Dash. we are referring to the Open Label compassionate use trial correct ?...where they all got RLF-100. If so I think the term "placebo effect "is misleading . I think its more Investigator Bias. They gave RLF-100 to 23? and 21 got better ( from memory ) So this was better than what historically they have seen in such patients ...Therefore ...it must be because of RLF-100. We gave them the drug ...they got better ...must be because of the drug. Well how do we know this particular set of patients would not have got better on current SOC anyway.
The only way to do that is run a blinded trial ...SOC plus placebo vs SOC plus RLF-100 ...remove risk of Investigator bias . Investigator does not know who got the saline solution and who got RLF-100