Nice ... by mid-March? ... assuming filing occured by mid-Nov? No idea what goes into that type of application, pulling it together, with precise goals, planning, data, etc.

With BoM data readily available, and a team of scientists and business people, and guidance from regulatory inside/outside of RVX, I would imagine they could pull that application(s) together within a few weeks?  

Likelihood of break-through filing success? ... probably dependent on applying for the right things, impressive data from the strongest sub-studies with the better "p" values, and the largest and most morbid unmet needs? ... ESPECIALLY in areas of strongest unmet needs? ... safety profile

... just gotta get that door cracked open for legitimacy and momentum, I would go as small and narrow as I had to in order to get agreement from regulatory too move forward, to get this off the white board and into the hands of sick patients where most needed, while doing further studies.