AI
Friday, July 11, 2008 8:23:02 PM
MNTA I'm sure you meant a "complex drug," as opposed to a small protein drug, as COPAXONE is not a protein in the context of traditional biologics.
I was mixing apples with oranges in my comment, so thank you for catching my mistake. Copaxone is a mix of polypeptides, so sort of counts as a protein, but not really...
When a CP gets filed, it becomes a matter of public record and published on an FDA website within a few days. The "citizen" is often a lawyer at a local firm, but who paid them to petition isn't public. What happens at the OGD is a black box, as rkrw pointed out.
I was mixing apples with oranges in my comment, so thank you for catching my mistake. Copaxone is a mix of polypeptides, so sort of counts as a protein, but not really...
When a CP gets filed, it becomes a matter of public record and published on an FDA website within a few days. The "citizen" is often a lawyer at a local firm, but who paid them to petition isn't public. What happens at the OGD is a black box, as rkrw pointed out.
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