Monday, July 07, 2025 10:22:21 AM
Slave1
Is flaskworks being used to make the batches for the compassionate care patients? If so, isn't that at least 5 years worth of proof it is reliable? Or could the hold up be because another system is being used? I recall a bio stock about 4 years ago was rejected by FDA because the sample the company provided for authorization was not produced by the same company/method that would be used in manufacturing. They basically outsourced the manufacturing to get their product approved quicker.
I'm just asking for opinions. Not creating FUD. Hoping for good news this week.
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