Here’s the situation as I see it. And yes, I was one of the mugs out buying more the day before the meeting!
1) The trial was supervised by an expert in clinical trial design and wound healing and it produced excellent results across a broad spectrum of very hard to heal patients. It has been accepted as so by EMA so it’s no longer an issue
2) What remains to be done to achieve both the CE mark and supporting scientific opinion (we need both to market effectively) relates to the manufacturing process and more particularly to the long-term stability of the key protein in the VitroGro compound. It’s all about quality control and setting a use-by date for VitroGro
To my way of thinking what is required is the simulation of conditions to test the stability over a prolonged period – let’s say for argument 6 months. Now that does not mean the whole thing drags out for months as they will be able to fast track that by simulating such conditions in a laboratory. For example, they don’t test light bulbs by leaving them on for years before they can say it lasts for years- they automatically turn them on and off thousands of times a day for a couple of weeks.
TIS scientists/manufacturers can do a simulation for the test of protein stability. And TIS will get it right this time because they have the opportunity to sit down with the ‘judges’ and identify precisely what data they require to be satisfied.
Once that data is delivered and accepted we would be virtually guaranteed both scientific opinion and CE mark and it’s up and away.
Frankly, I can’t see why the whole thing should not be resolved within 6 months. So providing there are no new competitors of merit in the meantime it should be up and away for TIS with the USA as next stop.
Gee… I’m feeling better already!
TIS Price at posting:
11.5¢ Sentiment: Hold Disclosure: Held
