Actinium Pharmaceuticals Inc (ATNM)

[Fosco1]

Control arm being futile is not necesarily the worse thing that can happen, given the fact that the difference between Iomab-B treatment and control is already very clear, because the patients can switch arms and the treatment works successfully for almost all patients who have switched. Continuing the comparison with an untreated control group is therefore relatively useless..
However what is happening, in my view, is not in the initial SAP that would have allowed an early termination for showing benefit. So here are the alternative of the trial :

1) continue the trial till completion as they believe the control arm will finally show enough patients to compare with (mid 2021)

2) continuing the comparison with an untreated control group is relatively useless.. : therefeore there will be discussion with the FDA, as everything that is not is the initial SAP needs discussion and this shall "take time". Discussion meaning ask for early termination as TEST is behaving very well, compared with.... litterature

Interesting to know what IR would say regarding this scenario, for what I have seen of changing a control to historical data this can take many months... but for sure what has been removed for the 10Q that was in the original PR is that the study stop for early benefit during this interim.