LTR, the entire approval process is insane, why shouldn't the regulators be more involved and if they see something positive at least issue an EUA permitting sales until either full approval is granted from a filing, or the EUA proves to be so effective no need can be found for further submission.
The regulators have no qualms about the years that are lost in the clinical trial and approval process, the whole thing should be seriously reduced.
Gary
Bullish