Published in Medical Letter on the CDC and FDA, November 23rd, 2003
The letter was issued based on the FDA's conclusion that while MT 300 achieved its primary endpoint, it failed to achieve statistical significance versus placebo for the relief at 2 hours of the secondary symptoms of migraine (nausea, sensitivity to light, and sensitivity to sound).
No clinical safety issues were identified in the letter, nor were any non-clinical issues cited as impacting the FDA's decision to issue the not approvable letter.
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