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Gilbert Gerber  

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  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    the documents don't include anything new as far EpiProColon is concerned, with the exception of the design of the post approval study of course.
    As a consequence my thoughts are rigorously the same as the ones developed above. EpiProColon will sail through the panel meeting.
    That said, I found the Cologuard package very informative, more informative even than the highly anticipated NEJM article. I have come to the conclusion that the DEEP-C study is a hastily done, low quality prospective study, especially considering its size. The cohort is for sure not representative of the average eligible US population and introduces a bias that overstates the true performance of the test.
    I'll post a new article post panel and pre FDA decision in order to develop this and several other arguments that will vindicate my Jan 2013 headline.
    Mar 25, 2014. 07:45 PM | Likes Like |Link to Comment
  • Exact Sciences Has Huge Potential [View article]
    you can scholar.google it as many times as you want, the PRESEPT study IS NOT the US pivotal trial. Let's get the facts straight once and for all.

    The PRESEPT study was carried out between summer 2008 and late 2009. It was financed by Epigenomics AG but overseen by an independent steering committee headed by Dr Ransohoff. And now read carefully and please remember. Each patient of the PRESEPT study was the subject of 4 blood draws and 1 colonoscopy. The 1st blood draw was used for the PRESEPT study. The other 3 samples were frozen for future use. One sample was earmarked for Abbott's pivotal trial, the second one for an additional and yet to be defined global or US licensee and the last one, of course, for Epigenomics own pivotal trial. The latter was performed in the 4Q 2011. The PRESEPT trial used the version 1 of the test as a duplicate, and the pivotal trial used the version 2 of the test as a triplicate. The pivotal trial article was submitted to a peer review journal in the summer of 2013 and awaits publication in the very short term.
    To make things a little more confusing, an additional trial had been requested by the FDA following the headline data of the pivotal trial. This is known as the head to head trial with FIT, enrolled 100 CRC cases and 200 controls, from April to November 2012. Publication of the FIT head to head trial is expected shortly as well.
    Nov 8, 2013. 08:36 PM | Likes Like |Link to Comment
  • Exact Sciences Has Huge Potential [View article]
    yes, thank you. That's what I thought: PROPAGANDA
    Nov 8, 2013. 01:42 PM | Likes Like |Link to Comment
  • Exact Sciences Has Huge Potential [View article]
    "The reality is that the blood tests are very far from real world. "

    This is the first of 3 instances you use the word "reality" in your short comment. It is also the most distant from reality of the 3, I would even call it desillusional.
    What evidence have you got to make this statement ?
    Nov 8, 2013. 05:25 AM | Likes Like |Link to Comment
  • Exact Sciences Has Huge Potential [View article]
    you correctly point out the fact that EpiProColon PMA review has been underway for a long time, precisely since February when filing was accepted and accelerated review was granted by the FDA. In yesterday's update the company stated that the FDA is diligently working on a panel date. This is very likely to happen before year-end.

    Unfortunately you incorrectly mention the PRESEPT study as the FDA pivotal study. This study was an important prospective study but it was done with the 1st generation of the test. I recommend interested readers to look up my January 16th article and my answers to some of the likewise misleading comments. In a nutshell, EpiProColon finds about 70% of cases in an asymptomatic average risk population, and the majority of early stage, curable cases. Its stated goal always has been to find cancer EARLY, not to prevent it.
    Nov 7, 2013. 05:52 PM | Likes Like |Link to Comment
  • Exact Sciences Has Huge Potential [View article]
    Not mentioning EpiProColon, the blood based CRC screening test developed by Epigenomics AG (EPGN) can only mean 2 things: 1) If it has been missed out unintentionally it is a gross mistake and makes your investment case a non starter. 2) if it has been missed out intentionally, your article is not an investment case but a propaganda tool.
    Which is it ?
    Nov 7, 2013. 05:22 PM | Likes Like |Link to Comment
  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    sorry I made a mistake, I didn't answer you directly but through a comment made by Energy Trader. Update below.
    Nov 6, 2013. 12:22 PM | Likes Like |Link to Comment
  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    3Q conf call just ended, my Jan 2013 scenario 110% on track.
    a) EUR 10m equity financing since then for about 8.5% dilution takes the cash reach to late 2014, ie 100% post FDA decision.
    b) Polymedco will take care of the sales in the US and has made an equity investment in last weeks private placement at EUR 5/share. c) BioChain has extended its March 2013 agreement and made a EUR 1m equity investment (at 4.32/share). It will take the test trough the Chinese equivalent of a PMA, ie will set up a 5000 pivotal trial and will also develop the next generation of the test with a view to reduce COGS and make it accessible to the theoretically 290m addressable Chinese population. d) FDA panel date expected to be announced any day.

    Pharmaco economic analysis published this summer and clearly supportive of the test. Pivotal and FIT head to head studies submitted to peer reviewed journals and publication expected shortly.

    The liquidity of the stock has improved significantly and about 300k shares trade daily on the 3 German exchanges, 50% of which on the Xetra market (ECX GY is the Bloomberg ticker).

    Hope it helps.
    Nov 6, 2013. 11:18 AM | Likes Like |Link to Comment
  • Billions To Be Made In Diagnostics [View article]
    good piece. One remark if I may. Your reasoning is to a large extent based on the successful track record of these industry veterans. And this is exactly why I would be cautious. Getting older they think and consequently act differently. They want to shape these companies, they want to make a statement as much as they want their investment to perform. Maybe even more. Difficult to tell.
    Sep 12, 2013. 07:08 AM | Likes Like |Link to Comment
  • Exact Sciences - Cologuard Is Strike 3, And EXAS Is Out (5 Of 5) [View article]
    character attacks are nothing more than a distraction, and proof of deep-seated unease.
    AE did disclose what was relevant: he is short. That's his motivation. Who he is is not relevant.
    Jul 30, 2013. 04:17 PM | Likes Like |Link to Comment
  • Exact Sciences - Flushing $$$ Down The Drain (2 Of 5) [View article]
    1) priced for perfection
    2) vested interest
    2 very valid points which you make calmly as a neutral observer, and which I have been trying to make as well. But people won't listen. They won't listen because they are cynical about it. Deep down they all believe that Kevin Conroy will save the day and deliver the juicy trade sale he promised from day one ("I did it once, I'll do it again, just believe me"). But Cologuard is no HPV, and my intelligence from within the industry is positive: NO WAY ANY ESTABLISHED PLAYER WOULD EVEN CONSIDER IT. NO WAY ! But how do you debunk that argument ? you can't. You can't google it away, and if not an established player, an ambitious third tier player may save the day. Or so the hope ...
    Jul 25, 2013. 05:02 PM | 1 Like Like |Link to Comment
  • Exact Sciences: Thanks For The Party, Where Is The Exit? [View article]
    I basically agree with your comment, cost will have to come down, and it will with time (ie further development) and increasing volume (economies of scale).
    What I do object in your comment in particular is the same point I address in the Jefferies survey: why is a 350 USD stool test better suited to address the unscreened market (wheras the stated positioning is to replace FIT), and the USD 150 blood test dismissed as having the potential to do that (compliance argument) And why is a USD 350 test better suited to replaced the cheap FIT than a USD 150 test (price argument) .

    I understand that not everything is clear cut about performance etc but the relative valuation does not allow room for any interpretation. EXAS is valued like a "winner takes it all" internet company, and Epigeno,ics is valued like a 100% failure.

    Logel summed up that point very nicely above. It is a very important point, which is completly ignored.
    Thanks for your input
    Jul 25, 2013. 07:01 AM | Likes Like |Link to Comment
  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    it is your second comment you do not even manage to spell my name correctly !
    As for the rest, it is not worth commenting.
    Feb 25, 2013. 05:51 AM | Likes Like |Link to Comment
  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    I am grateful to pdb100 for his answer to your previous comment. This one is for me to pick up.

    In 3 words: PRESEPT IS USELESS.

    And here is why.
    Your correctly quote the Gut article published online Feb 13th, but this is only the abstract. The abstract obviously summarises the conclusion of the trial ..... as originally designed, ie based on dupicates. The standard method for PCR though is to use a triplicate. This was ultimatelly performed, but not as part of the formal trial anymore, but as a so-called ex-post analysis. Although not official, these figures are the ones used by the company and myself in my article and previous comments.
    That is why PRESEPT is useless. Remember the trial was completed 3 years ago, the triplicate has been used ever since, and the improved version 2 of EpiProColon has been introduced for over 2 years. As a last reminder, the US pivotal data was run on version 2 and I expect a late-breaker presentation at this year's DDW in May, followed by a full publication.

    This is the link to the full article http://tinyurl.com/9wr...
    "post-hoc study of a third PCR reaction" is on page 3.
    The discussion section on page 7 goes on to say: "improvement in the test appear to be ossbile, as shown by our post hoc analysis using the three PCR replicate emulation which mimics the second generation commercially available mSEPT9 assay and which detects nearly two thirds of the cases, but yielded false positives in 12% of non-cases. The three replicate approach needs to be tested prospectively".

    for a discussion about duplicates vs triplicates, have a look at
    http://bit.ly/YvMEHd
    This time you may learn something, because listening to the Exact call the other day the only thing I learnt was that they were running one month late (and do you know why ? REPRODUCIBILITY testing. Not a good start, but is it really a surprise ?) and that Exact Sciences will be the ONLY lab of record ! No big partnership, no incentive for other labs. How do think this will translate in commercial terms ? VERY SLOW + VERY EXPENSIVE.

    Game over ? Really ? for Epi or Exact ?
    Feb 25, 2013. 05:40 AM | Likes Like |Link to Comment
  • Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
    at last some skin in the game !
    yesterday CEO Taapken flagged +20000 shares and today Chairman von Prondzynski (ex CEO Roche Diagnostics) +78000 shares from the rights issue at 1,58

    http://bit.ly/XsflpY

    That's another box ticked off on my wish list (and any potential new investor I imagine)
    Feb 1, 2013. 08:04 AM | 1 Like Like |Link to Comment
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