So it was pointed out to me that the placebo pills in the oral drug trials all pretty much have a placebo effect... so it is a mistake to assume that the oral drugs only affect the IPSS by 2-3 points over 0.
In retrospect, I think that is correct. In the oral drug trials for BPH, the placebo pills did have an effect, and the oral drugs improved over that effect by a few points, to my understanding. Still, that placebo effect was not zero.
I don't know the average amount a placebo PILL would help the IPSS score, but I guess you could get a sense here from this figure. In it, looking at 24 weeks (mind you, this is 24 weeks, and not 52 week data like PLUS-1 will have), the IPSS improvement of placebo is 3.8 points, whereas terazosin improved it by 5.3
So terazosin improved over placebo by about 2.5 points.
Still, I will point out that this is not as good as PRX at 12 months in the triumph trial improving IPSS by about 8 points, and vehicle injection improving it by about 5 points.
It is just that the vehicle injection ITSELF improves IPSS so much that PRX has to improve on top of that, and a 3 point improvement (as seen at 12 months in the Triumph (P2) trial) does not seem as impressive.
I would argue that the FDA would take this into consideration, because, after all, what is important IMO is what the patient feels using the drug, and it isn't really so important how much the improvement is over placebo since injectable placebos (vehicle injection) themselves are causing an improvement in IPSS symptoms much more than oral drug placebos.
GLTA. Do your own DD... Also remember that this stock is incredibly thinly traded with such a tiny market cap and it may be a bad idea to chase if it runs up significantly.
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