AGN's argument against the FDA's lowered requirements for bringing generic
Restasis to market is uber-compelling and, in a purely science based system; AGN should prevail.
The FDA will need to save face on this one. AGN's researchers are brilliant, and it's not the first time they have successfully challenge the FDA on process and analysis of data.
Kudos to AGN's mgmt.
I invest in lots of healthcare companies, big pharma, generics, biotechs...domestic and foreign...and I have never heard of the FDA approving a generic without human tests...(I'm guessing they have, but I don't know one)....unless there is a compelling need and some sort of disease so bad it demands quick approval....but really...this is for dry eyes....an annoying and certainly, to some, a serious disease, but hardly life threatening. Restasis is cyclosporine. Cyclosporine is no harmless drug. It is an immunosuppressant that was initially used systemically to suppress organ rejection after transplant surgery....kidneys mostly...but also heart transplants. It's a serious drug. As I've followed AGN and saw how this generic version was a threat to their franchise, I thought that the FDA had already vetted the generic versions by the same standards they apply to all other chemo-immunotherapy drugs. I guess not. I cannot believe the FDA will just shrug off AGN's complaint. Go talk to TEVA about getting generics on the market. I finally gave up on that stock after owning it for years. The generic business is nasty. Why the FDA is not doing their due diligence on this is beyond me.