“I believe we would have had FDA approval for HI
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Posted On: 12/11/2020 8:52:32 AM
“I believe we would have had FDA approval for HIV Combo 6months ago if we just submitted the application without referencing any RO Testing.”
Unlikely. RO testing is used in many drug trials. CYDY met with the FDA in regards to the combo and mono trial, many, many times over the years. The FDA likely directed CYDY to include RO data with the combo BLA during one of these meetings. No one at CYDY is experienced enough to independently decide to include RO data, so they are not to blame.
Unlikely. RO testing is used in many drug trials. CYDY met with the FDA in regards to the combo and mono trial, many, many times over the years. The FDA likely directed CYDY to include RO data with the combo BLA during one of these meetings. No one at CYDY is experienced enough to independently decide to include RO data, so they are not to blame.
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