In 15 years the only ODAC rulings the FDA have over-ruled have been negative ones. To overturn a postive ODAC ruling of 9-1 for the first time in 15 years, when the overwhelming evidence is there, I cannot help but conclude, in the wider context, the FDA is indeed tainted by corruption. The wrong palms were not greased.
That they would call for another ramdomized trial is absolute b/s. Any study of past decisions they have not required as much. They are literally calling for another randomized study where the placebo cohort basically die. What sort of blacked soul creatures would make such a decision over an overwhelming body of medical evidence and opinion? One can only suspect those who would put money, politics and religion (there are many who still oppose the use of stem cells in even this manner) above human lives.
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