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Cynical Trader

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  • Intercept Pharmaceuticals: Elucidating The Ramifications For The Flint Trial [View article]
    Dr. Tran, re: Genfit... I don't understand your concerns about GFT505's safety... have you even looked at GFT505 studies? GFT505 has been taken by over 400 patients to date... with ZERO side effects. Some patients have been on GFT505 for over a year...in every trial all metabolic markers trended positive in a dose dependent manner.

    http://bit.ly/1fFAg1L

    A quote from their P1 study...

    "Considering the excellent tolerance obtained throughout the study (GENFIT press release of November 18, 2008), these activity data suggest for a large efficacy/safety ratio for GFT505. "

    http://bit.ly/1fFAg1O

    BTW - Galactin's NASH drug is administered by IV.. it will never be a mainstream treatment. La Jolla's galactin inhibitor GCS-100 is also an IV drug.

    biocqr
    Feb 7, 2014. 04:24 PM | Likes Like |Link to Comment
  • Benitec's Timetable To Success [View instapost]
    Pannobhaso, I've been following your blog articles and comments. I appreciate your in depth knowledge of Benitec's platform. Question... where can I find data from the NHP studies?
    Feb 3, 2014. 11:06 PM | Likes Like |Link to Comment
  • Why It Could Pay Off To Look At The Big Picture Of Intercept Pharmaceuticals [View article]
    First of all I never said GFT505 would outcompete OCA. I said the results reported so far show that the effects of GFT505 and OCA are similar and in some metrics GFT505 looks better... i.e. HDL & LDL. If your asking me to explain the MOA for PPAR and FXR... I do not have a biochemistry background. Perhaps you could explain why one is better than the other. The PPAR and FXR agonists both effect multiple metabolic pathways... which one will be more efficacious or have the fewest side effects remains to be seen however there is more clinical data on GFT505...there have been more trials, on more patients and with more metabolic marker data.
    Jan 26, 2014. 07:45 PM | 1 Like Like |Link to Comment
  • Why It Could Pay Off To Look At The Big Picture Of Intercept Pharmaceuticals [View article]
    GFT505 is another NASH drug with artherogenic properties that suggests reverse cholesterol transport. GFT505 is being developed by Genfit of Lille France. In P2 trials the metabolic markers of GFT505 are similar or better than Intercept's OCA… GFT505 increases insulin sensitivity, reduces HbA1c, raises HDL-C, lowers LDL, reduces ApoB & triglycerides + excellent safety. Mouse studies also show reversal of liver fibrosis.

    GFT505 is a dual PPAR agonist (alpha/beta). In Oct 2013 the 2nd phase of Genfit's Phase IIB trial enrolled 150 patients in less than one month. Some patients have been on 80 mg/d of GFT505 for over a year with no safety issues.

    Genfit trades on the Paris exch as ALGFT and in the U.S. as GNFTF at about 1/4 the mc of ICPT.
    Jan 26, 2014. 11:29 AM | 1 Like Like |Link to Comment
  • Analysis Of Vical's Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial [View article]
    Not one major pure biotech fund owns a single share of VICL. Not the Bakers, Perceptive, Orbimed, RA, Tang, BVF, Great Point, Deerfield, Ridgeback or Sabby.

    That should tell you something.

    http://bit.ly/13Ac3T7
    Jul 31, 2013. 03:05 PM | 3 Likes Like |Link to Comment
  • MiMedx: All Signals Say 'Sell Now' [View article]
    Take that shorty!

    MiMedx To Exceed High End Of Second Quarter Guidance

    MARIETTA, Ga., July 15, 2013 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company will slightly exceed the $13.5 million high end of its previously communicated revenue range for second quarter of 2013.

    The Company's second quarter of 2013 revenue represents an increase of greater than 175% over second quarter of 2012 revenue, and for the six months ended June 30, 2013, MiMedx revenue increased by more than 190% over its revenue for the first six months of 2012. The Company reported that the second quarter of 2013 marks the 7th consecutive quarter in which MiMedx has met or exceeded its revenue guidance.

    The Company also increased its guidance for the lower end of its full year 2013 revenue range. MiMedx reported that it now expects the Company's 2013 full year revenue to be in the range of $54 million to $60 million. Where revenue falls within this range is dependent on the reimbursement approval of the three remaining Medicare Contractors.
    Jul 15, 2013. 02:05 PM | Likes Like |Link to Comment
  • Avita Medical's Breakthrough Device Nearing U.S. Approval [View article]
    Jason - I'm surprised you didn't mention MDXG's Epifix as a competitive skin substitute for burns and chronic wounds. Epifix has superior healing properties compared to Apligraph and Dermagraft and requires no special handling or cold storage and has a shelf life of 5 years at room temp. EpiFix doesn't require the pre-processing like AutoLogel and ReCell... you just cut it into the desired size then apply. How do you see ReCell stacking up against EpiFix in chronic wound care... I can see the advantage for ReCell in burns but it would be tough to beat EpiFix for chronic wounds.
    Jun 18, 2013. 03:42 PM | Likes Like |Link to Comment
  • Acadia Has A Silver Lining In Its Playbook [View article]
    Ridgeback, Perceptive, Deerfield, Great Point and Tang are others.
    Jun 9, 2013. 10:55 AM | Likes Like |Link to Comment
  • Acadia Has A Silver Lining In Its Playbook [View article]
    Tang, Deerfield and Ridgeback as well.
    Jun 9, 2013. 10:45 AM | Likes Like |Link to Comment
  • Acadia Has A Silver Lining In Its Playbook [View article]
    Dafna is another... Perceptive is a long/short fund so I always keep an eye on them. They sold out their ACAD last Q but at least they didn't go short - lol.
    Jun 7, 2013. 11:36 AM | 1 Like Like |Link to Comment
  • Acadia Has A Silver Lining In Its Playbook [View article]
    Excellent article. Other than Baker Bros and RA, who are the other pure bio funds?
    Jun 6, 2013. 11:38 PM | Likes Like |Link to Comment
  • Lpath's Q3 Filing Shines The Way For A Catalyst Filled 2013 [View article]
    >The wet AMD indication is significant with a large market group targeted. The worldwide incidence is about 30-50 million people with about 8 million in the United States alone. <

    This is incorrect. The prevalence of wet AMD is about 10-15% of overall AMD. In the U.S. it's estimated at 1.7M.
    Nov 30, 2012. 09:37 AM | 1 Like Like |Link to Comment
  • Giant Intuitive Surgical Moves Into New Types Of Surgeries [View article]
    The Firefly system is an add-on device supplied by Novadaq - NVDQ. Novadaq entered into partnerships with ISRG in 2009 and KVC/Lifecell in 2011 for perfusion assessment in breast reconstruction and wound care. NVDQ will be marketing a stand alone device called Pinpoint beginning in 2Q 2013 for perfusion imaging in colorectal surgery. NVDQ is also developing multiple imaging agents for nerve, SNL and various tumors. I consider NVDQ to be an early stage ISRG-like company.
    Nov 6, 2012. 01:45 AM | Likes Like |Link to Comment
  • Novadaq Highlights Game Changer For The OR [View article]
    Len... the symbol is NVDQ. Novadaq listed on the Nasdaq back in March. This is a very exciting company with an expansive menu of applications. It will be interesting to see how the PINPOINT launch unfolds next year however the real fun begins when nerve and tumor imaging are approved which will drive hardware and kit sales exponentially.
    Oct 18, 2012. 12:45 AM | Likes Like |Link to Comment
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