"dumbest action anyone would take"??? No, the "dumbest" action anyone could take is posting that it "would be a HUGE mistake to reveal a possible weakness."
Revealing a "possible weakness" would NOT be a "huge mistake." If anything, it would justify suspending enrollment and show that they are trying to address the issue, an action that might actually inspire some investor confidence. Moreover, they wouldn't have to SPECIFY what they modified OR how they modified it.
HOWEVER, they did NOT indicate that they modified ANYTHING. Indeed, they EMPHASIZED that the deaths were NOT device related and therefore IMPLIED that there was NO NEED for any modification of the protocol. And THAT makes SENSE!
But what did SSH turn around and do? They THEN announce that they filed a supplement to the IDE with the FDA. That IMPLIES that they were seeking to change the protocol since NO filing was necessary if the protocol was to remain unchanged.
NOW investors have to wonder WHY SSH filed the supplement IF the deaths weren't device related. ANY attempt at changing the protocol looks SUSPICIOUS, but after FOUR deaths, even MORE SO!
And THAT was my original point! WHY did SSH file the supplement IF the deaths were indeed NOT device related? They NEED to clarify that for investors. Like I said, I think they did it just to have a future excuse for slow enrollment.