Friday, February 17, 2023 8:52:30 AM
This morning EF Hutton released an update:
The “pre-BLA” meeting has not yet been scheduled. Management would like to have the manufacturing facility closer to internal validation standards before reaching out to the regulatory authorities.
Validation of the manufacturing facility located outside of Baltimore most likely will not be completed until 2H2023.
At best, they will file their BLA in Early 24!. Im laughing!
These are indisputable FACTS
Cheers!
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