RE:Biofinderyou are absolutely right Dibah42.
but don't forget that primary and secondary endpoint were met at 100%. 100% is not commun for Drugs and really mean that Pg does what it is expected to do!
Plus FDA stopped trial after phase 2 since results on patients spoked for themself.
Anyway, in any cases, FDA inspection of LavaL plan ( that was already FDA approved) is scheduled for mid august so we can not expect an expedited approval this summer, but maybe in september?
The inspection is required since there was an upgrade related to the water system purification (or something like that). So not a big deal, it is an upgraded on the facility, not a whole new facility to be approved.