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Re: Dr Bala post# 442038

Monday, 02/07/2022 6:26:26 PM

Monday, February 07, 2022 6:26:26 PM

Post# of 820570
No, we know the FDA placed a partial clinical hold on the trial. The company should disclose the reason(s). Also, an IA was expected in '15. Again, the company should disclose if it happened (if so, what was recommended) or not. In addition, when was the 'event' threshold hit for PFS (we know it was before Feb '17), and why didn't they move forward with the process toward data lock like they said they would. I could go on and on!


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