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Posted On: 02/22/2021 3:13:45 PM
Post# of 149726
There are too many factors/possibilities/issues to consider and speculate about regarding what is going on.
1) The New Guideline for Monoclonal Antibodies released today or recently (Feb 2021) indicate the FDA is adapting to the pandemic urgency.
2) More evidence of the FDA adapting is their request for our raw s/c data when unblinded
3) They could be discussing what country gets the present inventory?
4) They could be discussing what sub-groups of s/c hospitalized patients get present vials?
5) They could be discussing financial assistance or partnering to rapidly boost production?
6) They could be discussing sub-groups where the Primary Endpoint was reached and sub-groups where the Primary Endpoint was not met, thus customizing the EUA to sub-groups.
7) They could be discussing the FDA push for the US Gov't to control distribution?
about 18 other topics that could be negotiated or debated or???
1) The New Guideline for Monoclonal Antibodies released today or recently (Feb 2021) indicate the FDA is adapting to the pandemic urgency.
2) More evidence of the FDA adapting is their request for our raw s/c data when unblinded
3) They could be discussing what country gets the present inventory?
4) They could be discussing what sub-groups of s/c hospitalized patients get present vials?
5) They could be discussing financial assistance or partnering to rapidly boost production?
6) They could be discussing sub-groups where the Primary Endpoint was reached and sub-groups where the Primary Endpoint was not met, thus customizing the EUA to sub-groups.
7) They could be discussing the FDA push for the US Gov't to control distribution?
about 18 other topics that could be negotiated or debated or???
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