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rosemountbomber

10/18/19 9:25 PM

#220128 RE: Hamoa #220126

Appreciate you taking the time to give us your take on this.

moonotaur

10/18/19 10:04 PM

#220132 RE: Hamoa #220126

Wouldn't any good professional do whatever they could to not provide as much information as they could in this case? I'd be a bit more concerned if AMRN willingly provided as much information as quickly as possible.

I highly doubt there is anything nefarious going on here. It is all part of the game. At this point, they just need to successfuly stall for a couple more weeks to get through the ADCOM. I imagine at that point the majority of the secret sauce of the sNDA will be in the public realm anyway.

MontanaState83

10/18/19 10:04 PM

#220133 RE: Hamoa #220126

Hamoa - complete patent dummy here (me). When is court expected to rule regarding the requested docs?

rafunrafun

10/19/19 12:09 AM

#220143 RE: Hamoa #220126

Why should and would Amarin give up that info?

Whalatane

10/19/19 12:18 AM

#220144 RE: Hamoa #220126

Hamoa. Thx for the update
Kiwi

Biobillionair

10/19/19 5:33 AM

#220154 RE: Hamoa #220126

I agree with your view on this, but don’t forget someone has influenced the delay not something....BB

Mocha Loca

10/19/19 12:05 PM

#220176 RE: Hamoa #220126

Hamoa, very interesting take. First, I'm not sure exactly why the end of discovery isn't the end of discovery. Vascepa has already had volumes of experts giving their feedback on Reduce-It. The FDA is the most important for obvious reasons, but their expertise is no greater than the combined talents of the AHA, ACC, ADA, NEJM, etc. As far as Amarin's argument about producing those communications with the FDA as being burdensome being a weak argument, how can you tell? The R-It study produced 5 million pages of data and within those data are subjects that cannot be disclosed without possibly unlocking protected patient data or sensitive discussions regarding discoveries impacting first amendment indications.