I accept (not without some suspicions) the trial was done accurately. I must mention some suspicion because from no improvement in 2 weeks of screening to 25-30% improvement in first 2 weeks of trial????? Was the 2 weeks screening using the "standard care" used in the trial???
Using the car analogy of Suzuki - Rolls Royce, my question is the group in the Europe trial were they using Suzuki for 3 years prior to the trial? and was that trial using the same Suzuki care plus Vitrogro or was it upped to Rolls plus Vitro?
With the knowledge we all have now it certainly was wacko not to have a placebo control arm in that trial. Why was there no control arm?
One suspicion is that it may have been by design to ensure great results. There were very knowledgeable people involved in setting up the trial who would have known that if you used poorly treated patients and gave them gold standard then you would get a good result. Don't cloud the result by having a placebo that will show an improvement as well.
They would have known such with no placebo control arm, a trial has minimum technical validity, but retailers wouldn't know that. The figures looked amazing!! and they hadn't previously healed for 3 years, they were old and difficult patients. Pain reduction also, spectacular.
If I have a grief towards the recent management it could be that they didn't properly and expertly evaluate that Harding trial. THERE HAS TO BE A REASON WHY A GROUP WHO HADN'T HEALED FOR 3 YEARS SUDDENLY HEALED (LARGELY) AND I WOULD LIKE TO KNOW THE DETAILED TRUTH.
In summary for the real world the cohort group and treatment and screening period, may not have been a good real world example.
The setup of the European trial may have been set up to win by people that knew the variation that a standard of care may have. To use a placebo could have made it difficult. Maybe not, and if so what was the care standard prior to trial and what was standard of care during the trial.
For me this is where I got conned, coupled with my ignorance of what is meant by "standard care" which has not cropped up till the trial failure. (Just like for years the EMA rejection was because of classification till suddenly it was insufficient data.)
Also I have moved on, I don't expect any reprieve, and accept my mistakes. But there some questions and there are answers out there.
