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Post by iamaverb on Sept 2, 2014 13:00:38 GMT
I saw an early presentation by this company while waiting for Gary Rabin to speak at the wind in Vegas almost a year ago. I was impressed so I began buying shares while I sat in the audience. This company has multiple Phase II and III trials in this multi-billion plus market underway and TLD of the trials are expected to come out by the end of the year.
Alcobra Announces Enrollment of First Patient in Phase IIb
Clinical Trial of MDX in Adolescents With ADHD
Tel Aviv, Israel – September 2, 2014 – Alcobra Ltd. (NasdaqGM: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that the first patient has been enrolled in a Phase IIb study of MDX in adolescents with ADHD. The trial is expected to complete enrollment and report topline data by the end of 2014.
The Phase IIb trial is a multi-center, randomized, double-blind, fixed dose study designed to evaluate the safety and tolerability of MDX in up to 82 adolescents (aged 13-17) with predominantly inattentive ADHD (PI-ADHD). The primary endpoint will be safety, tolerability and pharmacokinetics. Secondary endpoints include change in efficacy measures such as TOVA (Test of Variables of Attention), Wechsler Intelligence Scale for Children (WISC-IV) subtests, and working memory and processing speed. ClinicalTrials.gov Identifier: NCT02189772
About Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric condition. Once believed to only affect children, ADHD is now known to persist into adolescence and adulthood in a sizeable number of cases. Key symptoms of ADHD include inattention, hyperactivity and impulsivity.
According to the Centers for Disease Control, about 9% of children in the U.S. meet criteria for ADHD with similar numbers reported in other countries. Although boys are more commonly diagnosed, ADHD is also common in girls who often go undiagnosed. Approximately 4-5% of adults worldwide are affected with ADHD, yet most adults with ADHD remain undiagnosed and untreated. There is no known cause of ADHD, however studies suggest that genetics may play a role.
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Post by stemman on Sept 6, 2014 17:02:40 GMT
What is ADH.... Look, a squirrel!
(could not refrain from plagiarizing it from "Teh Interwebz")
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Post by iamaverb on Sept 9, 2014 14:52:45 GMT
Good volume today. Phase III results soon along with two other PII trials underway.
With Phase III topline data on the FDA calendar for review on September 30th, this could be a September to remember for ACTC/ADHD
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Post by iamaverb on Sept 22, 2014 13:26:45 GMT
Alcobra (ADHD) October call option implied volatility is at 340, December is at 243; compared to its 15-week average of 190 according to Track Data, suggesting large price movement into Dr. Yaron Daniely, president and CEO of Alcobra(ADHD) saying, "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
If these results are positive as management is predicting, I see a double play in the next inning.
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Post by lanzapaste on Sept 22, 2014 15:39:39 GMT
This thing was an absolute steal in the $16's a week ago. If Ph3 results are as good as the company has hinted at, it'll be a steal in the $19's this week.
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Post by JHam on Sept 22, 2014 16:32:43 GMT
Alcobra (ADHD) October call option implied volatility is at 340, December is at 243; compared to its 15-week average of 190 according to Track Data, suggesting large price movement into Dr. Yaron Daniely, president and CEO of Alcobra(ADHD) saying, "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
If these results are positive as management is predicting, I see a double play in the next inning. Nice job guys, I am pulling for ya! Hopefully there are no surprises when the data is unblinded. |
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Post by lanzapaste on Sept 22, 2014 16:57:04 GMT
Thanks Jham, yeah Verb pointed out this stock a long, long time ago and I've done well in it since.
As far as the unblinding goes, as stated in an earlier conference Alcobra held, there has never been an unsuccessful Ph3 trial in a study of ADHD where the previous Ph2 was a success so we'll hope that trend continues. If anything, this company has been a real eye opener as to how professional and efficient a well designed clinical trial can be run, they have just flown through it.
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Post by lanzapaste on Sept 24, 2014 20:07:39 GMT
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Post by lanzapaste on Sept 29, 2014 16:45:54 GMT
Getting slaughtered today $16.10 -3.37 (-17.58%) during the week of expected results, very interesting. Is this people with knowledge of negative results getting out beforehand, or is this blatant manipulation to shake some people out before good results are shared?
It's getting taken down hard and fast on above average volume, very difficult to determine the true cause but it looks like some panic selling is taking place. Should have an answer to my question in about a week from now.
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Post by stemman on Oct 7, 2014 9:39:33 GMT
What do you guys think about the placebo anomaly and the subsequent decision to remove the data that denies statistical significance? More importantly, what do you reckon the FDA will have to say about it?
To our members who are invested - really sorry about the crash; there may still be hope, depending on the FDA's position re. the placebo anomaly. I got lucky, as I did ponder getting in at some point.
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Post by JHam on Oct 7, 2014 12:57:25 GMT
What do you guys think about the placebo anomaly and the subsequent decision to remove the data that denies statistical significance? More importantly, what do you reckon the FDA will have to say about it? To our members who are invested - really sorry about the crash; there may still be hope, depending on the FDA's position re. the placebo anomaly. I got lucky, as I did ponder getting in at some point. stemman, I'll repeat your sentiments to those who were in this one. Biotechs are scary. You just never know what is going to happen once data is unblinded. I almost got in as well, but decided to stay away. That said, it was 4 patients out of 300. I am more curious to hear what the company says about why they didn't include them than the FDA. It reeks of management trying to be sneaky, but I'll reserve judgment until I hear further. If they have a god explanation, the PPS could totally bounce back. It's just dumb in my opinion that they would try to release results this way. Of course it was going to crash. |
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Post by mycargoesfast on Jan 9, 2015 19:01:52 GMT
This is why I will never understand the stock market. 6.5 million share dilution, @ $4/share and the stock goes up 35% to $5.71?  ?? What am I missing? Alcobra Ltd. Prices Public Offering of Ordinary SharesFont size: A | A | A9:06 AM ET 1/9/15 | GlobeNewswire RELATED QUOTES 1:44 PM ET 1/9/15 Symbol Last % Chg ADHD 5.71 34.35% Quotes delayed at least 15 minutes Alcobra Ltd. (Nasdaq:ADHD) announced the pricing of its previously announced underwritten public offering of 6,500,000 ordinary shares at an offering price of $4 per share. Gross proceeds from the sale of the shares by Alcobra before underwriting discounts and commissions and other offering expenses are expected to be approximately $26 million. The offering is expected to close on January 14, 2015, subject to customary closing conditions. In connection with the offering, Alcobra has also granted the underwriters a 30-day option to purchase up to an additional 15% of the ordinary shares offered to the public to cover over-allotments, if any. Alcobra is developing MDX, a proprietary non-stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and other cognitive disorders. Alcobra plans to use the net proceeds from the offering to fund its future clinical development program and for general corporate purposes. Piper Jaffray & Co. is acting as the sole manager. The shares are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-197411) filed pursuant to the Securities Act of 1933, as amended, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement related to the filing will be filed with the SEC and will be available on the SEC's website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924 or by e-mail at prospectus@pjc.com |
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?? What am I missing?