FDA does not over-rule positive ODAC decisions, page-20

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aussieasxboss

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30/09/20

13:47

Post #: 47739722
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Originally posted by bedger: ↑

Mate I get your point, but throwing out that stat is not really helpful and we all know its non-binding, that's why I am posting the stats. Did you read the analysis I gave you, you will see they give far more useful qualitative analysis of the stats:

"We found that the FDA and ODAC reach divergent conclusions in 11.5% of decisions, with a wide range of response and risks from drugs in question. We also found that ODAC often votes strongly for or against approval. For ODAC decisions in which the FDA voted against the decision, the agreement among votes varied, but most instances show a largely unified vote against a drug (four of the seven decisions with fewer than 20% of votes in favor of the drug). Discordant decisions between the FDA and ODAC are surprising given the high degree of consensus among voting ODAC members.In conclusion, our analysis suggests the FDA often approves drugs contrary to ODAC recommendations, sometimes because additional data are provided to the FDA, but there is no indication the agency denies approval despite favorable ODAC views".

Basically FDA generally agrees with what are often very clear votes for or against by ODAC and when it hasn't in the last 13 years its only been to overturn disapproval by ODAC (which surprises the authors of the study).

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bro I'm sorry for leading everyone wrong way. me myself have parcels determining on the result tomorrow.

break it down for me - why yes ? and if you had to give a % his confident are you

and yes I know I'm not asking or your not giving me financial advice

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0 Great analysis

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FDA does not over-rule positive ODAC decisions, page-20

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FDA does not over-rule positive ODAC decisions, page-20

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