So true about the Vegemite! It's unbelievable that they would not think, hang on... maybe it's just the standard care working.
A bit like my example before, you put some new spoilers on a Ferrari, and the Ferrari achieves a speed of 350kph, so you announce that the spoilers can make cars go at 350kph, never thinking that it might be the Ferrari that made that speed.
But no it's sound, clinical, de-risked etc etc...
"..and no, we were not told that the reason the EMA knocked VG back was because there were concerns as to its efficacy. We were told it was knocked back because the EMA considered that it was not a device and it had been entered under the wrong category."
That is so true. Before it was "... a process failure, not a product failure"
"Our belief in our ability to re‐build this Company is heavily based on our confidence in our technology and our lead product and its ability to make a difference to the lives of individuals with chronic wounds.
With out that confidence we could not proceed. That confidence is not based on a hope or a dream or a wish; it is based on solid scientific and clinical evidence and the overwhelmingly positive feed back from clinicians who have used our product. Our clinical data was insufficient to meet the EMA(CHMP) requirements for regulatory approval in Europe, not because the product didn’t perform but because the extent of the clinical data set was determined to be insufficient for a product of this nature. It was a process failure, not a product failure."
