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Posted On: 08/15/2022 8:51:54 PM
Post# of 148899
To get the Clinical Hold Lifted, we need to have the Type "C" meeting with the FDA and we need to have completed the Aggregated Safety Data.
Has anyone read anything about the state of the Audit, the progress of the Audit, the capacities of the CRO for Pharmaco-Vigilance?
Has anyone learned who the CRO for Pharmaco-Vigilance is? Are they listed or discussed in the 10-K?
Has anyone read anything about the state of the Audit, the progress of the Audit, the capacities of the CRO for Pharmaco-Vigilance?
Has anyone learned who the CRO for Pharmaco-Vigilance is? Are they listed or discussed in the 10-K?
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