Oh so you admit there were european trials
No, there were ad hoc studies sanctioned by a German State (not the EMA - didn't exist then, or the FDA). Where the ad hoc studies run by Lohr, were arbitrarily called Phase 1, and Phase 2 by Lohr. Neither in structure, and results would they be accepted by the FDA today. Now I wonder why the FDA placed a hold on an IND for a Phase 2b. Dependent on ad hoc studies from 20 yrs ago?
Of course Crabtree (the great guy) pleads they don't know why a Hold was put on it. They should know with no excuses, no later than 02-Nov. What's the odds they will post the FDA letter giving the reasons in an 8K? For SHs to see? As opposed to some PR pump saying they are discussing it with the FDA? Tick tick tick. LOL
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