RE:RE:- 3
Macer:
This isn't the first time TLT has fumbled the ball, this is an ongoing theme. They spend a lot of money of salaries, directors and advisors, one would think they would hire someone with the experience of getting an IND approved, knows the course to get to commercialization, etc. They had time to respond to the FDA request for more info, but couldn't within the 30 day window, that is the reason for the hold. Management is the only one we can point to that submitted an inadequate IND, the doctors, researchers, etc, all submit to Management, so they must approve everything before submitting. I am not sure of the % of trials that get put on hold are, but just a few months ago posters that we would be approved in 30 day, then no later than 60, even TLT expected to be in the US back in September. You may say we are arm chair quarterbacks, I am just asking they execute on the timelines THEY set...
G1