A recent history of VivaGel BV trial results and failures, and how they may influence the ongoing 5 year FDA appeal process.
2012 results
SPL7013-015 VivaGel Phase 3 trial (treatment)
247 participants at 18 USA sites
Primary Endpoint not met.
SPL7013-016 VivaGel Phase 3 trial (treatment)
249 participants at 11 USA and 9 Europe sites
Primary Endpoint not met.
2013 results
SPL7013-014 VivaGel Phase 2 trial (prevention)
205 participants at 10 USA sites
Using key criteria, according to Starpharma, the difference between 1% VivaGel and placebo groups was close to significantly significant.
When using a combination of criteria, according to Starpharma, the difference between 1% VivaGel and placebo was not statistically significant.
2017 results
The following trials formed the basis of FDA submission, and subsequent rejection and ongoing appeal)
SPL7013-017 VivaGel Phase 3 trial (prevention)
585 participants at 66 sites in US, Canada, Mexico and Puerto Rico
Regarding primary endpoint, the difference between VivaGel and placebo was statistically significant.
SPL7013-018 VivaGel Phase 3 trial (prevention)
636 participants at 46 sites in UK, Bulgaria, Romania, Ukraine, Hungary, Czech Republic, US and Thailand.
Initial primary endpoint results between VivaGel and placebo were statistically significant.
However due to anomalies noticed, an investigation was conducted prior to data unblinding. After an additional analysis was conducted excluding a number of sites in countries such as Ukraine and Romania, the difference was reported as not statistically significant.
I’m only speculating, but it may be that because both of these two trials (US and Europe) were designed specifically for, and run concurrently, to support a FDA submission for the US market, the FDA may have rejected the NDA on the basis that both trials were technically not successful in meeting primary endpoints (even though the US trial passed with flying colours)
One can argue until the cows come home if this is reasonable or not, or if skullduggery is involved. There may also be other issues with the data or submission that we as lowly shareholders will never find out about.
I still refuse to believe that the FDA did not recently give Starpharma a FDA response/decision date or timeframe regarding the latest formal appeal. If they received such advice, it should have been communicated to shareholders.
P.S. The information contained in this lengthy post was collated with best endeavours and intent, so apologies if there’s any errors. Pretty sure there’s none.
Sarge
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