RE:We are still in the pre-clinical stage.Rarbar99 wrote: The FDA processing is far more rigorous and strict than it is here in Canada. In the eyes of the FDA, we are still in the pre-clinical stage. Not even stage 1.
it's important for everyone to know this.
I don't think it's that simple.
With all the data that's been collected - and all the data that is being collected - the FDA will be clear about what they still want to see.
It all depends on what ATE finds and the direction(s) they'd like to pursue.
Likely - a smaller P2 will be required before a P3 in one aspect.
But, I also see an opportunity for a P2/3 in a different aspect - should ATE chase it.
Again, still more complex than that as other avenues may persent themselves.
We need to wait for ATE findings and the path forward - then maybe we can better pin down what kind of development company we are.
Right now ... we really only know we are "on pause."