I do not want to be included because I feel many comments are at a tangent to reality. Firstly, the withdrawal of our request for a Scientific Opinion for VitroGro is prudent given that we don't yet know the nature of the studies that will be required. This will become clearer post the SAWP meeting in May. If we had continued with this request it would have been denied - and the effect of which would be worse than the more controlled wait that we are up for. The manufacturing process has been reviewed and approved. The SAWP meeting will centre on the modus operandi of the IGF-1 component of VitroGro - it provides the ancillary pharmacological action. Our trials proved we have a great solution for healing intractable wounds - that is not disputed by the EMA.
As for the effectiveness of management in the process that has taken us to where we are - I cannot complain. I know that had I been the decision maker then I would have sought the path of least resistance and it would have looked rather like the path we have taken. As for communication - there hasn't been a lot to say - we are waiting and that's tough. It's even tough for the EMA - there are 27 member states and each has separately considered our application and answers to their questions - that cannot be easy - especially with the nature of our particular device.
I have a sizable holding in this company and suspect we will get there - but am less sure now as the approval process is more complex than I ever expected. TIS is a lean machine and does not need any distractions such as this list of questions. Has anyone contacted them over the phone?
TIS Price at posting:
10.5¢ Sentiment: Hold Disclosure: Held
