Pipeline-in-a-drug, page-28

they already have a liquid formulation underway. If bioequvialence is the same then safety trial required. They do have a liquid formulation but it was unpalatable so hopefully just a couple of tweaks required.

they are proceeding with P2/3 H2 so proceeding for registration under ODD accelerated approval. By that stage Pharma could scoop up with liquid formulation developed.

I wonder whether FDA would have an issue with the oral tablet given ALS can cause difficulty swallowing. This is also an exclusion to the trial. However, this pathway has been ok’d by the FDA in the past.

Rilutek (oral formulation)
Tiglutik (reformulation to oral suspension)
Exservan (reformulation oral film)

This seems like a proven pathway as the current formulation can still be used unless difficulty swallowing occurs.

Not like an RC110 to RC220 scenario.