This is a quote from the CEO after the 2012 completion of the Ph3 trial for treatment
Dr Jackie Fairley, Starpharma Chief Executive Officer said: “We are surprised and disappointed in not meeting the phase 3 FDA endpoint for the treatment indication in these trials, given the phase 2 trial results; however, we are also greatly encouraged by the statistically significant efficacy and excellent symptomatic relief shown for VivaGel® at the end of treatment (2-5 Days) in these studies and we do plan to fully explore the potential for regulatory filings based on these data. In addition we, and our expert clinical advisors, see the efficacy demonstrated with VivaGel®, the excellent safety profile and patient feedback as very positive for the prevention indication,”
Lets hope that the results were also logged for days 7-14 as per the new FDA requirements!
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