Rock When They Release The Plan

    by tb00tb00a Apr 23, 2014 10:56 AM
    goutah3006 goutah3006 Apr 23, 2014 11:14 AM Flag

    tb wrote: "There' s not much downside from here. The upsides are good news on the HD front (it's coming, only a matter of time), progress on the PD front (it's a sure thing)"

    I disagree. Have we not learned over the past six years that overconfidence is the enemy of successful speculation? There's plenty of downside potential from here. If a larger HD clinical trial is performed and it shows no efficacy, do you really think there would be no negative effect on the share price?

    Yes, the potential for good news on HD represents an upside, but to assert that "it's coming, only a matter of time" is to say that you know for certain that success with HD is "a slam dunk" (to borrow a phrase used several years ago by kadaicher regarding PBT2 and AD). Ditto for the assertion that progress on the PD front is "a sure thing".

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 22, 2014 8:14 PM Flag

    I agree that a partnership is more likely than a buyout. And more desirable, in my view. However, people have been saying that a partnership is just around the corner for more than six years now. No partnership has materialized. I long ago decided that if a partnership happens, we'll know it when we see the press release.

    Sentiment: Buy

  • Reply to

    News pending.

    by goodshek Apr 22, 2014 3:28 PM
    goutah3006 goutah3006 Apr 22, 2014 5:13 PM Flag

    Share price movements are not reliable predictors of future news. When they do predict future news correctly, it's usually by coincidence.

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 22, 2014 3:23 PM Flag

    I haven't heard any buyout rumors, and even if I had I wouldn't believe them. I strongly doubt that Big Pharma has any interest in buying out Prana at this time.

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 22, 2014 11:15 AM Flag

    Prana has had a large library of MPACs for a long time. This won't do them (or us) any good until Prana can actually persuade either Big Pharma or Wall Street or both that at least one of its MPACs has real value as a treatment for something. Thus far, Prana's track record in this regard has been a bust. They've done four Phase IIa trials (one for PBT1 and three for PBT2) and have not yet produced data sufficiently robust to entice Big Pharma into partnering with Prana. The can issue all the PRs they want about new patents or whatever, but, as I've said many times here over the years, clinical trials are all that really count in this business.

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 21, 2014 1:07 PM Flag

    The big question is this: How large a sample size would be needed to ensure that a future clinical trial of PBT2 for Alzheimer's is sufficiently powered to detect any potential cognitive benefits from PBT2?

    Given the expense of PET scans of the sort used to measure amyloid burden, plus the questionability of this method, I would consider doing a study involving perhaps 200 patients and using MRI or CT scanning to measure hippocampal volume, plus doing the same cognitive testing that was done during IMAGINE. Deleting the PET scans would reduce the cost. In other words, re-do IMAGINE but with a greater number of patients and no PET scans.

    Of course, this is merely pie-in-the-sky dreaming at this point. Prana simply doesn't have enough money to do such a trial anytime soon, thanks to the disastrous outcome of the IMAGINE trial.

    Sentiment: Buy

  • Reply to

    Parkinson

    by kingfish543 Apr 17, 2014 10:09 PM
    goutah3006 goutah3006 Apr 18, 2014 11:35 PM Flag

    I believe you're right that the Phase I has been shifted to 2015. I had the impression that Prana planned to self-fund the Phase I, and that the stuff funded by both the MJFF and Parkinson's UK was purely pre-clinical.

    I think that Prana was sort of counting on the results of the IMAGINE trial to boost the share price to the point where the company could easily raise cash for multiple parallel trials (HD, AD, PD). Since that bubble burst, Prana is having to scale back its near-term plans.

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 18, 2014 10:24 AM Flag

    "Be patient and you will be rewarded." Well, I've been patient with Prana for nearly eight years now. My only reward came from selling off about 37% of my shares during the run-up before the recent clinical trial results. This turned out to be a big reward indeed. Multiple hundreds of percent gain, nearly all of which was realized shortly before the results were announced. The shares that I still own are up about 25% from where I bought them. So if I had possessed the absolute faith in Prana that some people here exhibit and had kept all my shares and held them through the results, my reward would have been minuscule.

    Sentiment: Buy

  • Reply to

    Parkinson

    by kingfish543 Apr 17, 2014 10:09 PM
    goutah3006 goutah3006 Apr 18, 2014 10:19 AM Flag

    This will be a Phase I trial of PBT434 on healthy volunteers to assess safety. I don't anticipate a Phase II trial of PBT434 anytime soon, due to Prana's chronic lack of money. I suspect that they'll focus on PBT2 for Huntington's for the time being.

    Sentiment: Buy

  • Reply to

    Was today he dead Cat Bounce day?

    by gyoung28105 Apr 17, 2014 7:16 PM
    goutah3006 goutah3006 Apr 17, 2014 9:09 PM Flag

    Could be. I don't know. But I suspect that we've reached a price that pretty much reflects where we are. I put a speculative value of somewhere between $3 and $4 on Prana right now. But the stench from the disappointing IMAGINE trial results is keeping the share price below $2. That's life. A sub-$2 price right now is perfectly understandable. The stench may start to dissipate if Prana unveils a realistic and aggressive plan for further clinical trials. I'll continue to hold the shares I didn't sell prior to the trial results. If the price gets up to the $3 - $4 ballpark, I'll probably start selling again.

    Sentiment: Buy

  • goutah3006 goutah3006 Apr 17, 2014 6:54 PM Flag

    Prana did the right thing by running both trials, one for HD and one for AD. They rolled the dice on the AD trial and lost big-time, but it was a worthwhile risk. PBT2 was designed for AD, not HD, and to forego doing an AD trial would have been a bad idea. So I don't regret at all that they did the IMAGINE trial. While I'm sad that the IMAGINE trial was such a complete failure in its primary objective (to produce exciting results that would cause money to pour into Prana), we learned a lot of useful stuff from that trial. I suspect that the focus will be on looking for real efficacy in HD and getting PBT2 approved for that ailment. Further AD clinical trials may happen, but probably not anytime soon. If we get good Phase III results for HD, the share price could increase to the point that Prana might be able to raise enough money to resume clinical testing for AD. But it could be a couple of years before we see Phase III results for HD.

    Sentiment: Buy

  • Reply to

    This will be going after early stage HD

    by kadaicher1 Apr 12, 2014 11:42 AM
    goutah3006 goutah3006 Apr 16, 2014 12:18 AM Flag

    I'm open to the possibility that an HD trial will be conducted soon. PBT2 dosages up to 800 mg were shown to be safe in the Phase I. Question: Do they need to do another Phase II if they want to test, say, a 500 mg dosage on HD patients (given that the Phase I was only on healthy people)? Or could they go straight to a Phase III with a 500 mg dose?

    Sentiment: Buy

  • goutah3006 by goutah3006 Apr 15, 2014 6:19 PM Flag

    Why are some people complaining about the share price? If you think that Prana still has a bit of a future, a big price drop like this represents an opportunity to buy more shares for a given amount of money. While our dreams of a $50 share price this year were shattered by the disappointing IMAGINE results, we can realistically dream of a $3 share price this year. If you view this as a $3 - $4 stock as I do, then you can enjoy these price drops. Buying a $3 stock at $1.80 is a lot nicer than buying it at $2.80.

    Sentiment: Buy

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