Public Heel - that was my take as well ... the "bolt-on" is almost a given as a back up plan. While proceeding to NDA directly from BoM is a "long shot" they are not giving up that fight very easliy, and seem to be working to position their case based on 1) data data data, 2) unmet need, 3) safety profile, and 4) a "marginal" miss on primary endpoint due possibly to statistical powering.

I think the case gets even stronger "if" the Crestor combo was impressive in that sub-study, along with the secondary endpoints suceeding in an impressive way ... and thereby showing superiority over EVERYTHING from the currently "best available" options to these VERY VERY sick patients right now (since the best available = placebo).

It was QUITE OBVIOUS to me ... that Don believes they can make a strong NDA case now, by the way he was "pre-gaming" with the forest chart, the slide with other "failed' primary endpoints that made it to approval. You could tell this by the type of information being delivered, and by the tone. The argument may not be successful, and it is the appropriate way to curry favor with the FDA by calling it a long shot (respectfully), while also busiding the case and building groundswell support, and also walking in lockstep with academia to gain EVERY strategic and tactical advantage available.

He respectfully called it a long shot, I think it is maybe less than 50-50 but not a severe long shot ... the case simply needs to be made.

... "shoot for the moon, if you miss you are still among the stars" ...

There is little question in my mind that Don thinks there is a real shot at this based on data and what they know now, and if not, then getting the best terms possible from a sympathetic (if not "pressured") FDA would be the fall back.

... all JMHO though