The fact TLT's 2000 series lasers have been recalled by Health Canada and not a word said by the company just reeks. Pretty hard not to draw a connection between that fact and the departure of the new CEO of devices division.
Yeah, you are probably right...in reading the recall by health Canada it looks like a cluster-F for delivery. They have been making that TLC-2000 for years.... has this been a problem all along or did they jump the gun .... hard to say.
I don't think this affects the Phase II study at all as a different laser is being used.
That said, it is hard to believe recruitment is so slow in Canada , while the U.S. sites have not been brought onboard yet. It is not unlike last time.... they have a very specific criteria that has to be met. I am encouraged that they at least have one candidate as of September and that Patient 6 and 5 are cancer free still.
I think they have an order to this trial... first Canadian sites.... 3 selected now.... then USA.... then Europe.
It is my guess they want to make any mistakes in this phase in Canada rather than shotgun it out immediately .... that is my guess anyway.