Good post Stock!
I have an analogy of this post for those that can't understand it: When one takes a polygraph test (helps employers to know who may be honest, or not), the one giving the test "moderator" will ask several known questions, such as where you reside or your wife's name is... These questions help the moderator to establish a "norm" which in our biopharma's case would be the phase on safety study on healthy people.
The moderator then shifts questions to topics that may upset the "norm" previously established to see if one is telling the truth or not. Our biopharma secondary phase now introduces people with known psoriasis conditions/diagnosis but unknown responses to our product(i.e. will the response generate a positive "truthful" response or a negative "lie or potential to lie" response. This is the phase we're in now - to see how people with the psoriasis condition respond to (or don't respond to): a) the cream, b) the formulation, c) various dosage levels of the formulation, d) response time, e) possible side effects, f) comparisons of current approved formulations vs our formulation, and any other things the study is attempting to prove.
The moderator then makes an assessment on whether the person tested can be trusted, or not. In our case, how well the cream does on people with psoriasis (various stages of developement or condition) or not. Polygraph tests are one person at a time, our tests are 25 to 50 people with tabulated and averaged results. The later clinicals will involve even more people with other similar symptoms and closer monitoring/fine tuning of dosage, or formulation concentration amounts. Who knows, maybe the color of the cream is a topic...
Hope this is understandable!
