tis doing their best - imho

I have just had a conversation with a TIS representative and thought I would share my thoughts and opinions with you.

Firstly let me address the issue of communication as I'm sure the first question some of you will put is, "why haven't they communicated all this to the market?". My answer is that some of it has been communicated and in terms of an update now they firmly believe ASX will refuse a market release. The reason is that they have tried a number of times previously with similar sorts of announcements and ASX have refused in the past. You will either accept that or not so there's no point trying to convince you one way or the other.

Secondly, the technical issue of classification. As I suspected from my reading Vitrogro does not strictly fit under any classification Rule in Annex IX. Neither Rule 8 nor Rule 13 accurately cover its mode of action. That doesn't mean it is not a device, it simply means that when the rules were written they did not anticipate a device working the way Vitrogro works.

Thirdly, why BSI and what were the preliminary discussions? Apparently BSI have had previous experience with the approval of products similar to Vitrogro with similar modes of action where Rule 8 was used to successfully classify the devices. I am convinced that prior to engaging BSI, TIS conducted due diligence and raised all the issues we are now discussing before agreeing to engage BSI and accepting the pathway to approval using Rule 8.

Fourthly, if you are frustrated or even angry about the current state of affairs then spare a thought for those at the top. Imagine you had developed what you considered a world changing medical device. You conducted all the trials necessary to prove that the device was safe and worked beyond all expectations. You engaged a company to assess the device and classify it and approve its use. The company gave you a timeframe for this approval and not long after the timeframe elapsed they told you how good the product was and they would be approving it soon. Then shortly before you were due to receive a piece of paper and could market the product, the company says, "well, actually we're a little confused about how to classify this product so we'll have to ask for help". Then you wait, and wait, and wait. How would you feel in this position compared to how you feel now as an investor who is somewhat distanced from the product?

Fifthly, all trials of Vitrogro were conducted on the basis that it could receive the highest classification, ie Class III. Therefore what rule is used to classify it is irrelevant.

Sixthly, so what is going on now and what is TIS doing to make it right?? It has been reported on here by others that they were told by TIS that there had been no communication with BSI. My firm belief after speaking to a representative is that TIS is communicating with BSI regularly and that BSI is communcating with MHRA even more regularly. Could more be done? Perhaps BUT I think we have all had the experience where we want someone to provide us with a service which we have paid for and that person is tardy providing the service. Do we yell at the person? Do we threaten legal action? IMHO there is a fine balance between providing an incentive to get someone else to move and creating a situation where they dig their heels in and refuse to do anything. One thing that I have become aware of today is that the relationship with BSI does not end with approval. It continues over the life of the product.

Sorry for such a long post but I hope it provides some clarification for issues we have been raising.

I still have hope that approval for sale could come at any time.

Rev

Rev