Sunday, June 01, 2025 7:56:56 PM
kabunushi,
I actually agree with you but it appears that all parties involved anticipate a flood of interest and pressure that they see no way to adequately address post approval without big problems. Other than the potential issue of patent grants and to some extent data record retrieval there doesn’t seem to be a reason all of this couldn’t have been sped up a little by NWBO and decided by MHRA at least 1 year ago with artisan if lower numbers of expected patients to be treated were being allowed to start with. The dedicated apheresis space being leased by Advent and mention of a contract for dedicated space with an existing apheresis center tell me that there was an expansion of expected demand for L which may be related to the change to cancer indication for treatment from just GBM in the NHS high priced medicines list which allows for individual funding requests from set aside funds. After this change the procurement title was added to the MIA which is a necessary component of commercial scale manufacturing. Best wishes.
I actually agree with you but it appears that all parties involved anticipate a flood of interest and pressure that they see no way to adequately address post approval without big problems. Other than the potential issue of patent grants and to some extent data record retrieval there doesn’t seem to be a reason all of this couldn’t have been sped up a little by NWBO and decided by MHRA at least 1 year ago with artisan if lower numbers of expected patients to be treated were being allowed to start with. The dedicated apheresis space being leased by Advent and mention of a contract for dedicated space with an existing apheresis center tell me that there was an expansion of expected demand for L which may be related to the change to cancer indication for treatment from just GBM in the NHS high priced medicines list which allows for individual funding requests from set aside funds. After this change the procurement title was added to the MIA which is a necessary component of commercial scale manufacturing. Best wishes.
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