Like so many announcements from our company, everything is vague...

Like so many announcements from our company, everything is vague and surrounded by spin comments. The work of a very mediocre communications outfit in my view.

If they have been truthful, and I have no reason to suggest they have not, then these statements come from the FDA:

In their advice, the FDA acknowledged the demonstrated efficacy benefits of VivaGel^® BV although they have requested confirmatory data prior to approval.

So if you take this statement as a quote from the FDA, they acknowledge that Vivagel works based on the results of the two 600 person trials documented in the NDA! I suspect the statement which follows about "strong positive feedback from key opinion leaders, OBGYNs and patients in the US." is probably spin added by the communicator.

This is I think the most likely interpretation of anyone who reads this document carefully. If this is not what FDA wrote then SPL should find another communications outfit.

Elsewhere it is stated that FDA has no issues with safety, quality, or manufacture. So confirmatory data? Could it be that FDA are seeking data about Vivagel's usage in markets where it is already approved. Should we assume that they do not know there isn't any, yet. Because at the time the NDA was submitted it was expected that the product would have been launched in ANZ, by now.