Wednesday, October 05, 2022 1:31:05 PM
Further correspondence with DI today:
Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.
We did not speak about the PIP engagement with the MHRA, but we did let everyone know when our protocol for 2 pediatric trials were approved (as an example)
Appreciate your inquiry.
^^
This leads me to believe they will not PR submission, but will PR acceptance of a MAA or other regulatory applications.
Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.
We did not speak about the PIP engagement with the MHRA, but we did let everyone know when our protocol for 2 pediatric trials were approved (as an example)
Appreciate your inquiry.
^^
This leads me to believe they will not PR submission, but will PR acceptance of a MAA or other regulatory applications.
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