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This is vital. We can spend lifetimes -- each of you can spend a lifetime -- developing a bioactive drug. If you can't get them repeatedly and reproducibly and to the target area, you have wasted a career. The formula for clinical improvement in my opinion is very simple.
You have to deliver to the target and you have to have an effective drug. If you don't get the desired clinical results, you don't know which one failed. Most people here have biological training. They think it is the drug that is the problem. If most of you had physics training, you would think the delivery is the problem. We've got to know. There is more. Remember that chart of the side-by-side experiment. Take another look at that.
There’s one real outlier, I call it the “improver”, a person who improved 80 percent in his clinical score. You take that outlier out, the difference between the two sides becomes like 3 or 4 percent. So the two sides are the same except for one person. So I got very curious, what was different about that person? We don't know. We don't know because we didn't look. We find out later on that he was an early-onset patient. Is that important? Maybe he also had blue eyes. The paper does not mention this outlier, even though there's a very significant change in the outlier. Could it have been another golden nugget? I think that is troubling me. You may get the sense that I'm troubled from my less-than-usually-tolerant tone. [Laughter] Both the architecture of the Net-PD trial and this situation bother me. The first one is extremely important because it’s a rare, large, train that leaves every once in awhile, the second one because growth factors were very, very promising in preclinical experiments.
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Copyright © 2004-2009 Parkinson Pipeline Project. All rights reserved. Revised: 02/24/11. |