News Focus
News Focus
Followers 43
Posts 5340
Boards Moderated 0
Alias Born 12/05/2021

Re: Lykiri post# 781000

Tuesday, 08/12/2025 5:48:55 PM

Tuesday, August 12, 2025 5:48:55 PM

Post# of 821457
than you Lykiri that MHRA reply is very interesting

The MHRA explicitly says:

"We can confirm that the Agency holds the information you are seeking."


This means yes, a medicine for the treatment of brain cancer was discussed in the May or June 2025 CHM meetings.
It’s essentially confirmation that DCVax-L (or another brain cancer drug, but let’s be realistic there aren’t many actually, there are not any) was on the CHM agenda in that period. This FOI reply is about as close as you’ll get to an indirect confirmation that DCVax-L hit CHM review in Q2 2025, without MHRA explicitly naming it yet.

Why an approval seems unlikely at end of June
If CHM had recommended approval in late June:
MHRA usually formalizes and notifies the sponsor within 1–2 weeks.
NWBO, as a public company, would be legally obligated to issue an 8-K within a couple of business days. We’re now well beyond that window ? no announcement ? no approval yet.

Two realistic scenarios left
1. CHM raised new questions ? another RFI
This aligns with NWBO’s own language about “continuing consultation with the MHRA.”
Would explain the gap between CHM review and any final decision.
Could be: SmPC/label narrowing
Manufacturing clarification (Flaskworks)
Evidence interpretation details

2. CHM did not recommend approval (outright or provisional)
A rejection would be market-moving, so NWBO would have to disclose quickly.
Since that hasn’t happened, this outcome is less likely unless NWBO is somehow arguing internally that the CHM outcome is not “final” yet.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent NWBO News