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ImmunoCellular Therapeutics, Ltd. Message Board

  • discoduck33 discoduck33 Jul 31, 2013 8:31 PM Flag

    Nick - the question you should ask

    If it really bothers you that we keep getting told Q4 2013 when we expect results later, I know what you can ask IR if you want a truthful answer and I thought that now would be a decent time for me to share that question with you.

    Ask them if they deviated from the Q4 2013 date, would that basically be admitting publicly that they believe the efficacy to be greater than 9 months? Ask them if they even reasonably can deviate from that date, or would the public deviation from that date basically be commenting that the vaccine works while it is still in trial, which is basically illegal. In other words, don't ask to tell you something that they are not at liberty to say. Ask them if they believe that it would be unprofessional to provide any other answer, even if the date is perhaps not the most likely date, simply because one should not state that they are convinced that a vaccine is working while it is in trial. (because we are partnering with the FDA and working together to find the answer, and that saying some date other than date that was discussed prior to enrollment would be a disservice to that mission)

    In other words, what you are asking is a question about ethics. Get it? You can't mislead someone about an ethical question without being unethical. If your hypothesis is that we can't say any other date other than the one we are saying because of ethical reasons, shouldn't your question be an ethical question, rather than a mathematical one?

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    • Honestly I would just ask them why they are maintaining the same end date when the dsmb peak happened much later than originally expected - this is a pretty straight forward question that should be able to be answered without causing any issues or conflicts of interest.

      • 3 Replies to phishes3
      • Well, the original published end date was OCT with Anaylsis being complete by Dec. That's still the official document so I assume they have to stick with that until that date is passed or until the committee says otherwise?

      • The problem with that is that the question corners them rather than providing catharsis. One cannot state, "Dude, that is the only date I can give you, because that is the only date I am legally permitted to provide," without basically saying that they agree that is not the proper date. The way I ask the question, you are asking if an ethical person should provide any other date other than the date they provided, while in trial, if they suspected that it was more likely that the date should come later. If you say that you modeled a 9 month survival advantage with an 80% power based on 64 events happening by the end of this year, wouldn't wavering from that basically publicly state that you believe the vaccine is working while it is in trial no less. They will never mislead any ethical question that is purely ethical in nature. The answer is:

        a) If something thinks that 64 events is most likely to come later, they should say it. They should feel free to advertize a vaccine while it is still in trial. If they think that their vaccine should be approved following Phase II, they should just say it, and it shouldn't matter whether the vaccine is in trial or not.

        b) If you think that the vaccine is working that is good, but the FDA is our partners. This company, along with many others place trust in the process when we partake in a trial like this. It is very important to place trust in those that have the results unblinded to them so that they can make the best call possible for public health without any pressure. Publicly stating that one perceives that 64 events will come later than the agreed upon efficacy date basically undermines that trust, and no good can come of it.

        Neither of these two answers provides any statement, inferred or explicit, regarding their thoughts on the current efficacy. All it does is provide an important moral clarification between right and wrong, something which some people don't seem to understand.

      • OK - I sent a question to IR - I will let you know the response when I hear back from them.

 
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