OKAY::: we were patient though
The FDA agreed that Rett syndrome meets the criteria for a serious or life-threatening condition. However, Breakthrough Therapy will not be granted at this time because the FDA considered that data from Neuren’s exploratory Phase 2 trial provide insufficient evidence to demonstrate substantial improvement over existing therapies using conventional statistical methods.
Ann: Neuren receives response to request for Breakthrough Therapy, page-4
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$16.71 |
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| Open | High | Low | Value | Volume |
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