Agile Therapeutics Inc (AGRX)

[Rapture2020]

Yeah but the FDA looked weak and could not even cite a hard and fast rule of the PI threshold of 5.

Plus, denying it based on a subset of the population could have enormous implications downstream.

So the FDA issues a CRL on a drug that is otherwise safer and more effective with millions of women because a subset of the population doesn’t meet the PI # (obese patients).

Apply that logic to all new drugs—that’s a brilliant way to foster innovation.