First and foremost: This is not about VitroGro, this is about management.
The CEO has gone.
The Chairman has gone too.
Now there have to be, at least, two more. Number 1: the CFO, Mr. McKenzie. He let significant foreign exchange losses to happen - 1 million since 2010 (see my post http://hotcopper.com.au/posts/15066914/single). IMHO that's laziness to the power of incompetence. There is also the question of what Saskia Jo, the Corporate Accountant, was responsible for. Closing her eyes, probably. Number 2: the Regulatory and Intellectual Property Manager, Dr. Meka.
Her case is easy to make: Quote from page xi of the 2012 AR: Prior to joining TIS, she was partly responsible for the management of Tissue Therapies international patents and trademarks. One therefore can assume that she was fully familiar with the issues involved, in particular, the relevant European regulations that govern Medical Devices with Medicinal properties and the importance of a Scientific Opinion. I refer here to blip-cu's post (http://hotcopper.com.au/posts/15008275/single) that spells it out quite clearly - he refers to an EMEA document that was issued in 2007. Her failure to recognize the importance of these regulations and advise the CEO and/or board accordingly should be more than sufficient grounds for her dismissal.
However, if she did recognize the importance of these regulations and raised her concerns to the CEO, she should be dismissed because ultimately she participated in the covering up that allowed the last CR to happen.
In this context it is worthwhile to note that the company, from 2010 onwards, operated under a wrong assumption of 'IT IS ONLY NECESSARY FOR VitroGro ECM TO SUCCESSFULLY COMPLETE A DEVICE CLINICAL TEST REGIME INSTEAD OF THE PHASE TRIALS THAT APPLY TO PHARMACEUTICAL CANDIDATES'. Nobody, including the manager regulatory affairs, did notice anything wrong. Even the FDA classification as a Biologic did not wake them up. And 'THEM' also includes the European team, newly hired in 2012, with
A. Thelwell as Managing Director, EU;
Dr. . Ziegelaar as International Product Manager; and
Dr. Eva-Lisa Heinrichs, Medical Director, Glabal Medical Affairs.
In Dr. Heinrichs case one would assume that Global Regulations fall, at least to some extent, into her purview. And Europe is still part of this globe we call home.
TIS Price at posting:
10.0¢ Sentiment: Sell Disclosure: Held
