Replies to post #145332 on Biotech Values

[pcrutch]

Well, Leerink is wrong. I stand by my call that the FDA notified Amarin that there was problems with the NCE status, then Amarin requested this meeting to protest.

It is NOT a good sign. You think such a rare meeting with high level FDA legal reps is a good thing one month before the PDUFA over the status of exclusivity? I think not.

I dont question whether or not it gets approved, but I do question the NCE status. I think there is only about 25% chance Amarin gets it. Previous precedents do not apply here.

[biomaven0]

“presumption in favor policy”

I believe that only applies to complex mixtures where it is unclear whether the product contains a previously approved active moiety:

Generally, if the Agency has insufficient information to know whether a product contains a previously approved active moiety, the applicant would be required to submit an NDA containing substantial clinical safety and efficacy data. These data requirements could reasonably be expected to be comparable to those that would be needed for approval of an NCE. Under the presumption, if it is not known whether a product contains a previously approved active moiety, the product also would be treated as an NCE for marketing exclusivity purposes, and, accordingly, granted 5-year exclusivity.

See discussion at:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/09/fda-applies-a-presumption-in-favor-of-nce-status-for-pancreatic-enzyme-products.html