Yup. Like I said on Yahoo, its better to resolve issues like manufacturing now rather than when Lani is on the FDA's desk seeking NDA approval.
Its good to have an extra pair of eyes (well, 4 pairs of eyes - BARDA & CDC & NIH & FDA) checking the progress of Lani. That's some good guidance and robust stress testing.
Do other drug companies get this level of ongoing performance monitoring? I seriously doubt it.
Yup. Like I said on Yahoo, its better to resolve issues like...
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