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GBSN: Huge bounce off the lows... I ended up selling my last 100k shares at 0.252... made 127K$ off the whole trade.
$SPHS/$GBSN: IMO prostate cancer data is coming for $SPHS in Feb 2016 (at least that's what clinicaltrials.gov has listed)... I'm holding a moderate sized position into that.
$GBSN may continue the bounce here... I did sell the majority of my 1M share position at 0.29 ish for +127K$, but holding a small 100K position from 0.237ish... looking forward to the runup into/gap up into (IMO) likely FDA approval...
http://www.bilderload.com/daten/gbsn8HW4A.jpg
g
Exactly. The point is that if you could suddenly gain possession of 40M shares at 0.20, you would want to hold them until you could sell them at a much, much higher price. There is no reason to flood the market with them and crush the price further, once you own them, IMO.
Since 510K approval is around the corner, IMO, the price will probably be run up to ~1$ so those shares can be sold for a massive profit.
All IMO.
GLTA, DYODD.
g
OK, I gotta speak up here, but your comment is just ridiculous, and makes me think that you just blindly follow Sheff... buying when he buys, selling when he sells... without really doing DD yourself and understanding what it is you are buying or the reasons behind it.
It is obvious that Sheff does a ton of work researching companies... and IMO, the toughest part of bio investing is to FIND the companies that are undervalued in the first place. At that point, it is relatively easy to do the DD and see if you like to buy, sell or hold.
By your complaining that you cannot copy Sheff exactly it makes me think that you are just blinding pushing buy and sell buttons as soon as possible after he does, which... is kind of sad, IMO.
Here is the most relevant quote from Livermore, IMO:
http://www.asxmarketwatch.com/2011/12/the-top-30-quotes-from-jesse-livermore-on-trading-and-investing/
Jesse Livermore Quote 7:
“The average man doesn’t wish to be told that it is a bull or a bear market. What he desires is to be told specifically which particular stock to buy or sell. He wants to get something for nothing. He does not wish to work. He doesn’t even wish to have to think.”
*******************************************************************
My recommendation is that people start trying to LEARN to fish, rather than just trying to hang onto Sheff's coattails and hope he hands out free fish and gives them to you.
Good luck.
g
$SPHS: Prostate cancer data coming (interim) early 2016... I'd say within a month or so. IMO the co partners for BPH, I'd say PPS jumps to 4-5$ on that, and I think it happens in the next 2 months, max.
Added 134K shares yesterday at 1.53... I'm probably going to stop adding, don't want to hold more thant 400K shares through that data...
g
$SPHS: IMO it all comes down to if you believe the 2.0 pt IPSS difference which FDA says is generally the requirement for oral BPH drugs, applies to SPHS or not, for their injectables.
I believe FDA does not require a 2 point IPSS difference over vehicle for PRX-302, due to the fact that vehicle injection causes such an improvement in IPSS above and beyond placebo.
The AF bash article quoted that Dr. Davies who was ridiculously bearish and IMO many retail investors do not understand the drug.
I believe FDA will look at the data and the fact that the drug is not activated without PSA (only in the prostate) and consider it superior to NYMX's drug.
Plus, I think ppl think that NYMX and it's positive long-term extension trial make it possible for NYMX to apply for BLA in the US. IMO, 1 positive LT extension trial does not convert 2 failed P3's into 2 positive P3's, so IMO, in the eyes of FDA, NYMX has 0 positive P3's.
But right now people are thinking NYMX is about to get FDA approval, and NYMX is way better at PR'ing their "results".
My prediction is that big pharma will partner with SPHS and the PPS will gap up to 4-5$ at that point. The market cap IMO is crazy low at this point, insultingly low, IMO. But time will tell.
g
IMO, $SPHS partners with big pharma in the next 3 months. I also think the stock is insultingly cheap for the data it has, but we shall see.
Discl: partial long
TTNP: Nice video segment on CBS (Philly) in mid Dec:
http://philadelphia.cbslocal.com/2015/12/17/fda-closer-to-decision-on-approving-implant-treatment-for-drug-addiction/
discl: partial long
g
Nice video segment from CBS/Philly affiliate in Dec... imagine if this was on the CBS evening news, hahaha....
http://philadelphia.cbslocal.com/2015/12/17/fda-closer-to-decision-on-approving-implant-treatment-for-drug-addiction/
discl: long partial TTNP position.
TTNP: Agree, IMO high likelihood of approval this time... nothing is guaranteed but... last time they cited 3 reasons why they issued a CRL... TTNP did another trial and got a positive P3, and limited the target population to the <= 8mg Buprenorphine target...
http://www.titanpharm.com/press/2013/13-04-30-Titan-CRL.htm
https://braeburnpharmaceuticals.com/braeburn-pharmaceuticals-reports-positive-results-from-phase-3-study-of-probuphine-for-opioid-addiction/
g
Discl: partial long
Coulda/woulda/shoulda gone short XBI at 70 then...
Possible $THLD bounce happening now (Jan effect bouncer?). Co guided for year end cash (end of 2015) of 40-45M$, which is about 59c per share.
According to yahoo, it is listed at 79c/share.
Merck (EMD Serono) is probably going to make a decision on evofosfamide in NSCLC. IMO, it is already written off by the public... if Merck continues with it, then that is huge for THLD.
GLTA.
Discl: Long THLD
Big $THLD bounce off the lows... maybe a Jan effect bouncer? hope so! (discl: long THLD)
Very important article on Dr. Pazdur... I remember dreading hearing him speak at adcoms over the years...
http://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html?_r=0
Very important article to read on Dr. Pazdur... I remember dreading hearing him open his mouth during adcoms over the past years when I was long...
http://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html?_r=0
-g
p.s. all the biopharma trading implications aside, I will say I am very sorry for his loss and urge all of you to spend more quality time with your loved ones, because you never know how much time everyone has. Including myself.
When is KBIO opening, and where? Still grey sheets? Are they still trying to appeal nasdaq delisting? Also what are people's guesses as to the open? I say 33 cents :D
Tax loss harvesting, More useful info:
http://fairmark.com/investment-taxation/capital-gain/stocks-and-other-securities/last-day-sell/
Meh. TBH I am kinda annoyed it is running up as I wanted to add another 200-300K more shares but oh well... maybe I will have a chance later.
I will make a bold prediction... I still do think that $SPHS partners for their BPH drug by mid 2016, and trades above 5$ by that point. For that reason, I still continue to hold 220K shares. I also think that part of the reason $SPHS can't get no respect (Rodney Dangerfield-style) is that people think $NYMX is in the lead for FDA approval, but IMO there is no way they are.
I also think that THLD hits 1$ within 3-5 months, but time will tell. Long $THLD (0.58 ave) and $SPHS.
Happy holidays, everyone.
g
Wow, $SPHS certainly didn't do what I was expecting after positive P3. Should have sold it all at above 3.80's... but didn't, of course. Sold the majority of it, realized profits of ~570,000$, still holding some though. Bought some THLD. IMO it's oversold here, but time will tell. Maybe it will end up being another 1 year hold.
g
KBIO longs utterly destroyed after arrest: http://www.bloomberg.com/features/2015-martin-shkreli-securities-fraud/
Wonder if they un-halt it today and where it opens... man what a black swan.
g
THLD: Long at 0.60
Exactly. IMO the microcap bios have done their thing for the past 5 years and now are toast. IMO today marks the top, or close to the top, of the bio market, with rotation out of these small cap bio names... need to focus on stocks that have very near-term catalysts or cash support.
g
Long partial at 5.90s
ZFGN is going to be fun tomorrow... I have no idea what the bottom is going to be, of course. Also, it just feels like this is going to be a buy around end of year for a bump into 2016... We will have tax-loss selling in late december and of course if the drug is linked to the death, its going to be another AFFY, but if not, it's going up big-time...
g
Sold ZFGN flat at 6.40 ish. I think they could get a full clinical hold in a couple of days.
Long ZFGN 6.30's
$CBAY I also like the fact that probably partnership for P3 is coming next year (at least that is their goal) and they don't feel deterred by the Lesinurad adcom:
http://seekingalpha.com/article/3681976-cymabay-therapeutics-cbay-ceo-hal-van-wart-on-q3-2015-results-earnings-call-transcript
Mara Goldstein - Cantor Fitzgerald
Hello, thanks very much for taking the question. I have two and the first is related to arhalofenate and I’m just curious more than anything around some of the takeaways from the Lesinurad FDA Adcom meeting and how that informs anything for potential partnership in terms of what partners may have had notions about before them and about basically not in the end of Phase 2 meeting. And then, I just wanted to ask on MBX-8025. On the secondary endpoint, I know you just said how that the additional five patients could be meaningful in terms of looking at the primary endpoint. And I’m curious as to how proportional effects might be on some of those secondary endpoints basically as it relates to positive indicators of cholesterol and if you might be able to comment on that?
Hal Van Wart - President & CEO
Sure. Well let me take the first question, first. We listened with great interest into the Lesinurad Arthritis Advisory Committee meeting that was held a week or two ago and we would of course prefer not to comment on Lesinurad itself but there were a tremendous number of things that were very important for us to hear and learn about.
First of all, we were very clear from the discussion at the committee that both the committee members as well as the FDA are looking for a safe effective urate drug to be used in combination with XL inhibitors. And it's also clear that both the committee and the FDA were looking for clinical benefits such as flare reduction, focus resolution in addition to improvement in the surrogate markers serum uric acid.
Now that made us all feel very good because this almost matches identically arhalofenate profile where we're able to get patients not only to the uric acid goal but do it in a way that reduces their flare way which is very clinically meaningful. And we do it so far with 1,100 patients of beta with no signal with regard to renal safety. So we came away feeling pretty good that we are synchronized with the medical community with regards to the unmet needs in gout and that arhalofenate truly has something to offer.
Now we think of course that will play through very well to the pharma companies that may have well listened into that presentation or can access the documents and confirm to themselves that the advisory committee probably would have liked arhalofenate.
$CBAY: I personally like the fact that it is trading well under cash, it has been beaten down due to postponing results from Q4 2015 to Q1 2016, due to increasing number of patients to 13 from 8, and the fact that the lesinurad adcom is in late dec (dec 29) and people think that lesinurad will be approved. I personally am not so sure, but the 10-4 positive adcom did make people think that IMO. Should be interesting going forward. DYODD!!!!
Discl: long partial $CBAY
g
CBAY: I do like the name here, bought a relatively small position for a hold, should be interesting. I think it's decently underpriced here but I could sell at any time.
g
Yeah, that AF bash article from Dr. Davies on Fri the 13th was total garbage, IMO. His claims of lack of efficacy were totally unfounded if you look at the fact that PRX injection is showing a higher efficacy (7.6 IPSS points at 12 months) than even approved oral drugs like flomax and uroxatral (around 6 IPSS point improvements).
It was just that the saline injection caused an improvement of IPSS of like 6.58 IPSS points, so the difference between PRX and saline was only 1 point. Still stat sig.
g
Bought back 60K $SPHS shares at 2.10, we are close to a bounce IMO.
$SPHS Thanks for the reply Sheff. Certainly was a high risk-high reward play, and it will be interesting to see how it plays out.
Thanks for all the great DD you do on your stocks, they definitely jump-start the DD process for me in doing my DD on a stock.
g
$SPHS Sheff, I note that you said that $SPHS at 0.75 was either "the greatest bargain in the biotech space now or one of the riskier plays into a catalyst"
IMO, you were definitely right about that... the stock was trading in the 40c range less than a year ago, and reached over 4.00$ premarket on the day of positive P3 results. Now it is trading in the low 2$ range.
I am curious, now that we have had positive P3 results, if you have a second, can you tell me what you think about $SPHS?
Thanks,
g
Posted up some deep (IMO) $SPHS DD here:
Have a good weekend.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118661180
g
$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)
SPHS: I still think this is undervalued for the longterm (3-5 months) as they have a positive P3 result and they are currently consolidating gains from the 80c level. I think we are almost done with the weak hands puking up their shares, but then again, I am averaged in at 55-60c so I obviously don't have as much to worry about as someone buying in at 3.50$, 2.50$, or 2.10$ here.
I think it is silly that after positive P3 results, we are trading LOWER than where we were before the interim in Dec 2014. So, I continue to hold. I also think it is silly that we are trading at like a 35M$ market cap with a positive P3 result in a huge market like BPH (multibillion$ per year). That being said, I think the stock is pressured by the Dr. Davies/AF bash, and we on the SPHS stocktwits board have reached out to IR (Mr. Peter Slover, CFO) and here was his reply:
http://charts.stocktwits.com/production/stream_45669059.png?1447945508
Anyway, I am done for the day after taking out 45K$ of todays profits (from my SRPT and CLDN trades) to pay estimated taxes (I wish all of my trading days were this good!)
http://s13.postimg.org/hdilfhvmv/11_20_et.jpg
I did buy back 65K shares of SPHS this morning at 2.10 and I plan to hold those for now.
GLTA and have a good weekend all. And this of course is not trading advice. As a reminder, I am averaged in at like 55c on SPHS. Way less risky for me. But I am still holding the vast majority of my shares.
g
Quick $CLDN flip at 1.28 ave from 1.18 (+8.8K$ on 80k shares)
http://postimg.org/image/j8llapiq3/
Thanks! Nice exit! I was worried about that 33$ which I was watching premarket and thought was stronger resistance. But watching that 32.5 it seemed like they kept on supporting that/accumulating at that point.
Oh well. On to the next one!
g
Sold 5.2K SRPT at 32.8, + 37K$
http://postimg.org/image/62ak343tj/