Thanks Sheff. Right now I think the majority of retail is bearish, and have been so since Dec 2014. That was the time that Dan Ward went bearish as his bear thesis seems to be (and correct me if I am wrong, Dan... I would be shocked if you aren't following this board)... that since the interim analysis failed at 3 months, and the Triumph (phase 2) results had a smaller separation between the drug (PRX) and vehicle, at 12 months, as compared to the separation at 3 months, then that implies that the PLUS-1 (Phase 3 trial) results that are due in Q4 will also fail.
This is presuming that the final endpoint for the P3 is the same as it was for the interim analysis.
However, I do not believe that is true, after discussions with IR @ Sophiris. As I understand it, the primary endpoint is reaching statistical significance between PRX and vehicle, with respect to IPSS score at 12 months. For those of you that understand statistics, I think you will understand that it is far, far easier to reach statistical significance than it is to reach an arbitrary IPSS difference (of 2 points, like the interim analysis was). You could reach a stat-sig difference with even 1.5 or 1 IPSS point.
Furthermore, as per conversations with IR, the IPSS difference that the FDA would require for an injectable like PRX has not been decided. It could be less than 2 IPSS points. IR said that if (and this is a big "IF") the trial meets stat significance, then they would go to FDA and have discussions as to what the IPSS requirements need to be to meet the FDA standard. As of now, according to IR @ Sophiris, the FDA does not have a set requirement for injectable drugs for BPH as, as far as I know, there aren't any approved yet.
I think people are getting hung up by the statement in the Dec 2014 PR (where the interim didn't meet the 2.0 point difference), saying that the trial is 90% powered for a 2.5 point IPSS difference, given the SD of 8. Just because a trial is powered for that, doesn't mean that that is the requirement for the final endpoint. But I think people are assuming that since it didn't meet the 2.0 point admin interim endpoint, it won't meet a 2.5 point difference at 12 months. This may be true, but I believe that that is irrelevant, as (to my understanding), it is not the final endpoint.
Furthermore, the safety of PRX is quite good so far, as the drug is only activated in the prostate as that is where the PSA is (which activates the drug). This is a huge advantage IMO, compared to injection of ethanol or botox, which are active any where.
Anyway. These are all my reasons for being long. They are not to be considered investment advice. I am probably biased since I am a bull. I would appreciate if people would call IR @ Sophiris to confirm what I understand to be the final endpoint (a statistical significant difference between PRX and vehicle, rather than a 2.0 point cutoff that the interim used).
One last point... that is that if you look at the data from Triumph, the vehicle injection itself improved the IPSS score significantly (I think around 6 points?) whereas the PRX injection improved it to around 9 points. If you compare this to oral drugs on the market for BPH, I believe they improve the IPSS score by 2-3 points over baseline (no change). So I think this is an important distinction, as the PRX injection improves IPSS score (compared to doing nothing) by far, far more than oral drugs do. And in the end, I would assume the FDA would care more about how the patient did in the end.
Also, I think it is still kinda silly that the market cap of Sophiris is hovering around 15 million dollars. I think, for a company that has an impending (hopefully positive) Phase 3 trial coming in Q4, for a market as large as BPH is, is hard to believe.
Good luck to everyone in this tough bio market. Do your own diligence, trust nobody, and hopefully the truth will win out in the end.
g
disclosure: long SPHS
