Independent

[flipper44]

Just adding a couple notes to this hypothesis.

The Survaxm trial was supposed to be enrolled
by May 2023 but was not enrolled until end of February 2024, at which time it revamped its expected primary completion date to Aug 18, 2024 thus pushing out the expected reporting date to August 18, 2025.

The DCVax-l maa submission was supposed to happen much earlier in 2023, but ultimately wasn’t submitted until late December 2023 (because of supposedly adding a new editor, vacations and whatnot 🙄), but more importantly, DCVax-L’s MAA zero clock day validation date wasn’t started until March 7, 2024. Just a couple weeks after Survaxm finished enrollment which included randomization and picking Aug 18 2024 primary completion guess, and thus August 18 2025 primary result reporting date. This made 365 days clock off plus 150 days clock on = Aug 3, 2025 and 365 days clock off plus 210 days clock on October 1, 2025. Note: 150 days clock on (+ 365 days clock off) seemed impossible to me, but now I suppose there is still a chance it could be that short.

Weird, it’s almost as if Survaxm’s enrollment completion and DCVax-L’s maa validation date sputtered and finally got traction at the same times.

The Survaxm 2b trial had unbelievable expectations for defining stat sig, some might say unrealistic, and July 16, 2025 the principle investigator was stating they are still waiting to see if curves separate out (not good for Survaxm, imo). Survaxm Primary endpoint results due August 18, 2025 midnight. This falls under my Alternative Hypothesis, wherein DCVax-l could use Survaxm 2b control arm for a more accurate NICE comparable and maybe for fda submission comparables.

Also, Draft guideline on the use of external control arms based on real-world data to support regulatory decisions, currently being edited (comments already in by July 14) for final guideline probably sometime in August? Hmm.