Goodmorning, i have been following the RVX company for a few years and recently started following this interesting forum. Unfortunately, i have no pharma or scientific background :).

Could somebody with pharma and scientific background perhaps explain the typical timeline (or range) from potentially receiving Breakthrough Therapy Designation upto drug approval by FDA ? Its' not clear to me whether any additionally required trials have to be lengthy necessarily (or not) ? Is the fact that the good data presented by RVX are secondary endpoint data (CHF) or that they are prespecified subgroup data (Renal) an issue with regards to length of additional trials (or fact that sample size of these subgroups could perhaps be too small) ? An opinion based on past experience and specific data released yesterday by RVX would very much be appreciated.

Many thanks/regards,

DBS