After so many years of company statements, we were at a point where we were supposed to hear CE Mark granted in March 2015.
It is just ridiculous the blame of each delay to EMA and it's odd procedures, together with BSI and its consultants.
The reality is that the company has been bad advised to follow a regulatory path that instead to cut the costs of the approval procedure, it has created a labyrinth of denials and in consequence a multitude of unexpected costs.
Too few patients were taken in the EU clinical sample trial, instead of a U.S. requirement where a 280 patient clinical trial is needed.
Now we are again at a stage of a un identified delay until a possible (but in reality we all know that we are in a messy situation) CE Mark approval.
There is only one positive solution at this stage.
Involve a big player that appreciate the advertised good technological platform of VitroGro. We all know that it works. A partner (a big player) that invest in Tissue its correct company value and cover and carry out for us the clinical US and EU trial costs and paperworks.
Hope that the current value (technology and test advancement) is at least USD 1 considering the 300,000,000 shares issued. Otherwise, if the value is less than that, we have been given not marketable promises.
Once we have a partner that logically will require the control of the game, we will have removed the "going concern" and the current big risk of company failure.
We have now just to learn from the others, as we have materially seen, with our losses, that errors are very costly.
We are lacking the experience to move in a complex world.
To reach a compromise with any potential buyer, the company has to clear, once for always, its patent on VitroGro. This has to be transferred to Tissue Therapies from Zee Upton on a final basis, as after such a big sum invested in Tissue Therapies from so many shareholders, it is fair and correct and transparent to know that the risk of the patent is on our hands and become a clear tradable and scalable instrument from any potential suitor and therefore is part of our destiny.
Mesoblast was able to change completely its status when a big player decided to take control of the game.
In the US is madness to be there without a big player and partner, as the regulatory framework is complicated and any potential error will cause sudden unexpected delays and costs. Moreover, especially in the US the big Pharma control the FDA game and we are a misery in size and resources. We are just today a 30,000,000 dollar company. In the US a Phase 2 level biotech company has in general a USD 200-300 millions valuation, and is visible and investable through a U.S. listing in the NASDAQ.
The U.S. investor is capable to invest in the US market, but often has difficulties to invest in the foreign markets.
Let's put our house in order.
Let's build value with the technology finally transferred in the TIS company books.
Let's share the risk together between the researchers and the shareholders.
Let's finally have some Big knowleadagble player involved with Tissue Therapies.
Let's give up our stubbornness in a path where real good lobby is needed.
Let's understand that we are in control of the approval process game.
Let's use the full possibilities of public funding where available in each country where Tissue is involved.
Let's look to be listed in the US market.
Let's have US investors taking and share the risk with us.
Let's have Tissue build and raise its company value.
Let's have some certainty in what is going on.
Let's share our knowledge with someone that understand and know how to take this product on the market.
Let's use well our last AUD 10,000,000 in the company Bank account.
Let's try not to fail.
We desrve it!
If all of the above is not possible, after transferring the technology on Tissue books, just sell all for the true price to whom is willing to buy this VitroGro technology platform, and share what is left with the shareholders.
If this is the case, stop any activity, become an empty box, reduce the costs to few thousands dollars a month and find a buyer for the patent for what is currently valued.
If the value is zero means that we have made a huge mistake, and we have just bought air.
Now we want to know our destiny.
TIS Price at posting:
12.0¢ Sentiment: Hold Disclosure: Held