They have had updates and the original release did explain a process. That they went a different route could also be explained by very detailed posts analyzing the regulatory approach that they likely are following to expedite the whole process and how that also comports with certain statements they have consistently made in their financials about their regulatory approach even before they data locked.
They were to apply for FASt Track Status, and we know they have some exciting oncology and global approval programs at the FDA that require that certain hoops be gotten through before they qualify.
We also know they had a revised SAP, including a synthetic placebo arm, and they may have wished, because of these many things, to be in conversations with their regulators before they announce anything. And that makes complete sense and it also makes sense that the trial is unusual, for all of these and other complex factors make it quite an unusual and first of it’s kind trial.
Now you can choose to paint that negatively or positively. It depends what factors you include in the conversation or exclude.
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