(Total Views: 521)
Posted On: 10/12/2021 5:17:23 PM
Post# of 155734
If my memory serves me correctly Dr. Recknor was handing over management of the HIV BLA filing to Dr. Ray, but I still have no idea what needs to be done.
In reality we've been told the filing of the HIV BLA is just around the corner 2-3 months out for years. It would be nice to know what exactly the hold up is.
The phase 3 study hit its primary endpoint and was statistically significant, so it should seem that the clinical phase of the study is complete. What is missing and why can't we get the BLA filed?
I've heard everything from dosage justification to RO data, to improper labeling of syringes. Not sure what to believe.
In reality we've been told the filing of the HIV BLA is just around the corner 2-3 months out for years. It would be nice to know what exactly the hold up is.
The phase 3 study hit its primary endpoint and was statistically significant, so it should seem that the clinical phase of the study is complete. What is missing and why can't we get the BLA filed?
I've heard everything from dosage justification to RO data, to improper labeling of syringes. Not sure what to believe.
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