We probably had to withdraw the BLA completely as
Post# of 155133
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Posted On: 10/28/2022 7:41:36 PM
Re: Goosebumps #129711
We probably had to withdraw the BLA completely as part of getting the holds lifted. Maybe the FDA asked us to do it as a final step.
Truthfully, I lost hope in the BLA quite a while ago and would have been pleasantly surprised by a successful filing. I suspect Nader got shitcanned once they realized how bad it was. So let's face it, BLA has been braindead for a while, we just finally pulled the plug.
"We're gonna be an oncology company" was code for "Forget the HIV BLA."
Truthfully, I lost hope in the BLA quite a while ago and would have been pleasantly surprised by a successful filing. I suspect Nader got shitcanned once they realized how bad it was. So let's face it, BLA has been braindead for a while, we just finally pulled the plug.
"We're gonna be an oncology company" was code for "Forget the HIV BLA."
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