More clarifications are needed that will hopefully be sorted out in the coming weeks:

1) Does the approval by "a European Regulatory Authority" actually mean approval for all of Europe? How many European Regulatory Authorities are there? Do they mean European Medicines Agency or is this particular "European Regulatory Authority" simply a subset of Europe and possibly a postive sign that things with the EMA are going well. Perhaps we are reading too much into this news release. It is rather vague and may just be a teaser to keep us happy. While it is encouraging, its ambiguity leads me to believe that complete Europe/EMA endorsement is still pending. They "met with various European regulatory bodies" and are still awaiting the approval of "additional regulatory bodies." Are these additional bodies other European approvals, or are the other bodies related to the US and Asian sites? Speaking for both myself and others on this board, I don't think we know for sure how to interpret this press release. Nonetheless, it is a positive statement.

2) What ramifications are there if BETonMACE fails to get FDA approval for Phase III? If the trial is run as a Phase III in Europe/Asia but did not get FDA approval and no US sites are included, can BETonMACE be used to file for drug approval in the future in the US? What about Canada? Or would another US/North American Phase III trial, in addition to Asia/Europe BETonMACE, be needed to seek US/FDA approval? Is it possible for it to be considered Phase II in US but Phase III in Europe/Asia? That seems kind of silly, but I really have no idea.

I really think an RVX blog would be in order to clarify these topics.

Best,

BDAZ