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Bad link sorry. disregard prior post.
$MSTX "Epic Considerations for the EPIC Clinical Trial" Possible topline EPIC ph 3 at this conf. on 4/11? https://www.eventbrite.com/e/click-here-9th-annual-sickle-cell-disease-research-and-educational-symposium-and-38th-national-registration-13848666735
Doubt it, EPIC E is open label, uncontrolled extension study. This is anecdotal evidence, maybe a passing comment or smile if someone brings up. Cully wont piss off the FDA in any manner by hype. But fact is, EPIC E has been ongoing now for about 4 mos, maybe 50+ enrolled already?? the investigators and patient know how MST188 helped or did not help them.
Plenty of public information available on the net if you look. If you think I post on here all my findings, I'd think again. Plenty of public information available on the net if you look. I like to leave certain findings to surprise.
BlinkX90
Below is a repost: There is now,ZERO doubt in my mind this young boy was enrolled in EPIC-E. This is exactly what investigators like Dr. Kanter are able to see and why I believe she is so excited for Vepoloxamer.
BTW, I was snooping around Facebook/Sickle Cell Unite group this weekend. I went back to Miranda Harden's post/pic on 7/22:
"BEEN HERE SINCE YESTERDAY... AND THEY DID A NEW STUDY ON HIM..AND IT WORKED.. HE IS FEELING NO PAIN.. HE HAS SS....HAVE ANYBODY ELSE TRIED THE NEW MEDICINE? ITS CALLED MST-188"
There was another post with a pic that I initially missed of her sick boy in a hospital bed. The pic shows the MST-118 drip. To me, clearly this young sick boy in VOC, is enrolled in EPIC-E, which is open label and unblinded.
"HE IS FEELING NO PAIN." (within 24 hrs)
I have posted alot on the VERY passionate, Dr.Julie Kanter,Hematologist,from one our biggest EPIC sites, MUSC. BTW MUSC, is also running the open label EPIC-E (Extension) study, which started in June. Both she and the patient know they have received Vepo, so without question, she knows how they have responded. From her posts, I am assuming she is VERY pleased. She has also stated that she is currently treating 400 SCD patients, with 50% of them on HU, up from 30% in the prior year.
Julie Kanter ?@jkw4444 Oct 4
@BlinkX90 will be the beginning of a new era for this living with #sicklecell
So I wanted to see if i could find any quotes from the highly esteemed Dr. Dractman, who treats 450 SCD patients at Rutgers and is one of the biggest enrolling EPIC sites and I found this (courtesy of a very smart bud) from Fall 2014
"In short, no existing therapeutic can abort a VOC once it begins. But that may change soon......"
"We think patients in crisis will see significant improvement, Dr. Drachtman says. "That's a very exciting thing;it actually looks at an active crisis in a different way.
pg 13 http://www.bmsch.org/bmsch/wp-content/uploads/physician-connection.pdf
BlinkX90
Mast Therapeutics management to meet with Canaccord
Meeting to be held in Boston on October 8 hosted by Canaccord.
I have not seen a research piece from Canaccord in ages. I believe they initiated in 2013 with a $3 PT. From memory, either Cowen or Canaccord had an upside PT of $10 if Vepo in cardio indication hits. Maybe we get a reit or even an u/g after 10/8.
BlinkX90
GSCO cooling his jets today in the 49cs, very interesting he showed up the same day as our psycho size bidder..
BlinkX90
Exactly Boss!
BlinkX90
Check out my exchange last night with Dr Julie Kanter, Hematologist at MUSC, one of EPICs MST-188 clinical sites. She also presented at Mast's recent SCD Conf. She is so passionate about finding better treatments for these kids who have basically zip. She seems very hopeful about Vepoloxamer's potential. We will all know soon enough.
http://www.muschealth.org/providerdirectory/Kanter-Washko-Julie
http://scresearch.org/studies/search?utf8=%E2%9C%93&q=sickle+cell&commit=GO
Julie Kanter ?@jkw4444 13h13 hours ago
If you have #sicklecell ask your doctor about participating in research. Research=more medications. Research saves lives #muscsicklestrong
2 retweets 5 favorites
Blink ?@BlinkX90 11h11 hours ago
@jkw4444 http://www.theepicstudy.com/ Vepoloxamer, a real drug, for real life patients! http://www.theepicstudy.com/ $MSTX
0 retweets 3 favorites
Julie Kanter ?@jkw4444 11h11 hours ago
@BlinkX90 will be the beginning of a new era for this living with #sicklecell
BlinkX90
"In a double blind trial, neither the patient nor the physician know who has received MST-188 or placebo. The data are unblinded after the 1st of January 2016. How is it possible to stop early for efficacy?"
The DSMB routinely monitors all clinical trials. Yes Halting a trial for early success is VERY rare,I'm not saying EPIC will be halted, I'm saying they do have a shot as I believe the statistics may line up. ICPT about 2 yrs ago was the last I can remember that got halted by DSMB early for success.It went from like $65 to $465 or something, THAT DAY! LOL On the dark side, VSTM was halted by the DSMB for futility last week and got hammered.
The primary responsibilities of the DSMB are to 1) periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the trial. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm
Rhodey, You have been here since EPIC started in 2013. This has been a Marathon and we are almost in the stadium now where there will be a huge cheering crowd. The posers on this board will be the ones yelling "Hey Hot Dog"!!!
https://twitter.com/search?q=%24mstx&src=typd
See the poster behind Greg? BTW, I'm sure this was a Cully design, since he is is an avid runner and has run marathons.
The stock is acting perfect technically, we have rallied nearly 60% off the 38c low to near 60c on massive volume. We have pulled back the last 2 days on very low volume, I agree with you, if we can get thru last weeks high on volume, we can try that 75c level this week. However, to me this is all just minor short term noise, 50c, 75c, whatever, it's a start but doesn't really excite me. However, I will start to get excited once we break over $1.00 and out of this MASSIVE 4 year base. At $3.50 I will be standing.
Next week we should get some great insight as to where we stand on EPIC, the % on HU being the most important # to me. I still believe there is a shot EPIC is halted early for success, very rare situation, but possible.
G/L
BlinkX90
Rhodey, that was actually GBT who stiffed Mast as well, so both GLYC and GBT are giving MSTX the middle finger.
BlinkX90
I was also thinking about why this urgent SIZE buyer suddenly showed his face, buying aggressively, moving up the bid, not even hiding his size. Why was he buying on 9/29-30 and not on 10/1? My guess is this Fund thinks we will be higher and wanted to be on record for Q3. Also, Goldman has been on the bid, most likely buying for a hedge fund who uses Goldman as his prime broker.
Interesting times ahead.
BlinkX90
I'm expecting a 8k filing shortly, Monday am? laying out the Investor Day Presentation on 10/7. I will post(tweet) as soon as it's filed, s/b very interesting.
BlinkX90
I was listening to the GLYC last Canaccord conf, when the CEO was asked about the competitive landscape, only a Gene Therapy mention, NO mention of Mast, who has the biggest and latest stage Phase 3, interesting.
Also, was looking at the % of patients on HU in their failed phase 2 which read out in 2013. 51% were on HU +their drug, and 70% of the placebo group were on HU, so blended about 60% on HU. Seems to me more evidence that EPIC will have a much higher rate on HU than anyone is modeling.
http://www.glycomimetics.com/wp-content/uploads/2015/01/GMI-1070-201-ASH-primary-FINAL-SLIDES-10DEC2013.pdf
BlinkX90
Great post sir!
TYVM!
BlinkX90
PS BTW Spoke with Ioana about the website (due to the upcoming traffic increase) needing a refresh, addition of "PIPELINE" page, update to reflect "Up and Coming Cardio Co" etc, she's totally on board.
"Please note that updating our corporate website is ongoing and absolutely on our list to finalize this year.
We will need to get through the boatload of 50c penny piker sellers with no conviction or vision who will be moonwalking with their 5c profits.
BlinkX90
Ummm...
Mast Announces Amendment To Loan And Security Agreement With Hercules Technology Growth Capital
- Hercules funds second advance of $10 million; total funding now $15 million
- Amendment allows for deferral or elimination of additional capital raise requirement
http://finance.yahoo.com/news/mast-announces-amendment-loan-security-120000887.html
Commented on SA,
Capital Screen-Obviously you are one of the VERY few who get the MSTX story, too many are all wrapped up in the old ANX management team and the 2 failed drugs. Cully got Vepoloxamer from GSK, for $5m or so, he has hit EVERY enrollment milestone since trial inception in 2013, yet all he gets is "LOL". I'm not going over the EPIC redesign again, I've exhausted that in many posts already. I believe EPIC will smoke the primary and the all important label enhancing 2 secondary endpoints. In fact, I would NOT be surprised if EPIC is halted early for success. I, like the (MSTX team seems to be,) am focused on a robust NDA filing and commercialization plans. The only thing i disagree with you on is the your revenue model and price target. There are >200,000 that present to the ER each year for VOC. (I believe once MST188 is approved even many more SC patients will present to the ER) I also believe the pricing per course will be in the $10-15k range, esp if the label includes the secondary endpoints. I believe peak sales will be at least double that of what you have modeled. As far as the stock price, there are too many factors to estimate where it might go, ie trial halts early for success, Baker Bros adds size, Vepoloxamer-CHF/Stroke gets priced in etc. but I would consider this, look ahead, if EPIC is a success, imagine the emotions surrounding and FDA ADCOM later in 2016? Black children who have not had a new sickle cell treatment in 18 years. MSTX definitely has cult stock potential.
BlinkX90
Bees are starting to buzz. Big bid chaser today and he didn't get his fill.
BlinkX90
#Clueless
It's a different study, different abstract, period. We all know its just pre-clinical, but the point is your wrong again and you just throw chit against the wall to see if it sticks.
I'm not sure if I can think of something more dumber than bashing a stock you supposedly own. My guess is that you bought ANX at 3 or 4 or whatever and got smoked and now you are just a bitter old man hating Mast, where the prior management and failed drugs are long gone.
Foreeeeeeeeeeeeeeeeeeeeeeeeee!
G/L with that Karma.
BlinkX90
Mast Therapeutics: Locked And Loaded Upfront Of Phase III Results
http://seekingalpha.com/article/3537656-mast-therapeutics-locked-and-loaded-upfront-of-phase-iii-results
Finally somebody who has actually done due diligence. I will be adding a few comments to this piece when I have a chance.
BlinkX90
Geez, Stop embarrassing yourself. Do you have any clue how to read an abstract? This is NOT the same abstract from 2013. This is the 3rd different study being presented for Vepo in a model of CHF.
Seriously, maybe time to up your meds or better yet, sell your thousand shares and get back to the Bingo Table.
"We also look forward to discussing our ongoing activities to prepare for vepoloxamer's New Drug Application and our commercialization plans for vepoloxamer in sickle cell disease."
http://finance.yahoo.com/news/mast-therapeutics-host-analyst-investor-120000396.html
Why has he gone DIRECT to making public comments about preparing the NDA and commercialization and skipping EPIC? He doesn't even say preparing the NDA "IF" EPIC is a success. BTW, The lawyers had to sign off on this PR.
BlinkX90
In the past, hydroxyurea was reserved for patients with very severe disease. “Since then, studies have found that hydroxyurea helps patients live longer and have fewer pain crises,” says Glassberg. “The big children’s hospitals like St. Jude’s are now putting babies on hydroxurea starting at nine months — the thinking is that the body will suffer less damage if we can start kids early on this medicine.”
http://m.nydailynews.com/life-style/health/daily-checkup-act-quickly-aggressively-sickle-cell-article-1.2360292
I'm really starting to think the patients enrolled in EPIC on HU+MST-188 concurrently will be much higher than I have previously estimated. In the first failed phase 3, the % was 21, if it had been 30%, the trial on that one metric change alone would have been a success and we know there are at least 4 other major redesigns.
We will know on 10/7
BlinkX90
Focus Ticker: Mast Therapeutics
Mast Therapeutics (NYSEMKT:MSTX) shares jumped nearly 9% on Tuesday to close under $0.50. MSTX shares have struggled to break through despite the potential of its lead product candidate in sickle cell disease and the fact that enrollment in the EPIC trial is progressing well.
On September 15th, MSTX said in a presentation that the EPIC trial is more than 75% enrolled. With vepoloxamer, MSTX is looking to meet a significant unmet need. Vepoloxamer is purified poloxamer and was initially developed by Dr. Robert Hunter, MD, PhD (Distinguished Professor and Chairman, Department of Pathology and Laboratory Medicine, University of Texas Medical School at Houston). A study involving 255 patients did not meet the primary endpoint of reduction in duration of a painful crisis. A post hoc responder's analysis was done and based on the observations from this, MSTX has designed its EPIC trial. MSTX acquired the drug from Dr. Hunter's team in 2011.
The better designed EPIC trial has the potential to be successful and if it is MSTX could bring to the market, a drug with potential peak sales of $720 million. The peak sales estimate is based just on the number of sickle cell cases in the U.S. alone.
The question then is why is MSTX still struggling to breakthrough. In my opinion, investors are remaining on the sidelines because of past failures of MSTX. Mast Therapeutics was formerly known as Adventrx. Adventrx suffered two major setbacks. The first was in 2006 when the company's CoFactor in Phase IIb study failed. In 2010, the company suffered the second setback when its Exelbine, an equivalent to an older cancer drug Navelbine, was rejected by the FDA. These two setbacks have led to questions about MSTX's ability to reach commercialization. However, with vepoloxamer, the company has the best chance to reach commercialization stage.
Recently, Roth Capital analyst Michael Higgins spoke to Key Opinion Leader, Dr. Richard Drachtman. Dr. Drachtman treats 450 sickle cell patients at the Rutgers Cancer Institute of New Jersey. Higgins said in a research note that Dr. Drachtman's comments were in his view supportive of the EPIC outcome.
I believe that MSTX will trade sideways until early 2016. In the first quarter of 2016, the company is expected to report top-line data from the EPIC trial and this is a major upcoming catalyst that could boost the stock price.
http://seekingalpha.com/article/3528206-premarket-biotech-digest-drug-pricing-mast-therapeutics-upside-mylan-perrigo
MSTX Mast Therapeutics To Host Analyst & Investor Day On October 7, 2015
EPIC patient enrollment and blinded demographics, including hydroxyurea use among the study population;
EPIC statistical assumptions versus blinded performance, including stratification factors and primary endpoint;
Initiation of 150-patient, Phase 2 study of vepoloxamer in chronic heart failure;
Progress with two AIR001 Phase 2a studies; and
Overview of commercial opportunity and strategy for vepoloxamer in sickle cell disease.
As a leader in the space, and with less than two quarters until top-line results from EPIC, the largest interventional study ever conducted in sickle cell disease, are announced, we believe this is an opportune time to provide substantive updates on EPIC and our other clinical programs," said Brian M. Culley, the Company's Chief Executive Officer. "We also look forward to discussing our ongoing activities to prepare for vepoloxamer's New Drug Application and our commercialization plans for vepoloxamer in sickle cell disease
"an early stop for efficacy evidence would be great
only a dream?"
Not a dream at all 291/388 are enrolled. This is not a cancer trial where we wait years for an "event". In EPIC SC patients in VOC present at the ER,within 24 hrs are randomized, tracked and the crisis is ultimately resolved. Per protocol, the patient is tracked for 12 days to measure the re hospitalization rate. So that means anyone randomized, let's say by 9/1 is now a statistic. The 1st failed trial with all of its design flaws barely missed hitting statistically significant results after only 250 patients. So what if the DSMB who routinely monitors trials for safety and efficacy just took a look at EPIC and based on that look they halt the trial due to success. A very rare situation indeed, but quite possible here. Imagine MSTX is halted for news pending and the news is that EPIC is halted due to hitting both the primary and secondary end points?
BlinkX90
In the 1st failed study, the % of patients on HU + MST-188 was 21%, my initial guess for EPIC was 30%, now with the comments from the KOL dinner, I'm thinking 30% is a slamdunk and perhaps way higher. If so, by this one trial change alone, EPIC appears to have a very HIGH probability of hitting statistical significance. There are at least 4 other MAJOR trial design changes.(avg age 16-17, etc.) I also believe EPIC hits not only the primary endpoint but both secondaries as well. The Vepoloxmar label should be very strong. I'm hoping the 10/7 R & D gets alot of interest.
G/L
BlinkX90
"the vepoloxamer+HU patients’ mean duration was 26 hours shorter (p=0.02) than the eight hour reduction in the overall group. If all other design elements remained the same as the first Phase 3, the 10% absolute increase in HU usage should in our estimation push the mean duration up two hours to ten. We believe this metric alone would be enough by itself to push the p-value <0.05 in that 255 patient study. "
BTW, Roth just issued a a report from the SCD KOL(Key Opinion Leader) Dinner just held. Some real interesting KEY takeaways. Most notably about the % of patients on HU(Hydroxyurea). If you recall, in the 1st failed MST-118 trial, the rate on concurrent HU + MST-118 was just 21%, if that number had increased to 30%, despite all of the massive design trial probs etc, the result would have been VERY positive. (Patients on HU +MST-118 had time of crisis improved by 3x) According to Julie Kanter, who presented at Mast's SCD conf just held, 50% (FIFTY) of her SC patients were on HU. If you have the most BASIC of statistics knowledge and have looked at the failed trial results+the EPIC design, you will understand how HUGE this ONE piece of information is.
G/L
BlinkX90
Look at a 3 year weekly to see the base that's in place.
BlinkX90
@jkw4444 $MSTX, good thing MST-118 is on the way for these black kids in VOC http://www.nbcnews.com/health/kids-health/black-kids-get-less-pain-medication-white-kids-er-n427056 … #SickleCellAwareness
Julie Kanter ?@jkw4444 4m4 minutes ago
Julie Kanter retweeted BlinkX90
Yes MST-188 is an important med to prove people with #Sicklecell need real treatment for real pain #muscsicklestrong
May want to follow @jkw4444 on twitter:
FYI Dr Kanter, Hematologist at an EPIC site @ MUSC
BlinkX90
I don't think there is a need to "feel for people like Rhodey", appears to be a big boy and it looks like hes been around MSTX for about 3 yrs, so I'd assume he has a cost basis somewhere around here. He's obviously not a daytrader trying to pike this thing for 5c scalps. He's made his bet and is looking for the big prize, that may or may not come within the next 6 mos or so. If he's right he gets paid large, if not and he's holding when EPIC reads out, he gets smoked. BTW, I think there will be plenty of opps to take $$ of the table before EPIC.
MSTX tapped the ATM to the tune of ONLY $2mill in the 1st 6mos of the year, the Hercules loan is in place, Cully has addressed this very nicely, (see last CC) highly unlikely he's tapping it down here at 45c. Yes the stock just just jellyfishes around down here and if you're long and don't have any conviction, you just hate it. If you have done your DD and have conviction and are not a daytrader, the price action down here on very low volume doesn't matter, why should it? If you look at the 3 year weekly, I see a massive base ready to explode out of. If the Funds are going to jump in, maybe they are waiting for the 100% enrolled PR? Maybe they are waiting for R & D day where Cully has alluded he's got info to share,ie % on HU, demographics, "some unblinded data". Most Funds y/e are approaching, maybe they will see the potential here and jump in after their y/e? It just takes one Fund to get the party started. Cully is carefully already preparing for a very potent NDA filing (QT study, EPIC-E, sub studies etc) and is very confident. He has hit ALL enrollment deadlines since 2013. Showtime is fast approaching, this is not for the faint of heart. The road to the promised land is always very bumpy.
G/l
BlinkX90
BTW Dr Kanter, a Hematolgist, MUSC tweeted these:
Julie Kanter ?@jkw4444 Jun 28 Summerville, SC
EPIC sickle cell study by @MastThera will prove what the #scd community can do when we work together. We are SICKLESTRONG. #muscsicklestrong
Julie Kanter ?@jkw4444 Aug 13
Good things happening in #sicklecell and more to come through research. $BLUE $MSTX #muscsicklestrong
FYI, She was a speaker at Mast's big SCD conf last week.
http://www.scdconference.com/about-the-speakers/
MUSC is a clinical site in EPIC
https://clinicaltrials.gov/ct2/show/study/NCT01737814?term=mast+therapeutics&rank=3&show_locs=Y#locn
So a Hematologist on the front line, at one of our EPIC trial locations tweeted those. What could she know to make her sound so positive?? oh EPIC-E started in May, and oh it's unblinded and open label.
BlinkX90
BTW, I was snooping around Facebook/Sickle Cell Unite group this weekend. I went back to Miranda Harden's post/pic on 7/22:
"BEEN HERE SINCE YESTERDAY... AND THEY DID A NEW STUDY ON HIM..AND IT WORKED.. HE IS FEELING NO PAIN.. HE HAS SS....HAVE ANYBODY ELSE TRIED THE NEW MEDICINE? ITS CALLED MST-188"
There was another post with a pic that I initially missed of her sick boy in a hospital bed. The pic shows the MST-118 drip. To me, clearly this young sick boy in VOC, is enrolled in EPIC-E, which is open label and unblinded.
"HE IS FEELING NO PAIN." (within 24 hrs)
BlinkX90
Posted this in response to the latest SA piece comment if interested.
"Dreams of a $5 share price are non sense ($1b MC),this company hardly deserves a MC of $70 million as the next dilutive financing is just around the corner."
SHOCKING! a developmental biotech is raising money and is increasing the o/s shares. How dare they! they are the only biotech that has ever done this.
Since you are so hung up on why a developmental biotech that raises $ and increases o/s shares can't possible move higher, here are a just few examples.
EXEL 1.2 bln mkt cap, 225m shares o/s, drug in very competitive mkt, maybe 200m peak sales. Just history of HORRID financings and a past drug trial failure, stock totally left for the dead, yet recently ran from $1.40 to near $7.
MNKD, Sanofi owns only 1/2 of Afrezza, had Q1 sales of $1.1m, at $4,current mkt cap= $1.7bln, but ran to $10 on hype., 414m shares o/s, good possibility Sanofi dumps them.
ARNA has Takeda as partner, what % of drug do they own 33%? at $2.75 Current mkt cap = $663m mkt cap, ran to $10 on hype, 240 shs o/s, drug is a bomb.
VVUS 104m shs o/s ran to $25+ on hype, drug complete bomb., OREX 125m o/s huge run ditto. Too many other examples to list.
"It's not about the science, it's about the money, and the money has left." "This company is a classic biotech turd of epic proportions."
Over and over again, history has proven biotech stocks can go from zeros to heroes seemingly overnight. Stocks that are hated with unexpected favorable news can and have produced huge oversized gains. MSTX can't do the same? Mast has a very late stage 100% owned phase 3 asset, with a VERY HIGH chance of hitting endpoints in a very "emotional/political" (see DNDN, NTMD) indication + potential huge cardio indications. Fairly clean balance sheet, 12 mos cash, No debt, (esp convert debt,) manageable warrants +. Hercules non dilutive financing in place.
Yes, no argument, the stock has been horrid for years. I believe in the next few months that will all change and contrary to what you believe, to me, it's about the science and I believe the EPIC read out catalyst will bring the money flow in. Of course, I could be wrong , but I believe that the odds favor that will be the case here. I would just love a better argument than "This company is a classic biotech turd of epic proportions" as to why MSTX can't at least have the classic hype run up into a binary event, let alone what the hype will be if EPIC hits and a FDA Panel date is assigned. Your negative sentiment is shared by probably 95% of other traders/investors without them every looking at the possibilities here and I love that. October 7th is R& D day.
BlinkX90
$MSTX 9/3 Update, EPIC now 75% enrolled, Topline Q1 16, no delays, no safety issues
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=10897967-12883-26674&type=sect&TabIndex=2&companyid=91212&ppu=%252fdefault.aspx%253fcik%253d1160308
BlinkX90
Upcoming Catalysts:
9/3 4th Annual SCD Therapeutics Conf ( Mast hosting)
Jonca Bull, MD FDA Speaker
10:00am – 10:20am Sickle Cell Disease Advocacy Achievement Award Congressman Charles B. Rangel (He could be very valuable ie politics, FDA Adcom)
Blue Bird, Global Blood Therapeutics attending
Q3-Inititiation phase 2 Vepoloxamer in CHF
Q3 AIR001 Ph2a results HFpEF patients
10/7 R&D Day (potential updates) (BTW EPIC-E is open label, unblinded study, started in May, hope you get what this means)
Q4 Phase 3 EPIC 100% Enrolled
Q1 2016 Phase 3 EPIC results