Replies to post #818869 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The ECA guidance should be published in final version sometime between now and first week of April. The idea is that the MHRA is supposed to give companies time to prepare before these various trial/marketing application guidelines become mandatory April 28.

Of course, once published, if mandatory is not a concern either way, a marketing decision could come sooner than April 28, which still allows parties (sponsor/regulator) to point to the then already published guideline for reasoning/backing.

[Baxers]

Yeah agreed. While the MHRA did state in their email to me in August last year that they wouldn't need the guidance to be released I do also strongly suspect that they want it published before the MA comes under public scrutiny.

If you look at the exact text of Regulation 58(1) of the HMR 2012* it states that the licensing authority must "take all reasonable steps" to ensure it makes a decision before the end of 210 days. Therefore, Clock-on limits are (unfortunately) not set in stone, whereas Clock-off limits are. In light of this, while they might (hopefully) try to get the assessment finished on or before the 210th day, they are not legally bound to and can at their discretion wait for Guidance to come out first if they so wish.

But as Flipper has pointed out the Guidance should in theory be being published very soon. I have emailed the MHRA 4 weeks ago to ask for a specific date to expect it, but so far I have not heard back yet.

*I was actually incorrect when I previously stated Schedule 11 of the HMR 2012 framework was governing the clock-on limits. Schedule 11 governs the timing for the advice and representations process instead. Regulation 58(1) governs clock-on times.