AI
Friday, January 21, 2005 10:45:04 AM
<<In phase 3, Macugen was tested on approximately 900 patients for two years. For Squalamine, I think the FDA will ask for 1,200 patients for two years (probably in dual trials with 600 Squalamine patients each).>>
Our expectations are very similar.
<<Your use of the word “presumably” is perfectly reasonable, by the way. It’s not an absolute given that enough patients will enroll in the main phase-2 study to get to phase 3 in a timely manner.>>
Love is blind
I think I may have mentioned on this board well before vioxx that a ceo I know, in the space, told me the fda prefers local delivery for amd. I assumed he wasn't making it up and I assumed safety was the reason. Systemic delivery is double edged for genr. Can't get much better differentiation than that. That's why the story is so appealing. But otoh safety bar is bound to be higher. How couldn't it be?
Our expectations are very similar.
<<Your use of the word “presumably” is perfectly reasonable, by the way. It’s not an absolute given that enough patients will enroll in the main phase-2 study to get to phase 3 in a timely manner.>>
Love is blind
I think I may have mentioned on this board well before vioxx that a ceo I know, in the space, told me the fda prefers local delivery for amd. I assumed he wasn't making it up and I assumed safety was the reason. Systemic delivery is double edged for genr. Can't get much better differentiation than that. That's why the story is so appealing. But otoh safety bar is bound to be higher. How couldn't it be?
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