I remember before the 2019 AGM, It was my one and only...

I remember before the 2019 AGM, It was my one and only question....tell me about TGA program....


It's been 5 years. It's not PAR's fault, I don't blame them...but this is how strict, how onerous it is. We could not have applied for mere Pain and Function despite us knowing how good the product is. We couldn't have even winged it and tried to say that our drug is SO good, so much better than std of care. That was WAY too risky.

Why?

Because it is one and done. We HAD to be much more cautious and wait for much more exemplary data. We only have one shot at this, no revisions, no second applications...no other chance. We had to be at the pinnacle of our confidence and be heavily armed with the right data.

We needed more than what's out there, by a substantial amount. We are now at that stage. We have literally climbed entire mountain ranges...we had to prove 008...we had to prove durability...we had to prove safety on top of it all.


We still have a ways to go in this specific area (TGA)...but dang it man, we are getting closer.