$heff's $tation of $tocks & $olid DD

[gambler2075]

$SPHS DD Post #2

I was asked by a poster on stocktwits why I thought the FDA would possibly approve a drug that had a small STATISTICALLY significant effect, and how it could be possible for the FDA to accept a less than 2.0 IPSS point difference between PRX-302 and vehicle injection. He said that FDA needs all approved drug effects to be both CLINICALLY and STATISTICALLY significant.

Here is my reply:

You make a hugely important point... and I agree with you. All drugs need to have both CLINICALLY significant effects and STATISTICALLY significant ones as well. For example, if a drug were only to lower blood pressure by one point, from 121/80 to 120/80... who cares? Yet, you theoretically could make a trial of 10 million people and probably show a statistically significant drop from 121/80 to 120/80.

... and I get the FDA would not care at all.

So, I absolutely agree that PRX-302 would need to show both statistically significant, AND clinically significant results for the FDA to approve.

But here is the absolutely hugely important factor that the majority of retail is overlooking... and is key to understanding why I think the FDA will not absolutely require the 2.0 IPSS point difference over vehicle.

Take a look at slides 17 and 18 here (the Sophiris investor presentation on their website)

http://files.shareholder.com/downloads/AMDA-1OKDCO/510971677x0x832479/218964C6-1987-4BF0-8256-5B06F22A532D/Sophiris_Bio_Inc_June_2015.pdf

You can see Triumph curve on slide 17. You can see that PRX was about 3 points better than vehicle injection at 90 days, and maybe 2.8 points better at 12 days. However, look closely at the absolute IPSS values... at 12 months, PRX improved IPSS by 8 and vehicle ITSELF improved IPSS by about 5. However, the DIFFERENCE there was only 3 points (8-5).

Now look at this article looking at oral drug effectiveness for BPH (esp fig 3)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4162615/

Fig 3:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4162615/figure/pone-0107593-g003/

You can see that all of these oral drugs are only improving IPSS by ~2 points over PLACEBO, which improves IPSS by 0 as far as I understand (a placebo pill). HOWEVER, the huge reason why I think the FDA will not require a 2 point improvement over VEHICLE INJECTION is that, vehicle injection itself caused like a 5 point IPSS improvement over no treatment at all, no injection, or baseline IPSS score at 12 months. The thing retail is getting hung up on is the fact that vehicle injection ITSELF causes a huge IPSS improvement (5 points in TRIUMPH), so PRX is trying to improve on top of that.

But ask yourself, what really matters in the end? Is it improvement over VEHICLE? or improvement over no treatment at all? oral drugs on the one hand are only improving by 2 points over placebo, and IMO the FDA really cares about how the patients IPSS score would be if you injected PRX, rather than how much it improved over vehicle injection. So I think, given that PRX is showing a 8 point IPSS difference over 0 (although 3 pts over vehicle injection), the FDA cares more about that.

And that is why, IMO, the FDA will allow a <2 point IPSS improvement over vehicle (while still, in the case of triumph @ 12months, 8 points over no treatment). Also, consider the lack of PRX side effects... this is a huge improvement over oral drugs, which is, IMO why the FDA will see PRX very favorably.

All IMO. DYODD, GLTA.
-g