North, I don't know about the V Cream. I am not sure if you already saw this but I have attached info related to the Libigel trial from the AHJ article.
Efficacy was part of this trial. So they have data to support an NDA. Simes told me they were not collecting Efficacy data - no doubt bound by the non-disclosure agreement, which was probably not in place when the article was written.
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