Welcome back AB, although I suspected you wouldn't be away too long.
it's very hard to speculate what the outcome will be at this point and we will be none the wiser until SPL meets with the FDA in 5-7 weeks time.
On one hand, i agree Tobes1234 that if it was a simple issue they would have already clarified this. Although there could be commercial reasons why they don't want to or perhaps the issue actually isn't that clear in the CRL and they need to qualify exactly what is needed. SPL have also stated they anticipate being able to "address the issue... through clinical efficacy data.."
The issue is not with safety, manufacturing or labeling based on the announcements, it's with efficacy and they need more data to satisfy the FDA. But more efficacy data for which part of the NDA and what vivagel claim, prevention of rBV treatement for BV etc.? Can we launch with modified claims regarding treatment or prevention? And exactly what will SPL need to do to provide the efficacy data, that's the big question.
The fact we had an SPA in place for a successful trial gave me too much confidence that the FDA would approve vivagel. It seems our recently appointed italian partners also believe we would get approval. However, & perhaps naively so, the SPA gives me hope that we will not require another full trial to launch. We had a successful trial in line with the SPA. Hence, my guess is that we can launch in the US with some restrictions and hopefully we can in parallel collect further efficacy data over time to improve / strengthen vivagel claims around treatment for BV. The fact SPL has engaged some senior experts in dealing with the FDA at this point is also a positive, although I note many wondered why not earlier.
DEP is the game changer and vivagel is supposed to be the revenue stream to fund DEP. We still have the rest of the world with mundipharma which somewhat offsets the US issue but for sure the US deal is critical.
