Monday, January 12, 2026 10:25:28 AM
flipper44, you have to read the next paragraph too. These 2 paragraphs do not have anything to do with the 28-day letter.
This section is about sending the Sponsor another RFI.
But, I am going to leave it alone, and stick with my research and due diligence, the MHRA guidance, and the feedback Lykiri got directly from the MHRA.
This section is about sending the Sponsor another RFI.
But, I am going to leave it alone, and stick with my research and due diligence, the MHRA guidance, and the feedback Lykiri got directly from the MHRA.
Communication: The MHRA may informally notify the Sponsor that the CH M's advice was positive during standard assessment updates, but it does not stop the process to send a formal "advice letter" unless there are still minor outstanding issues to be addressed.
• Request for Information (RFI): If the CHM opinion is positive but minor technical or administrative points remain, the MHRA will send an RFI letter (often by Day 150) detailing these minor items for resolution before final grant.
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