Saturday, November 22, 2025 6:29:51 PM
Great post. This discussion is so much more meaningful than arguing about success vs failure till our heads explode.
I lean towards your interpretation but I also think DD's theory answers a lot of questions too.
The main unanswered question I have is if the MHRA is still processing the original MAA 2 years after submission, why do they keep going out of the way to emphatically state that the MAA is NOT part of their backlog?
Just of the top of my head the MHRA stated this at least 3 times in writing. Once when they announced the backlog was cleared on 3/31/25, once a month later when Lyriki emailed them, and again last week in the answer to the UK parliament.
They've also implied on more that than one occasion that the application was "with the company" and we should contact the company for further information.
For a regulator consider the MAA click to be stopped for a long period of time and to state something like that there has to be something going on. I think it was probably related to a major RFI that all parties knew would take a longer time than normal.
Other possibilities include a major's revision to the MAA or the company working through major issues with the CHM. Or maybe the MHRA basically placed the MAA on hold until they cleared their backlog for some other reason? IDK
Any of these theories do explain with GZ's email to Lefty49 that the MHRA communicated infrequently with NWBO until after the announced that their backlog had been cleared ONLY 7.5 MONTHS AGO and since then have been in frequent contact.
I lean towards your interpretation but I also think DD's theory answers a lot of questions too.
The main unanswered question I have is if the MHRA is still processing the original MAA 2 years after submission, why do they keep going out of the way to emphatically state that the MAA is NOT part of their backlog?
Just of the top of my head the MHRA stated this at least 3 times in writing. Once when they announced the backlog was cleared on 3/31/25, once a month later when Lyriki emailed them, and again last week in the answer to the UK parliament.
They've also implied on more that than one occasion that the application was "with the company" and we should contact the company for further information.
For a regulator consider the MAA click to be stopped for a long period of time and to state something like that there has to be something going on. I think it was probably related to a major RFI that all parties knew would take a longer time than normal.
Other possibilities include a major's revision to the MAA or the company working through major issues with the CHM. Or maybe the MHRA basically placed the MAA on hold until they cleared their backlog for some other reason? IDK
Any of these theories do explain with GZ's email to Lefty49 that the MHRA communicated infrequently with NWBO until after the announced that their backlog had been cleared ONLY 7.5 MONTHS AGO and since then have been in frequent contact.
Bullish
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