DEP always first, page-20

Chrisnj, yes this was the claim by SPL (apparently based on FDA alignment) but this was before they received the CRL. I assume it will still be their end goal and will be how they launch in other regions.

But the situation is different now for the US, hence I am speculating about possible scenarios based on the two phase III trial designs and their results.

It has long been known that that the second phase III used antibiotics and then vivagel. The antibiotics treated the BV to set a baseline of BV free participants and vivagel was subsequently applied, which to my simple mind indicates prevention of recurrence & not treatment. the trial met all primary & secondary end points for prevention of recurrence. This is still a huge win as prevention is a huge market.

The first phase III trial demonstrated statistical treatment at EOT but not at TOC, so did not meet the primary end points (at the time). Subsequently the FDA revised the time frame for TOC and apparently this meant vivagel demonstrated treatment for the revised TOC. So this was re-interpreted as a successful phase III for treatment. But it is not clear to me what data was available to satisfy the revised TOC achievements for the first phase III and did the FDA share this view based on the trial design? e.g. did we have enough data at the revised TOC? maybe someone can find that?

The NDA submission was based on both trial results for treatment and prevention. Looks to me like both trials strongly support an argument for prevention when vivagel is applied (meeting secondary EOT targets in the first phase III and the primary end points in the second phase III) but maybe the FDA wants more information on the treatment claim, either by reviewing the existing data, reviewing data after a market release or with further trials. Remember the FDA have no concerns on safety or manufacturing based on SPLs announcements.

I state again, the above is speculation and I'm open to others shooting holes in my thoughts or providing opposing views. but I feel we have a strong chance for some level of approval with restricted claims and that we will be able to launch in some capacity in the US whilst we get more evidence, if SPL also agrees to this as it may diminish their pricing power. The rest of the world can proceed with their launches ASAP.