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Re: None

Wednesday, 03/03/2021 10:35:15 PM

Wednesday, March 03, 2021 10:35:15 PM

Post# of 16698
Was reading through the FDA's guidance on developing covid treatments and pages 10/11 are quite interesting. it really does align with the company's position that the 15 day WHO score may not be appropriate. in fact, the document recommends measures much more aligned with AGN's secondary endpoints (mortality, ventilation, hospitalization, return to room pressure on air, etc.). It does suggest that an ordinal scale can be used but measurement should be at least 28 days out. In fact, many of the measures suggest examination at 28 days (or longer).

it seems to me that the interim analysis may not have offered a full and fair examination of the drug's potential.

https://www.fda.gov/media/137926/download