How many times have you observed someone disclose a PIP with the intent to use the same SAP filed for a separate trial (e.g. the DCVax-L P3 trial: and late, but while still blinded), and subsequently indicate the use of External Control Arms (ECAs) that were matched in the same manner that the same separate trial used?
Oh wait, lemme answer that as you likely won't, probably never.
Which are the reasons why the company would have considered announcing the acceptance of the PIP trial to be a "material event" ... at least to our shareholders; despite the fact that you'll find no SEC rules which indicate the approval of a PIP trial is a material event. My point being that the company considered the approval of their PIP to be a material event, and so they PR'd it.