I owe you counterpoint to Friday’s gloomy Einhorn link. But today:
SAVE THE PLANET
Al Gore’s new book, Our Choice: How We Can Solve the Climate Crisis, launches today. Buy it here. Or the young reader hard cover edition here. Wouldn’t it be nice to keep the planet habitable for human life?
THIS IS TOTALLY COOL
Here’s a plan for the world to become entirely independent of fossil fuel (oil/gas/coal) in 20 years. We’d go 100% to wind, water and sun . . . at a cost of $100 trillion . . . which assumes no improvements in current technology (which of course there would be) and with no increases in conservation and efficiency (which there would be, also – as when I replaced the 400 incandescent watts in my kitchen with 24 LED watts that work just as well at a 94% energy reduction) . . . $5 trillion a year globally . . . lots of jobs . . . saving trillions on oil and coal each year . . . ending air pollution and reducing carbon emissions to pretty much the shavings when we sharpen pencils.
Obviously, nothing so dramatic is likely to happen. But Scientific American has done an amazing job of bringing this idea to life. Lots of cool stuff to click on, lots of important stuff to learn. Don’t miss this one.
Daniel: “I have a question about your Dendreon speculation [January, 2011, 20 puts bought for $5 each]. The study currently underway has a statistical endpoint that is based on overall survival, and everything that has been released seems to me to support that they will satisfy that part of the requirements. So, my question to you (or really your expert) is does he expect the drug to fail because the study results are going to be poor (i.e., overall survival not statistically improved), or does he expect the FDA to reject it despite the study since they still don’t show a decrease in disease progression (despite the alleged statistical survival benefit)? Personally, I think if they meet their endpoint, I don’t see how they cannot be approved given the lack of other viable alternatives and an extremely vocal patient base clamoring to try it out (if it is conceded as safe, which the FDA has already done).”
Guru says: “The rejection will come because DNDN ran an invalid study. The study they ran – the one on which they report statistical significance – does not conform to the agreement they have with the FDA (the SPA*). For recent examples of companies who were rejected for running the wrong trials in cancer, see Genzyme’s Clolar and Vion’s panel.”
* “Special Protocol Agreement. It is an agreement between the company and the FDA on the terms of the protocol. People are bullish on DNDN because in 2005, they got an amendment to the protocol for trial 9902B that was called an SPA. Fine, the protocol was amended. What the FDA did not say is that the way 9902B had been run before the amendment would satisfy the new amendment. In fact, the FDA said in 2002 in writing that a change that was virtually identical to one made in 2005 would require the start of a new trial. To satisfy the SPA as amended in 2005, Dendreon needed to start an entirely new study – 9902C. They did not start this new study. Instead, they mixed the ongoing study 9902B (which had been running since 2002) with a new study based on the amendment of 2005 and produced a final study that is not a valid satisfaction of the 2005 SPA. They should have started an entirely new study.”
So then I asked Guru: “Okay, okay . . . but does the drug WORK?! What’s your best guess as to the positive effects, if any, of the drug?”
“No,” he replied. “Unfortunately, the drug cannot possibly work.”
He could be wrong about that of course; and even if he’s right, he could be wrong that the FDA will reject it. So this is a speculation to be made – like all speculations – only with money you can truly afford to lose.
Quote of the Day
I went to St. Mary's Hall, an Episcopal girls' high school. I was one of six Jewish girls, and what I really wanted to do was to play the Virgin Mary in the school play. They wouldn't let me because I was Jewish. I wanted to say, Excuse me! Hello! She was Jewish!~actress Judith Light
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