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Prana Biotechnology Limited Message Board

  • godfrey126 godfrey126 Feb 8, 2013 4:08 PM Flag

    Unblinding trial early

    One reasone i keep giving myself to stay in right now instead of getting out now and getting back in at later date is the possibilty of the trial being sos successful it owuld be unethical to continue to treat with placebo. Ive seen this before in medical trials. Where the trial has to bestopped early and unblinded because agroup is responding so dramtically to the treatment arm and it would be unethical to continue withhold active meds to the other trial participants this would be great news but could leave some lurkers in the cold any thoughts to this possibly happenning

    Sentiment: Hold

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    • Anything is possible, but the most likely scenario is that there will be no unblinding of either trial and there will be no deal with Big Pharma prior to the release of results from the two trials. The release of results for the HD trial will probably happen no sooner than the third quarter of this year, and the release of results for the AD trial will probably happen no sooner than the first quarter of next year. The researchers in charge of each trial will prepare a report and give it to Prana, prior to which Prana management will have no clue as to the nature of the results. Prana will probably hold on to the results just long enough to prepare a press release (to brag about the results if they're really impressive, or to spin the results if they're not so impressive). So there might be a delay of a few hours or maybe a day or two between Prana's receiving the results and Prana's announcing them to the world.

      Other scenarios might happen, but I wouldn't count on it. Wishful thinking is counterproductive in the world of stock speculation.

      Sentiment: Buy

      • 2 Replies to goutah3006
      • Rather than wishful thinking, considering the various possibilities, knowing that the future can hold any of the outcomes, means being personally comfortable for any eventuality. In this case, regardless of what happens, I consider this is a "hold" or "accumulate" situation going into the trial results. Partnership occurs - great. Unblinding occurs due to efficacy - great. Doesn't happen - no problemo. Point is, makes no difference what happens in terms of my stock position at this time. Other biotechs I have take up much more time dancing in/out on speculative positions.

        Sentiment: Strong Buy

      • that would be "Wishful thinking is PRODUCTIVE in the world of stock SPECULATION. Not so much in stock INVESTMENT."

    • I am compelled to add to your point, that it would be unethical to discontinue treatment post-trial if the results were clearly dramatic. Trial designs have been modified and submitted for FDA approval to permit a move directly into ph3, expanding the trial size and patient profiles, defining ph3 endpoints, etc. IF they unblinded now based on efficacy, one would hope they would be prepared to move into ph3 reasonably soon. Only outside financing would permit that. Secondly, early unblinding of trials has been most often considered in terminal diseases when the treatment was found effective at end-stage to prolong life. But while the Prana trials involve early stage HD and AD, both terminal diseases, the ethical considerations do hold significant weight.

      Sentiment: Strong Buy

    • The greater possibility at this point in time would be a partnership jumping in to acquire geographically defined licensing with milestone payments applied to the ph2 results and underwriting ph3, NDA, etc. . . or some similar arrangement. Timing for this may be approaching, since the scheduled released of positive ph2 results on HD, AD, or both would then attract a herd of drooling pharmas, with none assured of getting in on part of a potential blockbuster - and to the benefit of Prana and shareholders. Then again, if there are negative ph2 results leaving now would be retrospective genius. IMHO, it is the opposite.

      Sentiment: Strong Buy

    • "The first patient has already completed the 6 month treatment period and no patients have withdrawn from the trial for any safety or other reasons, so we are very pleased with our progress to date. The Data Safety Monitoring Board will report again next February," said Mr Kempler, Prana's Chairman and CEO.

      That is a snip it from a PR released in November regarding the Huntington Disease Trial. So we might get some news this month. Odds are the Board will just say that PBT2 us safe and you can continue with the trail. But any news is good news.

      • 1 Reply to cheddaman45
      • its not odd at all that they announced safety -
        a) its a primary goal of the trial: safety and tolerability
        b) other drugs in trials have caused brain swelling and other side effects that even when not fatal, caused dropouts. So to reach this level of testing without dropouts is important data, not odd.

        Sentiment: Strong Buy

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