Replies to post #818498 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

On the math, I think Lyriki’s contact with MHRA a while back made a good case the Nov 28 meeting was equivalent to 143 days clock on. That’s why I think 210 (clock on) takes us into early May; however, that said, the goal is not to wait until day 210, if at all possible, both sponsor and regulator are guidance motivated to complete as soon as possible. Anyway, that’s why I believe, anytime from now through early May, MA is probable.

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

See section 2.5

[manibiotech]

Excellent post

[jtaylor042]

Nice work Baxers. Thank you

[Doc logic]

Baxers,

Could be but during all this time Advent brought increased amounts of apheresis capacity in house, Class C only expansion plans and there was a delay with GMP certification of a compatible Flaskworks unit for the clean rooms. There was a classification change from GBM to cancer on the high priced medicines list for IFR consideration too. The exceptional circumstances for clock off seem to have been for various reasons and I consider closed system manufacturing readiness a top priority for regulators. As explained in a post from yesterday, NICE will put pressure on pricing if manufacturing costs are reduced and create initial price issues for high cost medicines based on quality life years which is obviously why reimbursement at profitable levels could not happen until 10 year data and the increase in pricing made this feasible in the short term and Flaskworks made this possible in the longer term. MHRA wants this treatment approved but the cost has ALWAYS been an issue limiting access to patients. These issues now look like they are being or have been resolved finally… with a little help from exceptions which I have been expecting to be part of this process for quite some time ; ). Best wishes.

[reachjo]

Great work Bax!

[Flexroy]

Wow, that was quite thorough. I really appreciate you taking the time to create that. Looks like I still have time to add. But even if it happens anytime between now and then I'm happy with where I'm at!

[KRISGO]

Baxers, thank you!

[Baxers]

One more little thing to bolster the case for an announcement by/ before end April/ early May. Something I just noticed that had alluded me before:

In my original post I discussed mRESVIA, Moderna's mRNA therapy for Lower respiratory tract disease (LRTD), which I believe is the most similar treatment to DCVax amongst all other assessments that have followed the National Procedures pathway and which received a full MA 71 days after it's last CHM meeting.

mRESVIA however had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. What I hadn't noticed during my original review is the time it took mRESVIA to go from CHM 2 to the Approval announcement (83 + 71) is also 154 Days. The exact same length of time that it took Aucatzyl to go from it's 2nd CHM to the Announcement! I do not believe that this is a coincidence. In both cases I reckon this likely represents the maximum aggregate length of time after the 2nd CHM (Clock-On Day ~150) that the MHRA (+60 clock-on days) and Sponsor (+90 clock-off days) are allowed to respectively use (plus a stop/start buffer time allowance of ~4 days) in order to remain within the statutory clock-on limits of the HMR 2012 Schedule 11 framework - regardless of whether or not there needs to be a 3rd CHM meeting!

We know from published minutes that DCVax didn't get discussed at the January 29/30th CHM. But it could have been discussed again at the February 26/27th CHM (which would be similar to mRESVIA's 83 day gap vs a potential 91 day gap for DCVax if it was discussed - the difference in which comes entirely down to the pre-planned CHM meeting dates). Based on the MHRA publishing schedule we wont know if DCVax was discussed a 3rd time until mid to late April as it takes 6-8 weeks. Nevertheless, whether DCVax is following a 2 or 3 CHM meeting schedule, I believe that the end result (if the maximum 210 Day statutory clock-on limit is used) will still be around the same time, end April/ beginning of May.

GLTA