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Alp Bugra Basat

 
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  • Retrophin: An Attractive Short Candidate Due To Numerous Red Flags [View article]
    I got a suggestion for you: Never write about biotech stocks.
    May 29 09:08 PM | 3 Likes Like |Link to Comment
  • Analysis Of Vical's Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial [View article]
    So, you now know that I have a scientific basis :)
    Aug 12 11:21 AM | 2 Likes Like |Link to Comment
  • Analysis Of Vical's Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial [View article]
    WOHOOOOOOOOOOOOOOOOOOO...

    http://on.mktw.net/11Y...

    WHAT'S UP BABY?
    Aug 12 06:19 AM | 2 Likes Like |Link to Comment
  • Analysis Of Vical's Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial [View article]
    Well, yet another crash is now coming. Cancer vaccine is a hype, for now. FYI.
    Jul 31 08:26 AM | 2 Likes Like |Link to Comment
  • Invest In Greece Because The Turnaround Has Already Started [View article]
    I agree, but also any kind of real-estate in Greece would be a good investment. Turn around is soon.
    May 13 10:49 AM | 2 Likes Like |Link to Comment
  • There Might Be No Chance For Amicus' Migalastat As A Monotherapy [View article]
    I am on holiday sorry for my late response:

    http://1.usa.gov/13qgiEU
    http://bit.ly/13qgiEW

    GL-3 is highly variable among Fabry patients, because lots of different mutations cause Fabry. Some mutations don't even cause an elevated GL-3. GL-3 level is roughly associated with clinical severity but it is the marker we have, for now.

    "Unexpected" is my focus in this article. You can expect unexpectedly low levels of GL-3 in fabry disease unless you classify patients according to their mutation type.

    I agree it is hard to lower GL-3 when baseline is near 0. But you need to show something to FDA, you cannot simply say that sorry, my patients got low levels of GL-3. That's my point.

    Moreover, different mutations, variability of GL-3 levels, variability of response to migalastat (given the mutation heterogeneity in trial)... and you need to get a statistical difference. I am not even talking about heterogeneity in metabolism of migalastat (shortly pharmacokinetics of migalastat), I mean CYP differences. Pharmacokinetic variability can occur in any trial, but think about it along with other variabilities.

    So in order to convince FDA, you need to show statistical difference. I adore the science behind migalastat but unfortunately with that clinical trial design, it is more likely to fail as a monotherapy.

    Best wishes,
    Sep 6 07:50 PM | 1 Like Like |Link to Comment
  • Agenus: Assessing Stock Prospects After MAGE A-3 Cancer Vaccine Misses Primary Endpoint In Melanoma [View article]
    Thanks Adam! I am on holiday now and I was thinking how I can explain it very shortly.

    For those who might be interested in science behind it: Creating a strong immune response against self-human tissue is extremely hard (even harder if it is a cancer tissue). My opinion is that if immunologists can solve the autoimmunity puzzle completely, then it might be possible to create an artificial autoimmunity against cancer tissue. Needs very long basic science work on autoimmunity!

    We are good at stimulating immune cells against bacteria and virus but a long-term hard work is still needed to stimulate immune cells against a cancer by a vaccine.
    Sep 6 07:13 PM | 1 Like Like |Link to Comment
  • Agenus: Assessing Stock Prospects After MAGE A-3 Cancer Vaccine Misses Primary Endpoint In Melanoma [View article]
    Cancer Vaccine is a hype, for now. As I said many times before Vical's failure.
    Sep 5 03:24 PM | 1 Like Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    People will watch ad, and they will ask their oncologist about it. The opinion of oncologist will be of great value for the patients since majority of the patients cannot understand such an advanced type of cancer treatment. Thus, opinions of oncologists will determine the Provenge sales.
    Apr 11 06:37 PM | 1 Like Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    I warned everybody here... They are NOT professional investors. One member of the EFS so called investment:

    http://linkd.in/16NqtDg

    english lang. undergrad...

    spread the word and inform SA editors please. SA should have a credibility...
    Apr 11 03:03 PM | 1 Like Like |Link to Comment
  • Phase II Calamity Dooms Ohr's Eye Drops [View article]
    I would be much more confident to say that there is some clinical activity after I see the error bars and the effect of these 2 patients on mean values in that graph: http://bit.ly/1jxsUPw

    http://bit.ly/1iQ9V7L ---------------->62 patients

    http://bit.ly/1iQ9V7N ---------------> 60 patients
    Jun 28 09:42 PM | Likes Like |Link to Comment
  • Ohr Pharma: A Pure 2014 Catalyst Play With Large Potential [View article]
    Steve take a look at my first comment above :)
    Jun 28 07:40 PM | Likes Like |Link to Comment
  • Retrophin: An Attractive Short Candidate Due To Numerous Red Flags [View article]
    I am pretty sure author is bullish on Galena, Northwest Bio, Inovio and Agenus, right?
    May 28 11:13 PM | Likes Like |Link to Comment
  • There Might Be No Chance For Amicus' Migalastat As A Monotherapy [View article]
    http://bit.ly/RAJ0k0

    You can read the summary of this story and press release above.

    Press release says:

    "The primary endpoint in Study 011 analyzed the percent change in kidney interstitial capillary GL-3 inclusions from baseline to month 6 (responder analysis with a 50% reduction threshold). As previously reported , the variability and low levels of GL-3 at baseline contributed to a higher-than-anticipated placebo response at month 6. Following the unblinding of the 6-month data, and while still blinded to the 12-month data, Amicus identified the mean change in GL-3 as a more appropriate way to control for the variability in GL-3 levels in Study 011 and to measure the biological effect of migalastat.

    Amicus analyzed and previously reported the mean change in GL-3 from baseline to month 6 as a post-hoc analysis, including a subgroup analysis in patients with GLP HEK amenable mutations that further supports use of the GLP HEK assay in predicting responsiveness to migalastat. Following a Type C Meeting with the U.S. Food and Drug Administration, Amicus revised the Statistical Analysis Plan to pre-specify the primary analysis at month 12 as the mean change in GL-3 in patients with GLP HEK amenable mutations."

    It basically says we did post-hoc analysis on 011 data and find out that if you took mean change in GL-3 from baseline as a measure then you'll get statistically significant results. And they are going to run a trial with such statistical approach.

    So only change is statistical method. Let's forget about everyting ask this question: This drug really help these patients?

    Press release does not say anything about clinical results except "Kidney function (estimated glomerular filtration rate (eGFR), iohexol mGFR) remained stable over 18-24 months" Is that statistically significant? We do not know...

    FDA already said that they have a failure in their hands and changing analysis method -my guess- won't augment this view unless they can show a statistically significant clinical improvement.

    Moreover another company Vertex is also chasing similar approach, what Amicus is now using, inhibitor mediated ER degredation rescue. Amicus' failure also makes me feel very unconfortable with Vertex's VX-809, particularly after they have switched primary and secondary endpoints which you can read here: http://bit.ly/RAJ2sc

    Take home message: Inhibitor mediated ER degredation rescue has a long way to go, like siRNA technology...
    May 10 07:46 PM | Likes Like |Link to Comment
  • NeoStem: Continued Progress And 2014 Catalysts [View article]
    If you are betting for stem cell tx, then take a look at Osiris and its procymal sales for the last several years.

    http://bit.ly/1dpNPRQ
    Dec 19 06:17 PM | Likes Like |Link to Comment
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