now that the dust has settled....

Now that the dust has settled... and I've had the time to reflect (with a few scotchs to help) I have come to the following conclusions. (and no, TDA, I don't suggest they are facts. Maybe they are just deluded hopes. You've probably had a few of those yourself in your lifetime...)

The latest announcement has gave me added confidence in the company and the product for several reasons...

1) Anyone who cares to research the legislated coverage and scope of operations and complexity of process of the BSI, the MHRA and the EMA will will soon realise that they are each bureaucratic minefields, even for the experienced, and what is expected can easily be different to what actually happens. I personally think that SM and the crowd have done their best, including accepting advice, as they have tried to negotiate the rapids.

2) I think the EMA's 210 days maximum is unlikely to occur in our case. VitroGro is a device and not a drug. The review is only on manufacturing safety and not device safety, so it is simpler to process, and the manufacturers are well known and meet all regulatory standards. Once the EMA starts their review I'd be surprised if approval took more than 3 months rather than the 7 months we have been warned about. Even if it was longer, there is almost no doubt that we will get approval, so I am relaxed about the outcomes and know that the only worry is WHEN, not IF.

3) The EMA approval will add to the immediate delays, but reduce the later delays. For example, France was expected to need additional trials and approvals. This is no longer needed as far as I can gather because EMA approval covers all member states. And many other countries accept EMA approval as well, whereas just BSI/MHRA approval was not enough. So the EMA approval may, in the longer term, reduce some costs of approval in many other jurisdictions and get VitroGro to bigger markets quicker and cheaper than would otherwise be the case.

4) The EMA is based in London down in the Docklands, which is only 10 or 12 Km away from the MHRA buildings in the Victoria district. So they mostly speak the same language and probably drink at the same pubs. Even though many of the EMA reviewers/consultants may be based in Europe, it appears to me that they may have close relationships and that may help things along.

5) I am confident that individuals and organisations that review TIS as an investment will agree with the above analysis and decide that there has been a signifcant REDUCTION of risk as a result of the announcement. It has confirmed the classification and acceptance of VitroGro and these doubts regarding legitimacy no longer exist. For any investor prepared to wait 6 months or more, TIS is a no-brainer. I am expecting the sp to hit 60c in the next month or two.

6) A capital raising is to me unlikely. If approval from EMA comes within, say 3-4 months, and sales are strong, I reckon the existing funds can stretch with some careful financial management. If we get extra European and Asian and South American countries on board due the the EMA approval, the FDA approval may not be so high priority now and so the rate of expenditure required in that direction could be slowed.

7) Overall the announcement has completely changed the dynamics. Priorities have changed in my view as we will have access to some markets earlier than planned, and the rates and direction of expenditure by TIS may need to be reviewed as a result. To some extent the way forward will depend on how quickly the EMA gives its seal of approval. I am optimistic in this regard.

It may be the scotch, but to me the way ahead is now clearer and more certain, and that is good news.

And the days of high volume sales and good profits are now in our sights, rather than beyond the horizon.

2013 will be an exciting and satisfying year for sure!