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Re: HappyLibrarian post# 615958

Tuesday, 08/01/2023 7:44:01 PM

Tuesday, August 01, 2023 7:44:01 PM

Post# of 698724
The FDA prohibits any claims on safety and efficacy outside scientific presentations until the FDA has approved it on safety and efficacy. This is why Elinzano, a researcher who does not work for the company, can say breakthrough but the company cannot. Violating this law will result in DCVax being ineligible for FDA approval. Management are not going to make claims on DCVax outside scientific conferences until we have approval. We know the results are Landmark. I was hoping for an update on regulatory affairs this evening but in the end we are one day closer to that outcome.
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