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raistthemage

09/24/14 5:48 AM

#35218 RE: birzinho #35217

The judge can't approve the indication directly...

That is beyond the competence of a court and the court won't decide that.

What he can do is say the FDA's owes compensation for not doing so and that the FDA must abide by its SPA contract unless it can prove it has a valid reason for not doing so.

Yes, you're right, but it depends on the case. Regarding this one, surely it is unprecedented, and then you must consider that "science" and the evaluation of "scientific issue" is involved, and a judge probably won't decide on this kind of matter without experts' hearings