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Re: flipper44 post# 425283

Friday, 12/10/2021 11:44:32 PM

Friday, December 10, 2021 11:44:32 PM

Post# of 705717
Very helpful, Dave and Flip.

Biocomparibilty studies need to registered and patients need to be consented differently than specials program. I haven’t searched, but am confident someone like Lykiri would find this information somehow. You generally do not start new studies during application as FDA may choose to wait and see. Or they can also provide you with confidence to begin. Makes me wonder about LLs little risky trial that could produce unrelated SAEs but still attributed to DCVax. To me it seems like no one is worried about process or label implications.
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