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 Post subject: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 12:44 
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奇股, images/smilies/icon_mrgreen.gif, sarcasm.

记录生动的反面例子


Last edited by sunnyday on 1/5/18 13:14, edited 2 times in total

 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 12:44 
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first of many images/smilies/icon_mrgreen.gif

KALA


http://investors.kalarx.com/phoenix.zhtml?c=254596&p=irol-newsArticle&ID=2325083

Kala Pharmaceuticals Announces Topline Results for Two Phase 3 Trials (STRIDE 1 and STRIDE 2) of KPI-121 0.25% in Dry Eye Disease
  • Statistical significance achieved for the primary sign endpoint,        conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 1        (p<0.0001)
  • Statistical significance achieved for the primary sign endpoint,        conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 2        (p<0.0001)
  • Statistical significance achieved for the primary symptom endpoint,        ocular discomfort severity at Day 15 in the ITT population, in STRIDE        1 (p<0.0001)
  • Ocular discomfort severity at Day 15 in the ITT population showed        improvement but did not reach statistical significance in STRIDE 2        (p=0.1298)
  • Statistical significance for ocular discomfort severity at Day 15        in patients with more severe baseline discomfort was achieved in        STRIDE 1 (p=0.0008), with a trend towards a treatment effect        (p=0.0799) in STRIDE 2
  • Positive treatment effects observed for ocular discomfort severity        in the ITT population at Day 8, a key secondary endpoint in both        STRIDE 1 (p=0.0011) and STRIDE 2 (p=0.0408)
  • KPI-121 0.25% was well-tolerated with elevations in IOP similar to        placebo
  • Conference call today at 8:00 AM Eastern Time

WALTHAM, Mass.--(BUSINESS WIRE)--Jan. 5, 2018--      Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced topline      results from its two Phase 3 clinical trials, STRIDE 1 and STRIDE 2      (STRIDE - Short Term Relief In Dry Eye),      evaluating the safety and efficacy of KPI-121 0.25% versus placebo in      patients with dry eye disease.   

      In the STRIDE 1 trial, statistical significance was achieved for the      primary sign endpoint of conjunctival hyperemia change from baseline to      day 15 in the ITT population (p<0.0001) and the primary symptom endpoint      of ocular discomfort severity change from baseline to day 15 in the ITT      population (p<0.0001). Statistical significance was also achieved for a      second pre-specified primary symptom endpoint of ocular discomfort      severity change from baseline to day 15 in patients with more severe      baseline ocular discomfort (p=0.0008). Statistical significance was not      achieved for a second pre-specified primary sign endpoint, inferior      corneal staining change from baseline to day 15 (p=0.1128). A positive      treatment effect for ocular discomfort was also observed in the ITT      population at day 8 (p=0.0011).   

      KPI-121 was well tolerated in this trial with the most common adverse      event in STRIDE 1 being instillation site pain, which was observed in      6.1% of patients in both the KPI-121 treatment group and the placebo      group. The only other adverse event reported by greater than 1% of      patients was eye irritation, which was reported in 1.1% of patients on      KPI-121 vs. 1.5% of patients on placebo. Elevations in IOP, a known side      effect with topical corticosteroid administration, were similar between      the two groups with 0.4% in the KPI-121 group experiencing an increase      in IOP of 5 mm of mercury (mmHg) or greater resulting in an IOP of 21      mmHg or greater compared to 0.4% in the placebo group.   

      In the STRIDE 2 trial, statistical significance was achieved for the      primary sign endpoint of conjunctival hyperemia change from baseline to      day 15 in the ITT population (p<0.0001). Statistical significance was      not achieved for the primary symptom endpoint of ocular discomfort      severity change from baseline to day 15 in the ITT population      (p=0.1298), although a positive treatment effect was observed at day 8      (p=0.0408), a key secondary endpoint. A trend towards a positive      treatment effect was observed for ocular discomfort severity change from      baseline to day 15 in the patients with more severe baseline ocular      discomfort (p=0.0799), which was a key secondary endpoint in this trial.      KPI-121 was well tolerated in this trial with instillation pain being      the most common adverse event In STRIDE 2 as reported by 5.7% of      patients in the KPI-121 treatment group vs. 4.4% in the placebo group.      The only other adverse event reported by greater than 1% of patients was      blurred vision, which was reported in 0.2% of patients on KPI-121 vs.      1.3% of patients on placebo. Elevations in IOP were similar between the      two groups with 1.1% in the KPI-121 group experiencing an increase in      IOP of 5 mmHg or greater resulting in an IOP of 21 mmHg or greater      compared to none in the placebo group.   

“We are pleased with the positive topline results of STRIDE 1, in which      KPI-121 demonstrated statistically significant improvements in primary      sign and symptom endpoints and are encouraged with the results in STRIDE      2, which showed statistical significance for the primary sign endpoint.      Although we did not achieve statistical significance for the primary      symptom endpoint in STRIDE 2, we did observe a strong trend towards a      positive treatment effect in symptoms in more symptomatic patients, for      which we achieved statistical significance in STRIDE 1,” said Mark      Iwicki , Chief Executive Officer of Kala Pharmaceuticals. “We will      continue to analyze the results of both Phase 3 trials and the totality      of the data from all 3 trials conducted to date and expect to discuss      our clinical program with the FDA. We believe that our preliminary,      unaudited December 31, 2017 cash balance of approximately $114 million      puts us in a strong position as we maintain our focus on moving this      program forward to serve patients with dry eye disease.”   

The two Phase 3 clinical trials were each multicenter, randomized,      double-masked, placebo controlled, parallel-arm studies comparing      KPI-121 to placebo each dosed four times a day (QID) for 14 days.      Subjects who met initial screening and inclusion/exclusion criteria      underwent a 2-week run-in period with placebo dosed in each eye QID for      14 days. Subjects who continued to meet inclusion and exclusion criteria      after the run-in were randomized to either KPI-121 or placebo. A total      of 918 patients were randomized in STRIDE 1 and 909 patients were      randomized in STRIDE 2. Ocular discomfort severity was graded daily by      the patient over the entire course of the trial using a visual analog      grading scale recorded in a patient diary.

WALTHAM, Mass.--(BUSINESS WIRE)--Jan. 5, 2018--      Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company      focused on the development and commercialization of product candidates      using its proprietary mucus-penetrating particle (MPP) technology, today      announced that the New Drug Application (NDA) for INVELTYSTM      (KPI-121 1%), a topical twice-a-day product candidate for the treatment      of inflammation and pain in patients who have undergone ocular surgery,      has been accepted for review by the United States Food and Drug      Administration (FDA). The FDA, in its 74-day letter, indicates that the      application is sufficiently complete to permit a substantive review and      has set a target action date under the Prescription Drug User Fee Act      (PDUFA) of August 24, 2018

Presentation at the 36th Annual J.P. Morgan      Healthcare Conference

Mark Iwicki , Chairman and Chief Executive Officer of Kala, will provide      a corporate update on Monday, January 8, 2018 at 11:30 AM PT,





 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 13:02 
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Joined: 8/8/10 22:40
Posts: 1612
kala 我有啊 就想最坏结果 即使是imixed也会比二期好,没想到跌这么多,不打算加了,没信心了


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 13:17 
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Joined: 12/4/09 19:51
Posts: 3243
You should have sold it long long ago, such as on Nov 27, 2017. IMHO, one should not buy OR buy and hold a stock whose 50 EMA is over 20 EMA. Chart:
http://schrts.co/ERxfio
sunnyday wrote:
kala 我有啊 就想最坏结果 即使是imixed也会比二期好,没想到跌这么多,不打算加了,没信心了


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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 14:08 
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Joined: 11/15/09 14:44
Posts: 1951
小药股很多时候没法按照TA来做,太容易被操纵


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 14:15 
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Joined: 11/15/09 14:44
Posts: 1951
对这类药物,fda要求四个endpoint都要meet,Kala的临床结果其中有一个没有达标


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 16:37 
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Joined: 8/8/10 22:40
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谢谢各位老师,无论ta, fa ,fda 什么a 都学习了都感谢 ! 难过了一天 晚饭前记下来 否则就忘了 真猪啊


Last edited by sunnyday on 1/5/18 18:50, edited 1 time in total

 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 17:43 
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Joined: 11/15/09 14:44
Posts: 1951
别难过,问呆哥私信要一个十倍的pick 8-)


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 19:00 
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koi wrote:
别难过,问呆哥私信要一个十倍的pick 8-)
@dear dls,至少1 倍的pick 就可以了,还有人肉一下这个kls,看他的笑 就心慌。thx a lot


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 19:22 
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Posts: 1612
kala 出水希望是有的,我不说 否则你们听不懂 还会说我思想太复杂。我继续美梦。

其实我早上盘前看到news了,看到当时是17 左右,觉得没事 才没管 忙着跑中概股呢 等再看这个己经跌得太多了 大意了。还有昨天早上3左右买的cnet 4 多就跑了 出去玩雪了 等回来看见cnet涨那么多 我都哭了 还说是冻哭的。我就是典型的穷人小散啊 有点赚就欢天喜地漂了 亏的水下8k米 都挺着


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/5/18 19:38 
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Joined: 11/15/09 14:44
Posts: 1951
有信心就好,就怕墙头草


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/9/18 23:22 
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https://www.sec.gov/Archives/edgar/data ... -index.htm


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/12/18 21:35 
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2018-01-10,10% Owner,ORBIMED ADVISORS LLC ,买入,170338普通股, $12.83 。

2018-01-11,10% Owner,ORBIMED ADVISORS LLC ,买入,41700普通股, $13.65 .

2018-01-12,10% Owner,ORBIMED ADVISORS LLC ,买入,28446普通股, $15.40.


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/12/18 21:39 
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1/16/2018 IPO lock-in period expiration


 
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 Post subject: Re: 奇股共欣赏 疑惑相与析
PostPosted: 1/25/18 00:35 
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Joined: 8/8/10 22:40
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2018-01-12,10% Owner,ORBIMED ADVISORS LLC ,买入,38354普通股, $14.50

2018-01-19,10% Owner,ORBIMED ADVISORS LLC ,买入,74931普通股, $14.95

2018-01-22,10% Owner,ORBIMED ADVISORS LLC ,买入,75000普通股, $14.98

2018-01-23,10% Owner,ORBIMED ADVISORS LLC ,买入,4363普通股, $14.99

2018-01-24,10% Owner,ORBIMED ADVISORS LLC ,买入,64637普通股, $14.91


 
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