Where went wrong?

How did we go from this (extracts from TIS ASX ann 11 Nov 2011) ......

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Clinical data from 44 difficult-to-treat venous ulcer patients treated with VitroGro® ECM for 12 weeks show:
• 34% (15 patients) were completely healed.  
•43% (19 patients) were more than 90% healed.
• 82% (36 patients) were improved ie. were        partially or completely healed.
• Average reduction in venous ulcer area was 56%.
• Average ulcer size at the start of the trial was 7.2 cm2.
• Average time the treated ulcers had not responded to expert care prior to VitroGro® ECM treatment was 36 months.
• Average age of the patients in this study was 74 years.
• Treatment twice per week was no more effective than once per week.
• No adverse events related to VitroGro® ECM have been reported after a total of more than 750 uses of the VitroGro® ECM device.
                                ........
The internationally respected wound care clinician and researcher, Professor Keith Harding from the Cardiff University Wound Healing Clinic led this study.
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...... to this ..... TOTAL ABJECT FAILURE!!!

The following is not criticism - just plain fact:

In view of the trials and tribulations of the old TIS, which as I understand it, were mainly procedural, we got together a smart and talented board. They went about setting things straight - doing it properly, dotting every i, crossing every t and leaving no stone unturned, designing the mother of all trials for a product that was obviously effective but managed shoddily. It was a no brainer. We had the added comfort of comparison with the VENUS III study as the trial progressed. It was a double no brainer.

In my shattered state, I can only come to one nonsensical conclusion ..... they picked exactly the wrong cohort, thereby demonstrating that an effective treatment is ineffective.

Last night I would have rated the possibility of this outcome as zilch as there had to be at least some degree of efficacy.

UNBELIEVABLE.