Bear, thanks as always for your well articulated thoughts.

My belief re off-label ... once RVX-208 is actually sitting in FDA approved "safe and effective" status with well documented safety plus efficacy, clinicians have the "cover" to write for other indications, probably starting with those that have the highest clinical risks and have not responded to other therapies, assuming RVX-208 has data suggesting benefits for those types of patients. It is a nothing to lose scenario for very sick non-responding patients, and risk "cover" for the clinician. And if not approved from BoM (highly unlikely) then those additional indications could get prioritized andfast-tracked, but guessing there would still be P3 studies done to get official indications, while off-label use grows potentially.

Could be "technically" wrong about ANY of that above, but from from 30 years of practical experience observing other drugs & devices, and off-label utilization I think it could/should/would "roll like that or similar ...... RVX and its agents would be STRICTLY VERBOTEN from promoting off-label use though, of course. But, the clinicians would figure their way toward preserving quality of life, and saving lives, with a promising option with a strong safety profile, if necessary.

Insurance companies would also figure out that it is much better for them to pay for 208, rather than an extended period (or lifetime) of ridiculously expensive palliative care and therapy.

JMHO