Friday, February 29, 2008 3:51:38 PM
Is that the question though?
Doesn't the FDA want data (not theory) to suggest the dossage is not more than what is needed to get the effect? Do we all not believe that the 25/50 dose is more to support the endo trial safety wise?
"why add the 50? well this is the one opportunity to really evaluate .."
Isn't that what PAHSE 2 trials are for.
Think hard here dewo. I really respect your opinion and believe that this could be a blockbuster drug in the real indications. But doesn't the anemia trial seam a little odd. Like they are really just collecting safety data points and it's not going to an NDA?
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