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seekinganswers

07/19/25 11:21 AM

#776811 RE: Slave1 #776809

Was Flaskworks used in the phase 3 trial that ended in 2018?
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barnstormer

07/19/25 12:31 PM

#776823 RE: Slave1 #776809

Slave, thanks for your response to Jesster's query. My prior question regarded whether the addition of Flaskworks to the MAA. either as part of the original submission or as a subsequent variation, was significant enough to require public notification in order to comply with SEC regulations given the potential the knowledge might have had on share price? Your response to Jesster would appear to support that it should have.
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jesster64

07/19/25 6:46 PM

#776860 RE: Slave1 #776809

"Flaskworks may have been referenced in the original submission, but before SI 2025/87, MHRA had no legal framework to approve it as part of a modular Control Site. That regulation was laid before Parliament on June 17, which gave MHRA visibility into how to structure the license, but it does not legally come into force until July 23. That matters because under existing rules, approving DCVax-L with Flaskworks before that date would not have been possible without triggering a post-approval variation."

Looks like I owe dcstock and femike an apology.
also probably thefollower and dennisdave.