There are multiple reasons a trial cannot be found to have an adequate and well controlled study.
The one I spoke about is manufacturing readiness -- or to be more precise, proving validation. 2.5 years ago, LP gave a speech on how difficult it is to move from phase II to phase III to demonstrate manufacturing validation. She stated it is even harder to go from Phase III to commercial launch when it comes to demonstrating validation.
A company needs to demonstrate validation before they can produce even one commercial batch.
I do not subscribe to any one theory regarding what is going on, because I am in the dark like everyone else.
However, there was quite a bit of silence between phase II and phase III. I suspect part of that was time needed to demonstrate validation.
Consequently, I would assume a longer period of silence might occur once more between Phase III and commercial production in order to prove validation.
If this were the issue, it's somewhat helpful to know LP thought they had a head start on this back in January of 2014.
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