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I agree that DJL is qualified from the medical/research side, but is he assertive enough to push back, respectfully (starting with 700mg, for example instead of 350mg in trials.

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If the FDA absolutely refuses then does he tell them that then we will not be doing the trial? You have very little leverage when dealing with a federal bureaucracy that holds sole dispositive power.

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There appears to be gobs of safety data to support, are there not)?

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In widely disparate diseases the FDA will want to see the safety data by individual disease types. In cancer we have data from a small group of patients where the two trials were never finished and the study was an open-ended study. They may think that leronlimab is probably safe in cancer, but the first rule of bureaucracy is do things by the book to cover your ass.