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  • Behind The Scenes With Dream Team, CytRx And Galena [View article]
    Fascinating piece, appreciate the investigative approach.
    Mar 13 10:18 AM | 7 Likes Like |Link to Comment
  • Fecal Transplants Might Become A Threat For Cubist's Fidaxomicin Sales And The CVR [View article]
    Aetna has some good commentary on it here and references. I would say there needs to be more trials before making conclusions off of relatively small studies done thus far.

    "Aetna considers fecal bacteriotherapy medically necessary for persons with Clostridium difficile infection, with infection confirmed by a positive stool test for C. difficle toxin, that has recurred following at least one course of adequate antibiotic therapy (10 or more days of vancomycin at a dose of greater than or equal to 125 mg four times per day or 10 or more days of metronidazole at a dose of 500 mg three times per day). Aetna considers fecal bacteriotherapy experimental and investigational for all other indications."

    http://bit.ly/OgM9nF
    Feb 20 10:15 PM | Likes Like |Link to Comment
  • Forthcoming Clinical Trial Results Could Push Prana Shares Even Higher [View article]
    Trial failed all real secondary endpoints. The company along with Dr Tanzi continue to spin the results.

    The 'primary' efficacy endpoints was a measure composed of 7 different values, then they made up 3 different z-score tests. Only one was successful.

    Quote:
    There was a statistically significant improvement in performance on the Trail Making Test Part B (as illustrated in the graph), in the PBT2 250mg group compared to placebo at both 12 (p<0.001) and 26 weeks (p=0.042).

    "Main Composite Cognition z-score and Exploratory Composite Cognition z-score. No statistically significant changes."

    Read towards the bottom now on secondary endpoints, of which are legitimate endpoints. No effect on biomarkers either.

    "No significant changes were seen in motor, functional, behavioural or global assessments in either PBT2 treatment group compared to placebo over the 26 week treatment period."

    http://bit.ly/1gfabHi
    Feb 18 04:15 PM | Likes Like |Link to Comment
  • Forthcoming Clinical Trial Results Could Push Prana Shares Even Higher [View article]
    Theyve been doing it since failed data with PBT1 in 2003. Pushed forward PBT2 even though there was little data suggesting it worked.

    Good example of their hilarity. Shockingly, nothing ever came of these meetings.

    "Prana Responds to Press Comments on Visits by Pharmaceutical Executives

    MELBOURNE, AUSTRALIA -- (MARKET WIRE) -- 03/04/08 -- Prana Biotechnology Limited (NASDAQ: PRAN) (ASX: PBT), has become aware of certain comments which appeared in today's press which have followed on from the release of 26 February 2008 when Prana announced the successful outcome of its Phase IIa Clinical Trial of PBT2 in Early Alzheimer's Disease. The comments relate to a visit to Prana by pharmaceutical company executives and expressed the belief that Prana was engaged in confidential commercial discussions to fund further trials of PBT2."
    Feb 2 01:48 AM | Likes Like |Link to Comment
  • Forthcoming Clinical Trial Results Could Push Prana Shares Even Higher [View article]
    Do some due diligence. Funny how the company than canned this "definitive" study to do a 40 patient study which is very far from definitive. Trial results will be ambiguous and executives will move forward regardless.

    "Prana to Commence Phase IIb Trial on PBT2

    525 Alzheimer's Disease Patients to Be Treated for 12 Months

    NEW YORK, NY -- (Marketwire) -- 04/20/10 -- Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that it is finalising plans to commence a definitive Phase IIb trial of its lead Alzheimer's disease drug, PBT2, before the end of this year.

    The Phase IIb trial will involve 525 patients with mild to moderate Alzheimer's disease. Treatment will be over a period of 12 months, with the key performance measure being cognition (including ADAS Cog* and Executive Function tests from the NTB*). The trial, a double blind placebo controlled study, will test the efficacy of 2 doses of PBT2 (250mg and 100mg). "We are excited by this protocol because we already know how patients benefited from a 250mg dose of PBT2 in just 12 weeks, so we are confident the benefit will be even stronger and more pronounced over a 12 month trial," said Mr. Kempler. "This trial is all about cognition and helping patients."
    Feb 1 07:52 PM | Likes Like |Link to Comment
  • Forthcoming Clinical Trial Results Could Push Prana Shares Even Higher [View article]
    It missed on all endpoints(MMSE and ADAS-Cog).

    Company mined one of the 6 components of the NTB.
    Jan 27 10:06 PM | Likes Like |Link to Comment
  • Forthcoming Clinical Trial Results Could Push Prana Shares Even Higher [View article]
    $600 billion , why not $600 trillion? Actually market size is about $10-11B or 60 times smaller than you claim.

    http://bit.ly/1eXthSZ

    PBT2 will not change this either. Read some actual reviews of their data.

    "In the second trial a successor compound, PBT2, was compared with placebo in 78 participants with mild Alzheimer's dementia; all were included in the intention-to-treat analysis. There was no significant difference in the Neuropsychological Test Battery (NTB) composite, memory or executive scores between placebo and PBT2 in the least squares mean change from baseline at week 12. However, two executive function component tests of the NTB showed significant improvement over placebo in the PBT2 250 mg group from baseline to week 12: category fluency test (2.8 words, 95% CI 0.1 to 5.4; P = 0.041) and trail making part B (-48.0 s, 95% CI -83.0 to -13.0; P = 0.009). In the executive factor Z score, the difference in least squares mean change from baseline at week 12 for PBT2 250 mg compared with placebo was 0·27 (0·01 to 0·53; p=0·042).There was no significant effect on cognition on Mini-Mental State Examination (MMSE) or ADAS-Cog scales. PBT2 had a favourable safety profile."

    - See more at: http://bit.ly/1eXth5C
    Jan 26 03:31 PM | Likes Like |Link to Comment
  • Retrophin - A Peek Under The Veneer Of 2 Recent Additions [View article]
    CEO Martin Shkreli posted a thoughtful response

    http://bit.ly/1eZpDql
    Jan 24 08:09 PM | Likes Like |Link to Comment
  • Oncolytics Biotech, Inc.: An Intro To These Next Few Crucial Weeks [View article]
    Guess we were right after all...
    Jan 3 01:54 PM | 1 Like Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    BRCA testing fee cut in half by Medicare, no error either. Now $1438 vs prior 3k.

    Despicable behavior by management not confirming this weeks ago.

    http://go.cms.gov/1bmX6KO
    Dec 29 03:10 PM | Likes Like |Link to Comment
  • A Look At ImmunoCellular Therapeutics Just Prior To Interim Data [View article]
    Trial fails on OS, p=0.58.
    Dec 11 04:11 PM | Likes Like |Link to Comment
  • How Do You Fake 7 Of 16 Five-Year Glioblastoma Survivors? [View article]
    Trial fails on OS, p=0.58. Imagine a big surprise to the author?
    Dec 11 04:10 PM | Likes Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    The CMS just cut their reimbursement rate by ~50%. Not a positive development going forward.
    Dec 5 01:43 AM | 1 Like Like |Link to Comment
  • Celldex: Tune In For Monday's Conference Call On Rindopepimut [View article]
    Not sure batting 2/25 is a good outcome
    Nov 22 02:09 PM | Likes Like |Link to Comment
  • Horizon Pharma Continues Cash Burn And Dilution [View article]
    Impressive they were able to turn this around. I do wonder how they will sell Vimovo with Nexium going generic in April'14.
    Nov 20 11:33 AM | Likes Like |Link to Comment
COMMENTS STATS
388 Comments
63 Likes