3 Batches Screw Up ?21 Jun 2018 14:08
Super weird. June 14 RNS gives Traumakine working as expected in 48 patients but not in the other 96 patients treated.
Does that mean 3 batches of drugs were used and only one batch was the right formulation/stored right ?
Or,
Mortality in the other 96 patients was exactly as expected as if on placebo at 32%. The placebo arm mortality was actually 23%.
Only way you could easily explain these figures is if they gave 1 batch of Traumakine to treated patients and 2 batches of placebo to treated patients. Placebo patients got 2 batches of Traumakine and 1 batch of placebo.
Did they use a CRO for the trial or do it themselves ? Must have used a CRO. They've never named the CRO.
Have taken modest position on this being an all time batch screw up.