To be more general than you may wish....
Statistical expressions within a group size in a P2
with primary endpoint of safety NEED verification of
Efficacy are indeed suspect.
It is unknown because of methodology what
(DZP, A 2-73, A+, etc) affected second derivative
manipulation of testing results. The standard precaution
within the scientific community, let alone an imprecise
assessment of the "stage" of the disease, mandates a longer
and broader evaluation.
I will be comfortable saying Hampel's measured enthusiasm
is a model for interpreting the research in A 2-73 to date.