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The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-1375

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    12 patients won't be enough to approve MPL for global use but it should be enough to gain the orphan drug designation.

    If companies have less than 2 quarters of funding they just need to answer a few extra questions in their quarterly report. I've held a few companies that have done this without consequence.
 
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