House...in some ways We were inept...(Don't expect...what you don't inspect)...leaving your future in the hands of anyone...without oversight... is a sure fire way of getting Fu(ked...and not having the proper people in place to insure against that possibility..shows both a lack of accountability and very poor management.
Given that the FDA knows we got hosed...works in our favor...the fact that they issued regulatory action is indicative of how deep the damage...Our molecule is the only redemptiive article from our history...and from us being altogether scuttled.