Lyon wrote:I'm wondering how much the talk of a phase III is just "going through the motions" and will never materialize.
As someone mentioned, they're treating large numbers of people off label, covered by health insurance, the results of which are obviously being documented.
I'm not an expert on FDA procedure but in this case, considering the hopelessness of the disease and the effectiveness of the treatment, I think that presenting the FDA with large numbers of favorable enough results, in the end is going to negate the need for a phase III.
If going through a phase III proves to be a necessary formality, it sounds like Accential has already got the wheels in motion. Unless some terrible problem exposed itself along the way, I would expect treatment to proceed as if it were FDA approved and the phase III would be nothing more than obligatory.
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