Independent

[flipper44]

NWBO has discretion and in fact encouragement from the MHRA to share more about their MAA timing process. NWBO was more than willing to hype the potential 150 day process, but the reality is we are now potentially pushing against the extremes of timelines for innovative medicines. Let’s take a look at where we might be, since NWBO, for better or worse, continue their disrespectful and revolting silence.

This will require your attention all the way through.

Even though the guidelines below mostly went into effect after NWBO submitted their MAA, I don’t believe MHRA would be harsher than the right to extensions now in effect below regarding innovative medicines..

“The innovative medicines timetable allows for a positive decision within 150 clock-on days if all issues are resolved following one round of questions. Where there are outstanding issues at Day 150, we will come to a final decision as soon as possible and within 210 clock-on days.” Link Below

“The UK MHRA has updated its guidance on innovative medicines applications. Companies must…. follow structured timelines, including a 90-day initial assessment phase. If additional questions arise, the applicant has up to 6 months (clock off) to respond to the first request for information (RFI). A second RFI, if needed, must be answered within 3 months (clock off), and a third RFI may follow in exceptional cases. (I must assume this would give another 3 months clock off) The final decision is expected by Day 210 (clock on), unless further review is required. The MHRA also encourages submissions via the Access Consortium for streamlined international reviews.

Medicines and Healthcare products Regulatory Agency Published 3 April 2025

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines#innovative-medicines-applications

Keep reading!

Now, has MHRA delayed yet? No. So we are either operating, for clock on purposes, under 150 or 210 days. Spoiler alert, we’re under 210 day process by this point, imo, see rest of discussion.

Ok, first, technically MHRA has not delayed, if that is defined as nothing beyond 210 days delay. However, the MHRA have been tardy within that 150 day or 210 structure. How?

No matter what you hear, there is no way MHRA timely initially assessed the maa within their supposed 90 days. (I’m going to round off all months to 30 days for convenience)

Initial assessment was supposed to begin March 6, 2024.

90 days from that is approximately June 6.

Guess what? The initial assessment wasn’t completed then. No official delay but the MHRA were already eating up clock on time during their initial assessment

MHRA weren’t even done by June 30. Tardy tardy tardy, but not officially late.

I think this ends up taking the MHRA out of any chance of completing within 150 days clock on when the process is done.

In fact, it looks like this is exactly where they essentially lost nearly 60 days, because it appears from all NWBO signs before they clammed up, MHRA burned up about 150 days on their initial assessment, finally getting the RFI request to NWBO around August 1.

So great, now we can explain why we aren’t in the 150 day program anymore, the MHRA burned them up early. Instead of 90 days they took around 150 for the first response.

Remember what the MHRA says about this above.

Where there are outstanding issues at Day 150, we will come to a final decision as soon as possible and within 210 clock-on days.

OK, no sweat, they still have 60 days clock on for their purposes.

Now, assuming NWBO received the RFI on or about August 1, 2024, everyone and God knows they’d take the full six months now allowed for the first response.

Yep, that takes us all the way to February 1, 2025 under the new regs above.

Welp, clock turns back on for MHRA, and damn if they don’t have only 60 days left before they would be considered delayed.

We must assume the MHRA took 30 days and pumped out a second RFI. Yep, that takes us to March 1, 2025.

Yep, that takes us to about 180 days clock on. (Actually probably only 174 and that becomes important) Believe it or not, this is not strange yet.

We then must assume NWBO took the full 90 days to respond.

Yep, that takes us to about June 1.

Had things gone normally from here, we’d have our answer by around July 1 or maybe July 7.

We didn’t. So we must assume MHRA efficiently used maybe half of their remaining 36 days to pump out an unusual but allowed third RFI.

Now MHRA would be at something like 195 of 210 days clock on.

That takes us to about June 17.

Guess what? NWBO would get 90 more days to respond.

Yep, that takes us to about September 17.

MHRA, normally has 30 days left of their 210 days to make their final decision.

However, here, we must assume they only have about two weeks.

Yep, that takes us to about October 1. (••Possibly as early as September 1)

Could I be long by one month? Of course.

(** It could be the RFI came on July 1 2024 not August 1.)

Assuming all this to be true, we are here because MHRA burned up lots of their days early (taking themselves out of their own 150 day quickie), and NWBO used every second of time to answer three separate RFIs.

Could everyone squeeze this into the 150 day clock on? No way in hell.

Could we still be “on time” under the 3 RFI atypical but guided for 210 day clock on above?

Yes, it’s still very possible everything is on time, but, if that’s the case, why this can’t be explained to the public by either side MHRA/NWBO is 100% revolting and disrespectful imho.