It sounds like this: 1. CYDY says they filed an
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Posted On: 03/18/2021 8:25:22 AM
It sounds like this:
1. CYDY says they filed an EUA with the US FDA.
a. Did US FDA tell CYDY if you file we will approve or..
b. Nader filed regardless.
2. CYDY says there is a difference between has filed and potential filings.
a. If US acceptance is “pre approved” then Brazil, Philippines etc. follows.
b. If no pre approval then Brazil, Philippines need to approve sans US FDA.
So the real question is did Nader ask the US FDA whether filing for an EUA is warranted or did he just go ahead and do it? Case 1, balloons come out of the ceiling Case 2, (IMO only) an across the board rejection. Either way I think this CC sets the course of SP for the rest of the year.
1. CYDY says they filed an EUA with the US FDA.
a. Did US FDA tell CYDY if you file we will approve or..
b. Nader filed regardless.
2. CYDY says there is a difference between has filed and potential filings.
a. If US acceptance is “pre approved” then Brazil, Philippines etc. follows.
b. If no pre approval then Brazil, Philippines need to approve sans US FDA.
So the real question is did Nader ask the US FDA whether filing for an EUA is warranted or did he just go ahead and do it? Case 1, balloons come out of the ceiling Case 2, (IMO only) an across the board rejection. Either way I think this CC sets the course of SP for the rest of the year.
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