Friday, July 18, 2025 10:44:11 AM
FeMike,
You’re misrepresenting the situation (and you know it)
The argument was never about predicting a PR date. It’s about identifying the regulatory phase based on timing, process, and official statements.
The July 15 response from NICE makes the current status clear:
“NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.”
That confirms the file is open, active, and under engagement 19 months after submission. If there were deficiencies, a pause, or a reset, that would not be the language used.
NICE also states:
“The company are not yet in a position to provide their evidence submission with us and we await further contact from them.”
That sentence only makes sense if MHRA has not yet finalized the SmPC. NICE cannot review cost-effectiveness until the label exists. That is the final stage of the MAA process, and it only begins once the application is approved in principle.
You’ve read this. You understand how this works. But you’re pretending silence means nothing, when in fact it confirms that no further input is being requested. That is the definition of labeling.
Your attempt to bury the NICE quote and redirect the discussion into an artificial wager avoids what the agency actually said.
There’s nothing more to wait for procedurally. The file is closed to new evidence. NICE is on standby. The SmPC is being finalized.
No bet is needed. The sequence already explains the status.
BTW - You’re not Iron Mike in this ring. You’re Glass Joe asking for a rematch before the first bell.
You’re misrepresenting the situation (and you know it)
The argument was never about predicting a PR date. It’s about identifying the regulatory phase based on timing, process, and official statements.
The July 15 response from NICE makes the current status clear:
“NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.”
That confirms the file is open, active, and under engagement 19 months after submission. If there were deficiencies, a pause, or a reset, that would not be the language used.
NICE also states:
“The company are not yet in a position to provide their evidence submission with us and we await further contact from them.”
That sentence only makes sense if MHRA has not yet finalized the SmPC. NICE cannot review cost-effectiveness until the label exists. That is the final stage of the MAA process, and it only begins once the application is approved in principle.
You’ve read this. You understand how this works. But you’re pretending silence means nothing, when in fact it confirms that no further input is being requested. That is the definition of labeling.
Your attempt to bury the NICE quote and redirect the discussion into an artificial wager avoids what the agency actually said.
There’s nothing more to wait for procedurally. The file is closed to new evidence. NICE is on standby. The SmPC is being finalized.
No bet is needed. The sequence already explains the status.
BTW - You’re not Iron Mike in this ring. You’re Glass Joe asking for a rematch before the first bell.
Bullish
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