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Re: Slave1 post# 774232

Saturday, 07/05/2025 10:41:48 AM

Saturday, July 05, 2025 10:41:48 AM

Post# of 823836
Slave1,

Great job explaining all of this. Just one more important point and that is the level of subjectivity at FDA allows for greater outside influence in my opinion. This entire discussion for example can be one similar to what a review board might go through with some members claiming that without patient level data the interpretation is somehow more likely to be flawed no matter how well the data interpretation is presented and documented. This gives more room for dissent even if not actually factually based on specific circumstances. This is of very great concern for any small biotech which has no monetary influence like big pharmas do to support it through the approval process and has everything on the line. Best wishes.
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