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Posted On: 05/12/2022 4:26:53 PM
Post# of 148878
“We have been more than verbally told there are no SAE's. Al the trials of every level track SAEs and show in there data there are no SAEs.”
For color, adding USS Johnston’s quote.
“Leronlimab is on clinical hold because it poses a threat to BP revenue.
If this were about safety concerns, the FDA would never have approved Remdesivir.”
The Brazil halt was us. The FDA’s halts are due to Amarex not properly aggregating safety data in the data base across several trials over multiple years. As MGK_2 has reposted, SK says in last CC that, “we believe the is solvable.” I think the timeframe was 8-12 weeks. We’re half way through.
For color, adding USS Johnston’s quote.
“Leronlimab is on clinical hold because it poses a threat to BP revenue.
If this were about safety concerns, the FDA would never have approved Remdesivir.”
The Brazil halt was us. The FDA’s halts are due to Amarex not properly aggregating safety data in the data base across several trials over multiple years. As MGK_2 has reposted, SK says in last CC that, “we believe the is solvable.” I think the timeframe was 8-12 weeks. We’re half way through.
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