Ann: US FDA requests further data for VivaGel BV approval, page-8

It seems that in some cases they allow confirmatory trials after approval.
https://watermark.silverchair.com/d...si0eTQkjGjcHltiJPEKdiT_yiINChIhNrsYQSM2vESfkQ

JF said that I think it was 1200 women have used vivagel. What would a confirmatory trial involve? Getting another few hundred women to apply the gel and wait a week to see if it clears up the condition, or would it be about the recurrence? I’m not sure what spl management propose to say that hasn’t been said in their 100,000 page submission.

Suddenly Australia is a mention-worthy market again after being loftily dismissed by JF at the agm as being small and unimportant.

To me this latest fck up is a litmus test of JF’s credibility.  If this isn’t quickly fixed I’d rather see her replaced by someone who can execute and communicate better.