Just re-reading the transcript from the Life Sciences interview of Aug 26. One statement I'm puzzling over is in response to the question "What is your next milestone?"

Don replied "... an estimated 3,000 patient Phase 3 trial of RVX-208 this fall, which we'll run in Europe ... 250 of which will be based in China."

I wonder if he actually is hinting that they will not be seeking FDA approval for this particular trial, i.e. there will be no US participation in BETonMACE. Maybe the thinking is that if it's successful in Europe/China, then the FDA will approve it as well. I can't remember who alluded to the premise that FDA works in co-operation with other regulatory bodies and they have agreements in place to accept findings without having to conduct trials on US soil.

Seems to make sense, since ASSURE was run in multiple countries outside of the US.

Maybe it allows them to pursue other studies for orphan indications in the meantime with the FDA. Maybe the shelf prospectus that they filed will be to help fund those studies instead.

Hmm ... just random musings. Could be completely off base with these ideas.

I'm sure all will become clear at the AGM at the end of the month (just as in previous years ... right?)

masila