Quite possible. But I would caution against this.
Post# of 153887
(Total Views: 491)
Posted On: 06/02/2020 9:53:55 PM
Re: SouthernGold #36364
Quite possible. But I would caution against this. It gives the FDA two reasons to reject and either one would send us back to the drawing board for both because when they submit, they have to submit for a specific label.
I'd rather submit for a mild/moderate covid label and get that. Then we are off to the races. Dr's will prescribe off label for severe...if anyone gets to that stage. Then when they complete the severe trial, they can go for label expansion. But at that point, they've already got their foot in the door.
I'd rather submit for a mild/moderate covid label and get that. Then we are off to the races. Dr's will prescribe off label for severe...if anyone gets to that stage. Then when they complete the severe trial, they can go for label expansion. But at that point, they've already got their foot in the door.
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