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Message: A few thoughts on Soliris(Eculizumab) vs. RVX-208 for Compliment-related disease
excellent post Bear. It is my belief that RVX will seek to do any ODP under the auspices of the EMA. I think RVX has a good relationship with the EMA. I have also heard that it has good traction with Key Opinion Leaders in Europe. I think there are lots of issues at the FDA at the moment. Some of the stuff that is going on there with administrative delays and screw ups is very concerning. Lots of pharma companies have had problems with slow moving admin, delays and inter-departmental politics. It doesn't surprise me that there are currently two bi-partisan bills going through congress. Both GOP and Democrat constituents fed up. Can anyone give me a good explanation as to why doing a trial under the EMA, and not the FDA, is an issue? As far as I can see there are some very successful drug companies in Europe and there are surely blockbuster drugs in the US which went through trials under the EMA before seeking registration under the FDA? is this not a cost effective way for RVX to do its trial? If BOM successful under EMA them surely only a matter of time before it gets into US market, and will probably be sold to BP before that anyway. I think RVX is looking to develop other molecules anyway...
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