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Re: Lykiri post# 817633

Thursday, 03/12/2026 8:58:29 PM

Thursday, March 12, 2026 8:58:29 PM

Post# of 828438
Since you didn’t respond, I asked ChatGPT. The explanation is below. I don’t suspect any major issues—just trying to understand the process. Please let me know your opinion on why we might not fall under this category.

1️⃣ Within 28 days the company must respond
After receiving the negative or provisional opinion, the company must tell MHRA/CHM within 28 days whether it plans to:
submit written responses
request an oral hearing
or withdraw the application
If the company says “we will respond but need several months to prepare data,” that is recorded by MHRA.

2️⃣ The review clock pauses
Once the company indicates it will respond:
the regulatory clock stops
the application is paused
The company can then take several months (often up to ~6 months) to prepare its response.

3️⃣ CHM normally waits for the full response
During those months:
CHM does not usually re-review the case
it is not typically discussed again at monthly meetings
The committee generally waits until the company submits the full response package.

4️⃣ After the company submits the response
When the response arrives:
MHRA scientists review the new data
The case is scheduled for a future CHM meeting
CHM discusses the new evidence and gives updated advice to MHRA
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