has changed, no more trial conducted, so fundamentally, somebody thinks there is very little chance of approval, otherwise this should have been approved earlier. So I do not think it is worth a big gamble.
I do not believe that there is little chance, Ency has done a double blind trial with a PAH drug already in the market, and came out ahead on safety, same or a little better at efficacy. I always go with fundamental.
Anyway, FDA is odd, but DNDN is different, AIPC patients have no effective medical treatment, and provenge is absolutely safe, nothing alien is introduced in the drug.
I do not believe that there is little chance, Ency has done a double blind trial with a PAH drug already in the market, and came out ahead on safety, same or a little better at efficacy. I always go with fundamental.
Anyway, FDA is odd, but DNDN is different, AIPC patients have no effective medical treatment, and provenge is absolutely safe, nothing alien is introduced in the drug.