The Russian Ministry of Health are not going to approve a drug that hasn't been through the equivalent of a Phase III clinical trial. They don't like being used as a "testing ground" for American FDA efficacy data. They are not easy targets for untested drugs, and they don't like being used as guinea pigs.
With each day that passes, I get more nervous about Solagran's prospects with Bioeffective R. It will require a full Phase III trial, for which Solagran does not have the finances, or resources. That means partnering (at best), and further dilution in the share price.
This one is best watched from the sidelines.
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