I thought this was going to be a study on all types of patients not just those with chronic ulcers. Seems only chronic patients were tested, and TIS now seems to suggest, in this document, that the market is actually chronic wounds which DO NOT respond to regular treatment . In previous discussions many posters concluded that this was for the chronic market only, but some have been doing outrageous revenue forecasts on ?total market? use.
We were told, after the winter chill, that the test would be COMPLETE end of June followed by document preparation allowance. Now we see that only 28 patients have been tested and 19 still to go and now wait until end September.
6 patients withdrawn ... lost to follow up. I wonder if any of those lost to follow up actually withdrew because Vitrogro did not work and they couldn?t be bothered. If I had clinical ulcers I would definitely make all efforts to attend if I saw that something was finally working for me!
If those 6 withdrew because Vitrogro was ineffective ... how would that change the formal result?
Has the FDA ?device? submission been approved? That was expected end of June.... or is that now also going to be September? Has a submission been made? When?
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