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

[gambler2075]

$SPHS: Keep in mind that I am possibly biased as I am long $SPHS.

I would remind everyone that they need to do their DD and make decisions for themselves. I can only write my thoughts, which is not trading advice, and, it is important to note, is coming from the perspective of buying in the 55-60c average range (lowered cost basis from 0.70's due to trading around).

So... on to my personal take on the situation:

Right now, we have statistically significant phase 3 results, which are still (IMO) being misinterpreted by the retail masses, mostly because they are looking at the 1.0 point IPSS difference over vehicle, which was much less than the 2.0 point IPSS difference that the interim analysis was targeting.

I will say that it is well known that oral BPH drugs have had to show a 2.0 point IPSS improvement over placebo in order to be approved. It was generally accepted that 2.0 IPSS points over placebo is what the FDA wants.

Since SPHS targeted it's interim analysis at 2.0 IPSS points over vehicle in the Dec 2014 interim, I understand why a cursory look will say that "yeah, the primary endpoint was only 1.0 IPSS points over vehicle, so the FDA will never approve it"

This is the big factor however. If you read through the literature on PRX and injectables, I personally believe there is a significant effect of vehicle (injecting saline placebo into the prostate) causing a significant improvement in IPSS symptoms. Looking at the raw numbers, you can see that IPSS was improved by 6.58 IPSS points (after 12 months) in the Phase 3 trial. This was 6.58 points BY THE VEHICLE (PLACEBO) injection.

Now lets compare this to oral drugs approved for BPH. After Cialis was approved for ED, it was later approved for BPH. Take a look at some of the IPSS improvements across all the studies:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4054509/

If you look at those IPSS improvements for Cialis, you can see those improvements of perhaps (to take an example) 5-6 points for Cialis, ~3 points for placebo:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4054509/figure/fig2-1756287214531639/

Take a look at some of those numbers from the paper. We are dealing with improvements of approximately 3 points for oral placebo drug for BPH, and about 5-6 points for Cialis for BPH.

Now look at this publication:

http://www.oregon.gov/oha/pharmacy/therapeutics/docs/ps-2010-03-bph.pdf

They compared 2 drugs used for BPH, Uroxatral and Flomax. Note that the IPSS differences they found were approximately 6.5 points for Uroxatral and Flomax and -4.6 points for placebo. And this was at 12 weeks.

Now, look back at the Sophiris PR, and realize that that 1.0 point difference (7.6 vs 6.58) is misleading because the PLACEBO (vehicle injection of saline) ITSELF, improved IPSS by 6.58 points. And this was at 1 year. If you compare the data at 18 weeks for PRX-302, you get an IPSS difference of 8.31 vs 6.89:

http://investor.sophiris.com/releasedetail.cfm?ReleaseID=941842

"The maximal effect of 8.31 points improvement in IPSS vs vehicle 6.89 points (p = 0.012) was achieved at Week 18"

So as you can see, PRX-302 is improving BPH symptoms much more, as compared to baseline, than oral drugs. And it also has (IMO) a better side-effect profile.

Now you can see that the majority of people don't understand the true benefit that PRX-302 is having, because it is being disguised by the effect of placebo (saline injection). Why is Saline injection causing such a benefit on BPH (more than even oral drugs!)? Because as some of the papers have alluded to, the injection of saline may act to blow up prostate cells, and thereby improve BPH symptoms.

Ok. So now we go to our competitors. Good 'ol NYMX. I feel that NYMX has managed to convince everyone that they are right on the brink of applying for a BLA, with their LT extension data, despite the fact that they have 2 failed P3's this past year. It is my opinion that the FDA is never going to accept their data for approval, because, according to the SEC filings from Sophiris, the FDA generally requires 2 positive, adequate phase 3 results for approval.

http://s10.postimg.org/plzyddqjt/SPHS_2_phase_3.jpg

NYMX, IMO, is trying to convince people that their LT extension trial has miraculously made their 2 failed prior P3's into 2 successful P3's. But I don't believe the FDA will see it that way.

IMO, Nymox has managed to convince everyone that they are filing for a BLA based on their BPH data, but they will not specify, or confirm that they are filing in the US, it is "wherever possible"

http://www.nymox.com/resources/content/d244.pdf

"The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories. "

IMO, people are thinking that $SPHS is way behind in the race for BPH injectables, and that is IMO keeping the stock under pressure.

Now, let's address the AF/Dr. Davies bash. Here is the link to may analysis:

http://s8.postimg.org/h69u721et/Dr_Davies.jpg

I don't see how he could say this doesn't work when it has a better IPSS improvement than currently approved oral drugs (7-8 point improvement vs ~5 for oral BPH drugs, over baseline).

So I think right now, weak hands, those that haven't done DD, those that were holding from 80c, are getting shaken out of the stock, and IMO big pharma knows that this stock is worth far more than 35M$ mcap. We have a drug with a positive P3 in a market like BPH... that is IMO worth FAR more than 35M$. Furthermore, this stock was 2.80$ BEFORE the failed interim, and it should be far higher (7$ right now IMO) with a positive P3 result.

So, what is next? Well, I think that the prostate cancer proof of concept trial in Feb-Mar 2016 is another huge catalyst... Basically I think it is going to be very likely to succeed... they are basically finding these low-intermediate prostate ca lesions, locating them by MRI or Ultrasound, injected them with something that destroys prostate tissue and anything with PSA in it (prostate cancer lesions are swimming in PSA), and then 6 months later checking to see if they were destroyed. IMO it will be shocking if they were not destroyed.

Compare that to the BPH trial. In that trial, they basically had to hope that the PRX injection, which was injected in various places, destroyed enough prostate tissue so that the mass pushing on the urethra was decreased, allowing easier urination. In this case, they are just injecting into lesions and seeing if those lesions are destroyed. No guarantee of success, but IMO far more likely to succeed. Also it's a phase 2 trial, which IMO are easier to succeed than phase 3 trials.

So, that is why I like the stock. I think this is worth 7-10$ within 3-6 months, and I plan to hold the vast majority of my shares for that.

That being said, people need to do their OWN research, and come to their own conclusions. This is not trading advice, and I could sell my shares at any time. Good luck.

gambly1 (on stocktwits)