Wednesday, July 16, 2025 12:50:04 PM
OK, this does not make sense. You're saying the MHRA is delaying authorization of dc-vax until eden system is approved if I read this correctly. One reason is they don't want the "headache" on having to approve it again later as a "major variation". Which I just can't believe. The MHRA, which prides itself on time of application to time of approval, is purposefully delaying approval because a small biotech company wants them to wait for a more advanced manufacturing capability?
If that were the case, wouldn't the MHRA reject the application prior to waiting 1 1/2 years , citing the reason being not enough manufacturing capability and ask NWBO to resubmit after eden was approved?
I don't believe the MHRA would delay. Its no skin off their nose approving again after major variation. Thats their job.
Production of flaskworks began in Feb 2024.
I'm sure eden works with a number of other BP agents as well as Merck.
I may be misinterpreting what was posted, as i said many times, i am not an expert, just using common sense as my guide
If that were the case, wouldn't the MHRA reject the application prior to waiting 1 1/2 years , citing the reason being not enough manufacturing capability and ask NWBO to resubmit after eden was approved?
I don't believe the MHRA would delay. Its no skin off their nose approving again after major variation. Thats their job.
Production of flaskworks began in Feb 2024.
I'm sure eden works with a number of other BP agents as well as Merck.
I may be misinterpreting what was posted, as i said many times, i am not an expert, just using common sense as my guide
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