Replies to post #203 on Independent

[flipper44]

(BTW, when going through my last post’s timeline, factor in MimiVax might release if they met their primary endpoint by August 18, 2025. I personally do not guess MimiVax met it. August 18 would be before NWBO would hypothetically need to have completed a response to a potential third RFI.)

[flipper44]

Just for the alternative under my related post above, I thought I should just briefly consider a little more accurately the what if, if first rfi received on July 1 instead of August 1, 2024. So unlike my related post above rough estimate for this scenario, regardless if the first RFI came in by July 1 or Aug 1 2024, we are now likely looking at first week of October for decision. That is, if MHRA keeps it at or slightly under 210 days (clock on) and if NWBO uses the max response times everytime. Just my opinion. (If I’m freakishly wrong about the time it takes MHRA to assess 2nd and third responses, the extreme minimum time could be as short as early to mid August)

This is, in my opinion, the most extreme length things can go without official delay by MHRA or
things going into an appeal which I do not foresee at all, but can happen in theory.

1. MHRA initial assessment only burned up 114 days of clock on, as opposed to 144.

2. NWBO assumed to use all 6 months (clock off) to about January 1.

3. MHRA assumed to burn 30 more days (clock on) and hand out second rfi, taking thing to about February 1. Now up to cumulative 144 days clock on.

4. NWBO assumed to burn 90 days (clock off)
Taking things to About May 1, 2025.

5. MHRA assumed to burn 30 more days (clock on) and hand out third rfi taking things to June 1. 174 cumulative clock on.

6. NWBO assumed to burn final 90 days (clock off) getting response in by September 1.

7. MHRA make final decision first week of October.

[flipper44]

I’m replying to the above linked post, because in that post I stated there was “no way in hell” MHRA “clock on” could come in at or under 150 days considering MHRA’s slow initial analysis.

I want to take that back.

Consequently, under the MHRA general guidelines, the extreme latest that I can see a decision occurring on the DCVax-l maa, after what I guess have been 3 RFIs, is approximately Aug 3 (aka 150 days clock on + 365 days clock off ) to as late as October 1 (aka 210 days clock on + 365 days clock off) give or take a few days to announce. (that is unless MHRA falls into official delay beyond October 1, or an appeal is necessary, neither of which I expect but are theoretically possible).

Why am I now relaxing my position on the 150 day option? Well, the short answer is because we received knowledge from the public MimiVax interview that Survaxm curves did not separate out yet on July 16, 2025 (note: not good for Survaxm chances, because they should have separated out already, imo). This is likely the earliest NWBO thought Survaxm news might arrive, JMHO. (The scheduled official report date was and still is a month later on Aug 18, 2025)

That puts August 3 at a little more than two weeks following the Survaxm July 16 heads up. Remember, MimiVax is a private company with no SEC rules to follow. Anyway, I hypothesize that at least as far back as March 7, 2024, NWBO was preparing for a window correlating/tracking DCVax-l MAA (150 or 210) + (365 days clock off) day clock on process with the Survaxm trial that was fully randomized a couple weeks earlier on February 23, 2024. Under my alternative hypothesis, they were always ready to follow within a couple weeks (see my recent posts on two weeks). JMHO. Not trying to get hopes up, I just don’t want to leave something out.

Note: It was only during DCVax-l’s maa review that MHRA were motivated to expand allowable MAA clock off response times for innovative technologies to a potential cumulative 365 days.