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Message: Re: Covid PIII Questions and Thoughts

buckeyes, If memory serves me correctly, we touched upon this subject once before. 

To my knowledge, if ABL is FDA approved for COVID, as a therapeutic, a doctor can prescribe ABL for off-label use. But each other new indication following would require FDA approval. That is, each new indication will require the undertaking of a new clinical study. An NDA application, for the sale and marketing of ABL, will follow upon FDA approval for each specific indication.

 

Koo



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