Saturday, July 16, 2016 10:40:13 AM
Assuming your wife/husband is just diagnosed with GBM, and doc recommends try of DCVax-L;
The company developing DCVax-L, after observing unusually low evening rate of all patients in the trial as a whole, has voluntarily stopped enrolling any new patient candidates some ten months ago because it doesn't want to enroll any patients into the control arm as it is highly likely DCVax-L works;
Yes, it could also turn out that there might be no ss difference between the control and treatment arms (or early and late DCVax-L receiving patients) but the fact is "any patient enrolled in the trial lives longer, much longer than anticipated. This observation is based on updated 20 months or so anticipated median OS for this deadly indication. So to call it unusual, the median OS for the entire trial must be well over 25 months or even higher.
So do you think the company will risk being sued later by you, let alone it is unethical for the company, for knowingly putting your wife/husband with risks being put into the control arm to receive inferior treatment?
Do you think it is a right thing for the company to do to "temporarily" halt patient enrollment so it can wait to see if the unusual evening rate is indeed due to efficacy of DCVax-L before the temporary halt gets lifted for screening, or due to efficacy evidence, or something else ascertain?
What the company can say during this period of time! Can the company tell the general public the true reason for the halt (as stated above)? If the company did, would any patient in the trial have the right to know what kind of treatments they have had? If some patients find out they are initially in the control arm or still in the control arm, do they have the right to drop out the trial knowing they were or have been in the control arm (inferior arm) immediately so they can seek other trials or demand immediate access to DCVax-L?
Can you imagine what a mess that will entail? If the company did so, the trial will be severely compromised!
Said too much already, and I shall stop. Even with my big stake in the company, I still don't have enough time to participate in this message board. So my suspicion of those frequent posters, particularly those with no shares or claim to have a "core" shares.
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