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Elan Corporation, plc Message Board

aknb9 16 posts  |  Last Activity: Apr 11, 2014 11:57 AM Member since: Feb 23, 2005
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  • Reply to

    Moving back to Buy

    by goutah3006 Apr 11, 2014 10:33 AM
    aknb9 aknb9 Apr 11, 2014 11:57 AM Flag

    I don't want to single anyone out but -
    Contrary to what many people here are saying the cognitive endpoint was in fact one of the most important (if not most important) endpoint in the trial. If PBT2 worked as advertised, most of us and the company expected at least a trend toward cognitive improvement in a trial of this duration. No matter how anyone wants to spin it the fact that there was no cognitive improvement was a huge disappointment for all parties involved in the trial. The company can make all the excuses they want (and some of them have validity) but we all expected to see some cognitive improvement.
    The selloff is not at all an over reaction. The most important trial in the history of the company was a failure. The last three trials all had issues. The first PBT2 trial needed a reanalysis of the data, the HD trial had a major data issue that delayed the results, and the Imagine trial was confounded by data in a placebo group that contradicts everything we think we know about amyloid and Alzheimer's.
    The stock deserved the sell off and it is in no way overdone IMO.

  • Reply to

    Moving back to Buy

    by goutah3006 Apr 11, 2014 10:33 AM
    aknb9 aknb9 Apr 11, 2014 10:47 AM Flag

    I think it is foolish to buy a stock that is trading lower highs and lower lows on a daily basis. You should wait
    until it bottoms out. The dump was probably exacerbated by the market but inevitable.

  • Reply to

    Tanzi Should Be Barred

    by jmlregoog Apr 4, 2014 1:21 PM
    aknb9 aknb9 Apr 5, 2014 8:29 AM Flag

    I could be wrong but I believe Tanzi, Kempler, and everyone else that was representing the company expected this trial to hit not only on the primary endpoint but some secondary ones as well. The fact that the amyloid results were somehow discombobulated is immaterial. They all expected to see some positive stuff in cognition. If lowering the amyloid does not result in improvements in cognition than this drug is probably useless.
    The drug was designed to lower amyloid. We now know that lowering the amyloid is does not result in cognitive change. The science and knowledge base has evolved since they designed this drug. I think the drug has some effect via the effect on metals in the brain and might be useful given earlier in the course of the disease.
    We are highly unlikely to find out. They are designing drugs based on the latest discoveries as we speak.
    It is a mistake for investors to accept the obligatory explanations offered up by the parties involved for why their trial failed.

    Andy

  • Reply to

    Tanzi Should Be Barred

    by jmlregoog Apr 4, 2014 1:21 PM
    aknb9 aknb9 Apr 4, 2014 7:09 PM Flag

    Matt - I agree that the Tanzi bashing is overdone and unwarranted. I think he sincerely believes PBT2 might show statistical significance in a proper trial with hundreds of patients.
    The fact is despite the fact the amyloid results were mucked is almost irrelevant. There was no top line improvement in cognition and that is what everyone was looking for. The fact the drug had an effect on atrophy is nice but this also had no effect on cognition.
    I have not seen anything from the company indicating they are interested in testing the drug at higher doses.
    The trial was intended to attract a partner. The odds of that happening are considerably worse in light of these results.
    Regards,
    Andy

  • Reply to

    I removed my prior post

    by aknb9 Apr 3, 2014 10:17 AM
    aknb9 aknb9 Apr 4, 2014 8:44 AM Flag

    Quote: The other big question is whether the drug is being trialed at an effective dose. I wish is was clearer to me why they keep sticking with the 250 mg dose when the safety issues seem to be settled. Why not 500, 750 or 1000 mg?

    I did not want to comment on this without listening to the whole presentation so I went back and listened to the question and answer part of the conference call this morning.
    There was no reference to increasing the dosage in the Imagine results conference call. To my knowledge the company is not interested in exploring higher dosages. It appears the theory that an increased dosage might lead to greater efficacy and that future trials might explore higher dosages originated on the message boards has no basis in fact.
    The purpose of this trial was primarily to attract a partner for a larger fully-powered trial. The trial did not meet any of it's primary or secondary end points other than continuing to display nice safety and tolerability. There was no top-line data indicating any improvements in cognition or memory in the trial. This was a really tiny trial so I don't expect there will be much in the way of subanalysis. It is probably safe to assume one can stick a fork in the possibility of a larger pharmaceutical company funding future trials of PBT2 for Alzheimer's.
    I think the company might be best served curtailing the Alzheimer's indication altogether. I don't believe there was sufficient efficacy in the HD trial to warrant future trials in that indication either.
    They have 25M and two leaders in the field advising them. Perhaps they should take a serious look at reinventing this outfit.

    Andy

  • Apparently my attempt at gallows humor fell short.
    I just listened to the recent conference call on the Imagine trial. I was putting it off because I thought it would just be depressing but it was kinda entertaining.
    Prof Shoulson begins his comments by distancing himself from the trial. He essentially said he had nothing to do with the trial. He went on to say the most important finding was that the drug continues to display safety and tolerability.
    Prof Tanzi's comments were most interesting. He agreed with Prof Shoulson that the most important results were the great safety and tolerability. Apparently, he and I did the same thing regarding the puzzling amyloid data. We both attempted to find a previous trial where the amyloid decreased in a placebo group of Alzheimer's patients and we both came up empty. He also made a comment regarding the trend towards a reduction in brain atrophy that was exactly what I was thinking. The clinical significance of the reduction in brain atrophy was questionable in that it was not accompanied by any improvement in cognition or memory.
    Mr Kempler did his best to spin the mediocre data but was utterly unconvincing. They essentially blamed much of the failure on the small sample size and flawed trial design. Items previously discussed here.
    The best part of the interview for me was was when Mr Kempler recounted Prof Shoulson telling him some years ago that not everything that is statistically significant is clinically meaningful and conversely not everything that is clinically meaningful is statistically significant.

    Andy

  • Reply to

    I now believe the Imagine trial was a success

    by aknb9 Apr 3, 2014 8:37 AM
    aknb9 aknb9 Apr 3, 2014 10:12 AM Flag

    I removed my prior post. Apparently my attempt at gallows humor fell short.
    I just listened to the recent conference call on the Imagine trial. I was putting it off because I thought it would just be depressing but it was kinda entertaining.
    Prof Shoulson begins his comments by distancing himself from the trial. He essentially said he had nothing to do with the trial. He went on to say the most important finding was that the drug continues to display safety and tolerability.
    Prof Tanzi's comments were most interesting. He agreed with Prof Shoulson that the most important results were the great safety and tolerability. Apparently, he and I did the same thing regarding the puzzling amyloid data. We both attempted to find a previous trial where the amyloid decreased in a placebo group of Alzheimer's patients and we both came up empty. He also made a comment regarding the trend towards a reduction in brain atrophy that was exactly what I was thinking. The clinical significance of the reduction in brain atrophy was questionable in that it was not accompanied by any improvement in cognition or memory.
    Mr Kempler did his best to spin the mediocre data but was utterly unconvincing. They essentially blamed much of the failure on the small sample size and flawed trial design. Items previously discussed here.
    The best part of the interview for me was was when Mr Kempler recounted Prof Shoulson telling him some years ago that not everything that is statistically significant is clinically meaningful and conversely not everything that is clinically meaningful is statistically significant.

    Andy

  • Reply to

    Progressing with HD trial

    by kadaicher1 Apr 2, 2014 1:13 PM
    aknb9 aknb9 Apr 2, 2014 8:04 PM Flag

    Kad - What I am saying is I don't believe know if PBT2 is more effective than the B vitamins yet. I would hope you would agree the top line Imagine results on cognition were a
    disappointment. I certainly expected to at the very minimum hear there were positive
    trends. I don't know about you. I was very disappointed. I don't think it's over. It might be on life support if the FDA gives them a cold soldier on HD.

  • Reply to

    Progressing with HD trial

    by kadaicher1 Apr 2, 2014 1:13 PM
    aknb9 aknb9 Apr 2, 2014 2:13 PM Flag

    It wasn't a tiny underpowered trial for most of the longs here till it failed.

    "A drug that could stop my brain wasting away, I think I would want that."
    B vitamins have a demonstrated positive effect on brain atrophy.
    You can take them now.

    I really wish the Imagine trial was successful and we were having a different conversation.

  • aknb9 aknb9 Apr 2, 2014 10:04 AM Flag

    You are probably just inexperienced. Most of the people buying the stock don't have any experience with biotech. This was not an interim look. This was a 52 week trial. The trial failed and the company has 25M to burn. What would you expect them to say?
    GL

  • aknb9 aknb9 Apr 2, 2014 9:56 AM Flag

    Over-react? Did you read the release?
    Prana's PBT2 did not meet its primary endpoint of a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer's disease patients...
    No improvement was observed on the secondary endpoints of brain metabolic activity, cognition and function....
    The fine print is meaningless.

  • Reply to

    What is there to do? Any advice for people?

    by mikehillhams Mar 31, 2014 7:51 AM
    aknb9 aknb9 Apr 2, 2014 8:30 AM Flag

    Mike - The bottom line is you really can't expect to get great advice on PRAN on a Yahoo message board - two days after the fact. If this was Monday, I would have told you to sell and move on. Now the stock is unpredictable. People are still reacting to a most disappointing trial and the stock could go up on purely technical considerations. I expect it to go down but run-downs are harder to play than run-ups.
    There are no fundamental reasons to be in this stock right now.
    Regards,
    Andy

  • Reply to

    WHY PRAN IS A BUY NOW !!

    by ernestopascale Apr 2, 2014 6:39 AM
    aknb9 aknb9 Apr 2, 2014 7:33 AM Flag

    1) "the failure to reach the end point can be related to a problem of dosage" - We haven't seen the data yet. This was a longer trial than the previous ones. One would expect to see better results over time on cognition if the drug was effective. Appears the results were worse.
    2) The company, back on February 18, reported ITS That it met primary endpoint in Phase II studie
    REACH2HD for treating Huntington's Disease. - The primary endpoint of the HD trial was safety and tolerability. There was only a ‘significant’ difference on one of the eight tests. According to the unpublished results the drug helped people connect letters and numbers with a pencil against a clock. None of the other 8 tests was better in drug-treated volunteers. Not very exciting results.
    3) That Zavoico estimates Valuing Prana Solely on the successful development of PBT2 for Huntington's Disease gives the stock a current value of $ 3 and a one-year price target of $ 5 - Zavoico isn't exactly batting 100 here. That is a ridiculous reason to invest .
    4) Prana's market cap is $ 99 million after the drop. The Australian company's 2013 year-end in June Showed $ 12,217 million in assets (June 30) with almost no debt - I believe they stated they have 25M in cash. With no drugs with proven efficacy in the pipeline that is what they are currently worth. I expect they will burn through that doing more tiny trials, underpowered to show much.

  • aknb9 aknb9 Mar 28, 2014 9:40 AM Flag

    I post information pertinent to stocks I own or follow regardless of their positive or negative implications.
    The purpose of these message boards is (ideally) to share information and opinions.
    Unfortunately some stock holders never want anything that might be interpreted as negative to be posted.
    This only serves to reinforce a closed mindset to material information on an investment.
    Andy

  • Reply to

    With a heavy heart

    by peteharmisan Mar 26, 2014 7:42 PM
    aknb9 aknb9 Mar 26, 2014 10:44 PM Flag

    "I sold today. Not because I think any less of PRAN's success, but because of my availability to monitor the stock."
    That's one of the funniest things I ever read on a Yahoo message board. Thanks for the laugh.

  • I sold most of my stock today. I was not going to risk a significant amount of my profit when the results are due anytime now. I held onto some shares just in case the results are better than expected or it goes up next week. This was a great trade for me regardless of what happens going forward.
    My apologies to this message board. I had no idea I was going to be stalked by what appears to be a Chinese guy from the ARIA message board.
    GLTA (except the creepy shorts)
    Andy

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