InvestorsHub Logo

rafunrafun

08/18/15 10:45 AM

#56801 RE: Williams4076 #56800

It's not "no expired exclusivity". It's "no unexpired exclusivity for this product". So again, if AMRN doesn't currently have NME nor NCE, under what authority did the FDA tell the generics not to file aNDA's?

marzan

08/18/15 10:47 AM

#56802 RE: Williams4076 #56800

They don't have to clarify but continue 'no expired exclusivity' as long as they can take it. Like you said before Reduce It will require them to update to NCE then. This make perfect sense and I agree with you.

Sam81

08/18/15 10:49 AM

#56803 RE: Williams4076 #56800

BB,

What you mentioned is a very possible scenario, but is this the best for the company? I mean tie everything to reduce-it, and i know if unsuccessful that will be the end of the company, but even waiting for the outcome of red-it to get NCE would be bad for the company.

Lets suppose red-it failed, but we still have V approved (marine & off label by physicians) and that should be protected till 2020 with NCE & patents mostly till 2030....> V sold as trgy lowering drug which have an existing market and stream of revenue from sales. But in your scenario, the company will be gone way earlier than 2020 if red-it fail....

I dunno if the point im trying to make is clear, but just wanted to drop a quick msg whilst working

Looking forward for your insight