hi Chris, I don’t think the antibiotic dosing for the second phase III trial is the issue. This trial design was agreed with the FDA and supports the claim for the prevention of recurrent BV. E.g. the antibiotics treated the BV and vivagel prevented recurance in a population who suffered from rBV. Primary and secondary points all met. This supports the claim for prevention after treatment.
data from the first phase III trial was largely used (in my opinion) to support the BV treatment claim. This is the trial that initially missed the primary end points at TOC but was statistically signicant at EOT. SPL subsequently indicated that it had passed the primary end points at revised TOC, but I do not recall seeing detailed data on Testing of Cure for these revised / shortened time periods.
Hence, it appears that we can assume vivagel - prevents recurance of rBV after it has been treated with antiobiotics - treats bv up until end of treatment / whilst it is being applied - but that BV returns after around 3 weeks after treatment ceases (why we failed the first phase III primary end points).
My view is that we will work with the FDA to get approval of some sort with limited claims but that we will need more data for stronger claims around treatment. There are many products available now for eczema as an example that reduce the symptoms and prevent / delay recurance or provide temporary relief etc. I think we will see a similar outcome here.
The above is is all speculation just like Stockrocks assertion that we will definitely need another clinical trial.
Regardless, SPL needs to focus on preparing as best as possible for this FDA meeting and leveraging as much local FDA expertise they can. They need to launce in other regions ASAP and get more DEP programs into the clinic to stop the share price decline.
SPL Price at posting:
$1.00 Sentiment: Hold Disclosure: Held
