When FDA will accept and approve BTD they may â
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Posted On: 02/11/2020 6:41:11 PM
When FDA will accept and approve BTD they may
—they may give complete approval of drug without restriction ..
—give approval to sell with confirmatory phase ( phase 4)
This really don’t change much , every doctor can prescribe this drug , company just need to follow efficacy and side effects and give updates to FDA. But it is fine , patients are treated and company makes money .,
—or continue normal trial , just approval hopefully sooner ..
My guess is that if we continue to have good results with patients , and this month 10 patients will be injected , and with approved basket trial much more ..and I too expect most patient if not all , improving , maybe not in the same degree , but improving .
I will expect some type of approval to treat patients within months ..
IMO of course ..
—they may give complete approval of drug without restriction ..
—give approval to sell with confirmatory phase ( phase 4)
This really don’t change much , every doctor can prescribe this drug , company just need to follow efficacy and side effects and give updates to FDA. But it is fine , patients are treated and company makes money .,
—or continue normal trial , just approval hopefully sooner ..
My guess is that if we continue to have good results with patients , and this month 10 patients will be injected , and with approved basket trial much more ..and I too expect most patient if not all , improving , maybe not in the same degree , but improving .
I will expect some type of approval to treat patients within months ..
IMO of course ..
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