$1.25 - $1.45 after PR is too lowThe PIIb study design holds the potential to reveal a game changing treatment for BPH.
BPH affects about 70% of men older than 50, a North American patient population well over 50 million that grows by about one million annually...and that does not account for men over 50 elsewhere in the developed world.
Even with drug therapy, which helps considerably, prolonged BPH often leads to irreversible damage both to the bladder and structures related to it. The PI and PIIa studies revealed that PRX's treatment shrank the prostate by 25%, thereby relieving most of the dysfunction associated with BPH.
The duration of this effect seems to be at least one-year. It might be difficult to conduct follow-ups with patients who remain symptom free beyond one year. The PIIb design does not seem to have a scope beyond one-year, but because the treatment does not seem to have adverse side effects, the treatment could be administered again if and when BPH returns.
Needle biopsies on the prostates of treated subjects at one-year follow-up might provide enough information for FDA approval. If the IIb shows enough difference between the experimental and control arms, I think the FDA would be obliged to Fast Track the PIII or maybe even give provisional approval based on PIIb results.
PRX's CEO seems to have a sense of how to simplify and clarify; and if the PIIb findings are solid, and if the CEO uses that ability to present PIIb findings well, a share price of $1.45 would not last for more than a few minutes.
That's what I think.