Disagree. There are (or could be) options. 1) ha
Post# of 150221
(Total Views: 551)
Posted On: 10/16/2020 10:15:21 PM
Disagree.
There are (or could be) options.
1) halt and be granted EUA (not very likely)
2) continue to 390 and be granted EUA (possible)
3) be granted EUA then continue to 250 then another Interim analysis
4) halt and approve now and give leronlimab to dying placebo folks (best)
5) submit a NDA (New Drug Application) to the FDA under
pathway 505 b 1, new drug. Safety, effectiveness, and manufacturing efficiency are looked at and when metLL will be approved for marketing.
6) announcement was delayed until Tuesday to allow time for Cytodyn to negotiate something else eg partnerships or a surprise (to us)
There are (or could be) options.
1) halt and be granted EUA (not very likely)
2) continue to 390 and be granted EUA (possible)
3) be granted EUA then continue to 250 then another Interim analysis
4) halt and approve now and give leronlimab to dying placebo folks (best)
5) submit a NDA (New Drug Application) to the FDA under
pathway 505 b 1, new drug. Safety, effectiveness, and manufacturing efficiency are looked at and when metLL will be approved for marketing.
6) announcement was delayed until Tuesday to allow time for Cytodyn to negotiate something else eg partnerships or a surprise (to us)
(2)
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