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ImmunoCellular Therapeutics, Ltd. Message Board

  • arodbronx arodbronx Nov 7, 2013 6:42 AM Flag

    Zero Chance ICT-107 Does Not Advance

    I don't see any chance this drug does not move forward. If it had no effect on survival, the 64 events would have already happened and we would have the results. Worse case I see is a survival benefit, but not nine months. And according to Yu last night, a two month benefit (the same that got TMZ approved), would be enough to move it to Phase III.

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    • I have to agree. Even without a survival benefit (which would be statistically unlikely based on previous results and how the trial is going now) this would be approved based on the limited side effects alone. Say your choice is either: (a) IV chemo regimen with nausea, vomiting, and risk of infections or (b) vaccine injection whose only side effect is mild rash wouldnt you strongly prefer the vaccine. FDA knows this and is lowers hospital costs from less side effects (which they probably care about even more).

      Sentiment: Strong Buy

    • I reread IMUC manager 1q 2013's presantation regarding ICT-107 P2: Status and Results:
      . 278 patients enrolled by Sep. 2012: 124 randomized
      . Interim analysis for safety and futility estimated to begin in 1Q2013;DMC recommendation anticipated 2Q2013
      - Timing is event driven
      - A good result is DMC recommendation to continue the trial
      . Fisrt top-line results estimated for year-end 2013
      (will be continued)

    • zero chance with a six month benefit it does not get immediate approval

      this is essentially a 10 bagger when you have topline in march or may 2014

    • Dont say "never" you're going to jinx us. there is always something out there that's unexpected and could hit shareholders. Look at AFFY as a popular example, everybody thought it was fine. . then.

    • rqtect Nov 8, 2013 11:06 AM Flag

      Yes I agree third phase is a given. but has that been priced in? I don't think so but just asking. Will it pass the third phase that is the real question? I think it will based on what I heard and understand. I think if the FDA has any clue it will pass.

    • and why is it that you believe that is indeed not the case? go back an listen to the previous conf call.

      good chance you are mistacken.

    • Not saying whether i agree or disagree with your post but i want you to remember this post so when this stock dives on zero news i want you to recognize an opportunity and don't panic.

    • I really am mistified by their reluctance to say weather they will have prior knowledge of the 64th event before final analysis. That is a simple question and important to investers. Whenever the 64th event happens it would seem to me that prior knowledge would give insiders a very significant advantage for making decisions on this stock. Huge difference from keeping something secret for three days or four months. Also big difference if you know the 64th event happened in September or January!!! I just don't get it, my opinion is they will have prior knowledge but won't say, and I don't like it!

      Sentiment: Buy

      • 6 Replies to periclesandathens
      • Everyone in these trials already knows if the vaccine is going is be approved or not. They may not have the exact death total in yet, but every single patient should be dead or have recurrence by now (actually a while ago) if ICT-107 was not working.

      • They will know when "64" occurs. They need/want the extra time to analyze the results for the proper spin rather that release raw data for rampant public speculation. You know, the public - all the potential Goldbergs out there...

        Sentiment: Buy

      • What I took away from the company's stance on release of the top-line data was basically they wanted to take the attention away from a negative, someone or -one's death, and make it about the numbers. They in turn acknowledged rightly that a a short timeframe needed to get on top of what the data (a rough analysis) was saying and draw the major conclusions before going public.

        They will not have knowledge of the 64th event before FINAL analysis. According to CEO this will require additional weeks and months and plan to use the lag time between notifying the FDA and the actual meeting for detailed analysis.

        Sentiment: Strong Buy

      • I agree with metryguy101, timing is definitely not the only factor in determining efficacy for this drug. I am assuming that on the 64th event, they will then be unblinded and have to start gathering all of the data from all the different sites...that can take time. Once they have the medical records and can reduce them into meaningful data, it will not take long to do the actual analysis.

      • Insiders are prohibited by SEC rules from trading the stock if they have material information not available to the public. Additionally, while important, the timing of the event alone is not the sole determining factor that will determine the future of this drug.

        Sentiment: Strong Buy

      • you really should go over your spelling. this looks greek to me

    • Anything below 6 months benefit should be considered a failure. We need a succes (9 months or more) to finance phase 3 with minimal dilution.

      I was a bit disappointed that there wasn t any discussion on the possibility of accelerated approval. With the results of phase 1 and the 2 months benefit of the only approved drug, they should demonstrate more confidence. Anyone thoughs on this matter?

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