and especially a comment to the article:
By a 6-4 vote advisors to the FDA recommended against approval of AMX0035 because the single study failed to establish its effectiveness against ALS. As one of the panelist stated:“I think it would be a disservice to the patients and their families to approve a treatment that is of uncertain benefit,” said Dr. Kenneth Fischbeck of the National Institutes of Health. “It gets in the way of developing truly effective treatments if it turns out not to be effective.”
The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-617
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