The company indicated in the webcast that they did not identify any differences between responders and non-responders. They did notice that complete responders had a greater infiltration of the papilloma by the HPV6/11 T-cells.

There was however one substantial difference that they did not either realize or did not choose to talk about. The obvious difference is the number of surgeries in the prior year. Out of the 6 that had 7 or more surgeries in the prior year, 5 of 6 had a complete response. Out of those with 6 or fewer surgeries, only 1 of 6 had a complete response. Even the percentage reduction of surgeries in dose level one, correspond to the number of surgeries in the prior year. You can all look at it but this statistically significant.

The big question is why would more severe patients in terms of prior surgeries respond so dramatically better to the treatment. It must be that faster or less dense growth enabled greater infiltration of the papilloma. Maybe there is greater blood supply to these papilloma. This should be a point of hard investigation.

The implications are that while the data was impressive across the 12 patients, it is off the charts among those with a large number of prior surgeries. The FDA should immediately approve the vaccine for these very severe patients. They not only have very high annual medical costs but the vaccine is dramatically safer than surgeries. On the same front, the vaccine should be approved for those patients wanting to transition from Avastin which is costly and has lower efficacy and major side effects. Obviously the price to these patients could be much higher than currently contemplated.