We know that RVX will be applying for Breakthrough Therapy designation. RVX mentions 90 to 120 days. What is not clear to me is what those 90 to 120 days mean.
Is that when RVX will file for Breakthrough Therapy designation, i.e. RVX will send in their application sometime in mid February to mid March? If so, when is the FDA expected to decide on their application?
If RVX has already filed for BT designation, should RVX not have press released that event? And if RVX has already filed for BT, does that really mean the FDA has only 90 to 120 days to decide? Sounds too little time, given the amount of analysis I assume the FDA does about these issues.
Thanks
Iconoclast