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Re: Nick119 post# 445236

Saturday, 02/19/2022 9:45:12 AM

Saturday, February 19, 2022 9:45:12 AM

Post# of 708873
I would hope you are right, but it would be unusual to achieve if they are in the midst of their BLA submission. They would need a very close working relationship with the RA they are submitting to first to coordinate such action. The two actions are intertwined, unless there is an avenue for them to get approval of Flaskworks independently of BLA and just focused on compassionate care, which I have never seen but their approval process has seen many new wrinkles. I would love to see such a step but I would be cautious to bet on it, just my opinion of course.

Do you have any specific info that leads you to be so confident? I would like to share your confidence level in this step.

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