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      "text": "As the data stands and as the reliability stands, you wouldn't really use the data to file with the FDA or any other reputable agencies to prove your scientific finding.",
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      "text": "Q: You're saying the data from this machine, you would not be able to use it with the FDA or any other scientific agency? A: That is correct. Q: Wow, that's pretty damning.",
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      "text": "Q: You're belief is the FDA wouldn't even really kind of accept data from this machine without validation from a traditional source? A: That is correct.",
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      "text": "As the data stands and as the reliability stands, you wouldn't really use the data to file with the FDA or any other reputable agencies to prove your scientific finding.",
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      "text": "You have to do your homework if you were to present that data because it's a lot more they put on your end when you're using a nontraditional data source like for monoclonality, for example, or cell line characterization and present it to the FDA because you're not saving any kind of money or legwork by relying just on this data. Because I know that I would have to prepare and independently submit a separate traditional assay data source.",
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      "text": "As the data stands and as the reliability stands, you wouldn't really use the data to file with the FDA or any other reputable agencies to prove your scientific finding. — Expert",
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      "text": "2F) Novartis NOVARTIS cell and gene therapy (cont’d): BLI instrument is too unreliable to be used in an FDA submission; would need to submit parallel data using traditional methods as independent verification, eliminating any time or cost savings.",
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