Theralase Technologies Inc. V.TLT

RE:Trial data far more important than FDA

[Quattro74]

Well, sure I wouldn't mind seeing 20-25 treated in Cad. Like you say it will be less costly, then when their 1yr data comes in we can sit with the FDA for that all important AA meeting. Less chance of US shenanigans killing this trial! I say this as a yank!

newdaydawning wrote: I actually welcome the FDA hold; it allows Ph2 to develop a much larger footprint in Canada, where it is considerably less costly to play.

Let's assume we have 10 to 15 treated in as many as 6 sites in Canada before the FDA nod. That could possibly reduce the number of US sites required to reach AA.

My gut kept telling me that the FDA would block TLT's progress, and act as an never-ending headwind.

That said, I'm hardly surprised that pig-headed Americans want to sandbag something that will blow some of their homegrown competitors away.

In this business, cllnical data rules, even in the face of regulatory roadblocks.

I could care less how long the FDA wants to jerk us around.

If we bat .800 on 10 patients after 180 days, then the FDA will be left with permanent egg on its face.

And let's not forget the dozens of US sufferers who will have their bladder removes, instead of a chance at a much better quality of life.

Shameful jingoism!