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Mad Titan

 
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  • OvaScience: Still On The Sidelines Because Of The "Minimal Manipulation" Controversy [View article]
    CTI,
    I wasn't arguing for a different endpoint. Let me say this another way to your point. There's historical birth success rates for donor egg and non-donor age in a given population. In the age >35 population, I don't think that OVAS needs to show the same level as donor egg to be considered a win because non-donor offers a key advantage over donor: all the genetic material comes from the two parents.In other words, there's going to be a level of improvement that can still be considered a win, without necessarily being numerically equivalent to donor outcomes. Separately, there's what OVAS needs to show over the control in an 80-pt study on the same endpoint of birth rate success. I've run that analysis, which I may disclose at a later date.
    Dec 23, 2013. 06:47 PM | Likes Like |Link to Comment
  • OvaScience: Still On The Sidelines Because Of The "Minimal Manipulation" Controversy [View article]
    Let me caveat a little more... The AUGMENT study would have addressed a younger population than that on average - 38-42 vs. the 45 yo you highlighted. This younger group has a higher birth success rate (21%) than the 45 year olds, which as you said have almost no shot of succeeding in a non-donor IVF (only 1%). Because the control arm in AUGMENT is this younger population, the treatment effect in an 80-patient trial randomized 1:1 will actually have to be substantial for the OVAS procedure to show statistical significance over the control. I've run the stats using common assumptions so I'm not just talking qualitatively.
    Dec 22, 2013. 11:23 PM | Likes Like |Link to Comment
  • OvaScience: Still On The Sidelines Because Of The "Minimal Manipulation" Controversy [View article]
    A good point. Agreed- this is the key clinical data, which actually would have been addressed in this age population in the AUGMENT study. Before the FDA letter come out, it would likely have been a different story for the stock to have had positive AUGMENT data in 2H13 before the regulatory question was raised. Now that the regulatory issue has come to light, OVAS has stopped enrollment in the US, so the company will not have this data in the near term for the US population. So, OVAS will have to argue the issue with the FDA without knowing the answer to that question and lacking a compelling argument that positive data could provide.
    Dec 22, 2013. 11:14 PM | Likes Like |Link to Comment
  • Gilead Nuc Forecasts At Unprecedented Levels - Where To Set Stock Expectations [View article]
    And as a reminder, the newer drugs are employing shorter post-treatment viral suppression endpoints (4 weeks post-treatment or "SVR4" vs traditional SVR24 and SVR 48) to expedite regulatory approvals. So far, I think it's a fair tradeoff to get drugs approved faster but it is possible we will see more long-term relapses in the real-world.
    Jul 30, 2013. 10:53 PM | Likes Like |Link to Comment
  • Gilead Nuc Forecasts At Unprecedented Levels - Where To Set Stock Expectations [View article]
    I hear you. You are correct that there is no cure for HIV. A theory for why THAT virus could reemerge with the withdrawal of therapy (after being undetectable in the blood for a long time on highly active anti-HIV therapy) is there could be resistant virus hiding in a body reservoir (or where the drugs don't penetrate). In the case of HCV, a similar thing could theoretically happen, but it is thought to be a curable disease. To monitor for this, the gold standard is to look for detectable virus in the blood long enough after stopping therapy. That way, if a resistant/protected virus could reemerge, this would be enough time to see it. In the case of conventional interferon-based therapies, this would be for up to 48 wks (and 96 wk+ in early studies). So, we know that conventional HCV treatments can "cure". The main issues with those treatments are that the cure rates are relatively low, especially in some variants (genotypes) of virus, and the regimens have a lot of side effects, limiting tolerability for many patients.
    Jul 30, 2013. 10:44 PM | Likes Like |Link to Comment
  • Gilead Nuc Forecasts At Unprecedented Levels - Where To Set Stock Expectations [View article]
    I usually discount at 50-150 bp over the WACC (you can find this updated on Bloomberg). I don't have my models open but it's prob in the 7.5-8.5% range for GILD. For a PE multiple PT, I consider it a 12 month PT (July 2014) so it's <0.5 period discounting to 2015 from there.
    Jul 30, 2013. 04:39 PM | Likes Like |Link to Comment
  • Gilead Nuc Forecasts At Unprecedented Levels - Where To Set Stock Expectations [View article]
    I agree- competition is important to keep in mind. I was trying to keep the article simple although I didn't always succeed. Competition is a major factor of all the revenue models for the major franchises. Thanks!
    Jul 30, 2013. 04:35 PM | Likes Like |Link to Comment
  • Vertex: Risk-Reward Less Favorable If HCV Pipeline Is In Question [View article]
    Thanks again for the feedback!
    Jul 30, 2013. 04:11 PM | Likes Like |Link to Comment
  • Gilead Nuc Forecasts At Unprecedented Levels - Where To Set Stock Expectations [View article]
    I appreciate your experience (btw, I'm also an MD by background in a healthcare fund) but with all due respect you didn't contradict any valuation arguments I made. Although you said my analysis was flawed, you went off on a clinical tangent and didn't bring it back to the numbers. I completely agree that a high cure rate with combo regimens is a positive. But we're talking about valuation here. A clinical positive is not a positive to the valuation if it is already baked in or overinterpreted... Then, you said you assume GILD earns $7 in 2015. You could turn out to be right and this turns out to be the case, but at this point, this could be an aggressive assumption, as I debated. Finally, I already said I support a long position into the launch. If we are honest with ourselves, we might agree the stock is trading on momentum and the dream of more HCV cures. However, I'd be more nervous that thesis could stumble after a launch, unless there are other legs of growth for GILD behind 7977.
    Jul 30, 2013. 03:52 PM | Likes Like |Link to Comment
  • Vertex: Risk-Reward Less Favorable If HCV Pipeline Is In Question [View article]
    I'm actually not John Tucker. But a Clark Kent who is under the radar as "Mad Titan". Thanks for reading and the helpful comments!
    Jul 29, 2013. 10:17 AM | Likes Like |Link to Comment
  • Vertex: Risk-Reward Less Favorable If HCV Pipeline Is In Question [View article]
    Agree with you, John. Prob best scenario for them at this point.
    Jul 29, 2013. 09:45 AM | Likes Like |Link to Comment
  • King Pharma: FDA Should Like Corvue - And So Will Investors [View article]
    FYI, FDA panel voted 11-5 against approval.
    Jul 28, 2009. 04:35 PM | Likes Like |Link to Comment
  • Merck / Cardiome: Big Pharma Meets Baby Biotech [View article]
    are you sure the intravenous formulation of vernakalant comes with? CRME has a deal with Astellas for the IV drug.
    Apr 10, 2009. 03:30 PM | Likes Like |Link to Comment
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