The FDA approval process for Brilacidin has been p
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(Total Views: 650)
Posted On: 08/05/2021 9:59:54 AM
The FDA approval process for Brilacidin has been painfully slow. B, with an SI of 426 is now in the "queue" for Delta testing while people needlessly suffer and die.
Yet the FDA quickly gave EUA to Big Pharm. Raises serious and justifiable questions about the approval process.
See slide 16--October 22, 2020.
https://www.fda.gov/media/143557/download
And the only EUA therapeutic approved by the FDA is Veklury (Remdesivir), earning Gilead $2.7 billion in 2020 and projected $3 billion in 2021.
From the Remdesivir Fact Sheet for parents and caregivers:
What are the important possible side effects of VEKLURY?
Possible side effects of VEKLURY are:
• Allergic reactions. Allergic reactions can happen during and after infusion with VEKLURY. Tell your healthcare
provider right away if your child gets any of the following signs and symptoms of allergic reactions: changes to
heart rate, fever, shortness of breath, wheezing, swelling of the lips, face, or throat, rash, nausea, sweating, or
shivering.
• Increases in levels of liver enzymes. Increases in liver enzymes are common in people who have received
VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your child’s
liver enzymes before receiving VEKLURY and as needed while receiving VEKLURY. Your healthcare provider
may stop treatment with VEKLURY if your child develops new or worsening liver problems.
The most common side effect of VEKLURY is nausea.
These are not all the possible side effects of VEKLURY. VEKLURY is still being studied so it is possible that all of
the risks are not known at this time.
https://www.fda.gov/media/137565/download
Yet the FDA quickly gave EUA to Big Pharm. Raises serious and justifiable questions about the approval process.
See slide 16--October 22, 2020.
https://www.fda.gov/media/143557/download
And the only EUA therapeutic approved by the FDA is Veklury (Remdesivir), earning Gilead $2.7 billion in 2020 and projected $3 billion in 2021.
From the Remdesivir Fact Sheet for parents and caregivers:
What are the important possible side effects of VEKLURY?
Possible side effects of VEKLURY are:
• Allergic reactions. Allergic reactions can happen during and after infusion with VEKLURY. Tell your healthcare
provider right away if your child gets any of the following signs and symptoms of allergic reactions: changes to
heart rate, fever, shortness of breath, wheezing, swelling of the lips, face, or throat, rash, nausea, sweating, or
shivering.
• Increases in levels of liver enzymes. Increases in liver enzymes are common in people who have received
VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your child’s
liver enzymes before receiving VEKLURY and as needed while receiving VEKLURY. Your healthcare provider
may stop treatment with VEKLURY if your child develops new or worsening liver problems.
The most common side effect of VEKLURY is nausea.
These are not all the possible side effects of VEKLURY. VEKLURY is still being studied so it is possible that all of
the risks are not known at this time.
https://www.fda.gov/media/137565/download
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