Well if they are waiting for Survaxm data , then collecting that data and doing statistical analysis and prepare filing will take months . Nothing will happen this year in that scenario . I hope that's not what the wait is about .
Perhaps Flipper is right and the MHRA wanted/demanded a new comparison with the Survaxm failed trial which has delayed the review process by anotther 6 to 9 months
I know of Flipper's posts, but he is far off on this.
The SurVaxM trial has not reached primary completion yet. The estimated completion date of 8/2024 is not possible as the IA did not happen until 1/2025. I would take a swag that the primary is at 180 events (typically 70-80% of patients) and the IA would then have been at 90 events (50% of the primary). So they must wait on that. I would guess next year. And then they still have to analyze and publish.
So yeah, their updating of the US trial registry is sloppy. Not exactly Earth shaking news (though if MimiVax was a public company I would expect them to inform shareholders).
There is no reason yet to assume the trial failed. It may well fail. His assertion that the investigator asserted the curves had not separated was wrong.
As an aside, I suspect the control arm in that trial will do very well. Would be interesting to how that matches to the -L treatment arm.