Biotech Values

[poorgradstudent]

CLDN and BTD:

According to you, FDA panel might make a mistake to grant CLDN the Breakthrough Designation Therapy without looking at the info you presented?

I doubt that the company mislead the FDA on the CUPID1 data or the FDA shortsighted on the info you mentioned.

Why?

As far as I know, the FDA looks at clinical safety and efficacy to date. Their job isn't to determine whether or not a drug is working through the method of action claimed by the sponsor. Drugs get approved even though the claimed MOA is disproven; see DNDN.

If the FDA gave them BTD for CUPID1 data, it's fine. It doesn't mean that the pivotal trial will be successful.