HC approval shortcut?! Everyone on BB was upset at Endo's redirecting the trials for refractory use. I could understand why they do it besides the reason that this refractory use can fetch more price per dose. Graeme only stated this reason for the change to the shareholders.
But since the P3a and P2 data are obtained mostly from refractory patients, they probably figured it's better to do a trial that will add on top of successful data already to ensure there is no questionable surprises. Doing a trial of 1st line use may yield a result that shows Urocidin is effective but not as effective compared to BCG.
BCG is a live bacterial so it has two properties that is superior to Urocidin. 1. It can continue to multiply and thus increase the "dosage" autonomously after the injection and produce more antibodies, which I think is the agent that is initializing the immune-action destroying the cancer cells due to cross-antigenic action. 2. The live specimens also might have more veriety of antigen markers that can produce more different kinds of antibodies that can cross react with the cancer cells. In other words, more variety of "bullets".
This finding is still a possibility if/when we do our trial to use Urocidin as a 1st line drug. The only sure advantage we have with Urocidin is the safety factor and ease of use. If the trial shows that BCG is still more effective. Drs will have to convince the patients to use Urocidin first since it is simpler and safer to use. And go to BCG if it fails.
Under such reasoning, I am hoping BNC can also appeal HC for the approval for Urocidin without the comparative trial against BCG for their relative effectiveness. We might be able to appeal purely base on the safety factor which has been clearly demonstrated in all the previous trials.(Hopefully in the P3B also)
I hope this approach is acceptable to HC. It is unconventional, but quite logical. ( at least to me!!. )
JMHO. Sorry for the long post.