$SPHS: IMO it all comes down to if you believe the 2.0 pt IPSS difference which FDA says is generally the requirement for oral BPH drugs, applies to SPHS or not, for their injectables.
I believe FDA does not require a 2 point IPSS difference over vehicle for PRX-302, due to the fact that vehicle injection causes such an improvement in IPSS above and beyond placebo.
The AF bash article quoted that Dr. Davies who was ridiculously bearish and IMO many retail investors do not understand the drug.
I believe FDA will look at the data and the fact that the drug is not activated without PSA (only in the prostate) and consider it superior to NYMX's drug.
Plus, I think ppl think that NYMX and it's positive long-term extension trial make it possible for NYMX to apply for BLA in the US. IMO, 1 positive LT extension trial does not convert 2 failed P3's into 2 positive P3's, so IMO, in the eyes of FDA, NYMX has 0 positive P3's.
But right now people are thinking NYMX is about to get FDA approval, and NYMX is way better at PR'ing their "results".
My prediction is that big pharma will partner with SPHS and the PPS will gap up to 4-5$ at that point. The market cap IMO is crazy low at this point, insultingly low, IMO. But time will tell.
g
