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raf - good question. My mind has gone to the same places. Is it possible for the FDA to somehow screw with/manipulate the DMC? Anyone know?
JL - thx for the NCE clarification. The point of my post is whether there will be any follow up to insure the FDA follows Moss's decision. Or, will the FDA just continue going about it's business and change nothing (i.e., actually grant Amarin NCE)? Does anything ever really get enforced against the FDA?
go-seek, Thanks!
Speaking of the NCE case, where do things stand now? Yes, the judge, determined the FDA erred in their NCE decision, but didn't he essentially send the whole issue back to the FDA for reconsideration consistent with his findings? What now insures the FDA will act and officially grant NCE? Or, does it even matter at this point?
HDG - I don't follow your logic at all. Your statement regarding the meaning of "essential" makes no sense. Don't mean to jump in the middle of this, but I think JL is correct:)
JL - I totally agree. Amarin needs something solid from the FDA (i.e., Anchor sNDA), not just an "ok-doky, go ahead and share with docs the Anchor trial results". Gotta believe Amarin's legal team is on this same page.
HD - I think you're correct. But we gotta get more than just a promise from the FDA. FDA has none, zip, nada credibility when it comes to Amarin.
Good idea - only problem is that science doesn't matter to the FDA.
It had better be more than just "approving" communication of the Anchor data. I would not trust the FDA to not reneg on any such "approval". The FDA has never shown any intent to do the right thing where Amarin is concerned. Amarin must go for the throat while they can.
Raf - thanks, I guess the key is "consistent with his opinion". Only God knows what crap the FDA may try and pull next. They seem bent on doing anything but the right thing.
Raf - my take on a quick read of the court docs is that FDAs previous decision on NCE is vacated and essentially the whole thing is back to the FDA for reconsideration (my words). I don't see where you're getting the 5 Yr retroactive message.
Maybe it's a no-brainer based on Moss's decision? However, I don't trust anything if it's back in the hands of the corrupt, unethical agency we call the FDA.
JL - Thanks much for the info. Greatly appreciated!
BioBill/Anyone - Could someone answer Raf's question? I too have seen several posts referring to Moss offering FDA a compromise. Is that true? If so, what was the compromise? I don't have the court transcript. Just trying to get to the truth here.
I suppose if there is no pressure/incentive to get any job done, then said job could theoretically take forever to complete.
Don't know, but the longer Moss keeps dragging his backside the less positive I feel about winning. Should have been a slam dunk decision. Yea, I know, if in favor of AMRN he's gotta write an air-tight ruling. But, good grief, more than enough time to accomplish that. We're gonna get bent over like we always do
By the time Moss gets around to writing his ruling he's gonna have to call the lawyers back in to refresh his memory on what the hell he is writing about.
Yes, the NCE decision. Apparently Judge Moss is on a very extended vacation.
The guy from Forbes, like so many hacks, did not do any research on the totality of the situation. He's looking at things from a very narrow point of view.
Agree. But trust me, nowhere near the same in private sector.
Guarantee you one thing, in the end, deployment of that system will have cost 2 - 5 times what it should have cost
A little high I think. Mine is $18,393,209.99 :)
Kiwi - Thanks!
JL/Kiwi - Not sure I'm following where your numbers are coming from. From a JELIS paper I have the LDL levels in the High TG (>=150)/Low HDL (<40) subgroup were 186 +- 33 at enrollment.
They were all probably quietly shown the door to ensure the wheels of corruption keep getting greased:)
JL - Always appreciate your insights. Sure hope you're right!
gozips - Ditto your remarks!!
Kiwi - Thx again for the response. So, 20% could call a halt? Looking at the JELIS results, it would seem we could easily hit that at some point...
Kiwi - Thx for the response. You think we have a shot at stop at interim?
I hear ya. Always amazes how long some things take. Jeez, by the time Moss gets around to his ruling he'll have to call the lawyers back in to remind himself of the issues
Couldn't sleep last night so was up fantasizing over the JELIS results. I'm sure this is re-hashing old ground but, man, the results (53% reduction) in the High TG (>150), low HDL (<40) were amazing. The 957 patients in this subgroup exhibited the following risk factors at study onset:
Smokers (33%), Drinkers (35%), Diabetes (22%), Hypertension (53%), Total Chlorestol (277 +-30), LDL (186+-33), HDL (35+-4), TG (207 - 399).
Anyone know how this roughly correlates to the R-It population?
Makes a ton of difference if your hanging out on margin
When is Judge Moss gonna get off his F'ing a$$ and do his F'ing job?
Looks to me like this thing wants to head back to a buck.
Its being broadcast (on web). Just google Senate Help. I listened to Woodpecker for a few minutes. Didn't catch anything of note concerning AMRN SPA.
dead-cat - I've seen that over the years as well. But, this is Amarin where good news happens only once every other blue moon with nothing but pain and anguish the rest of the time.
Looks like we've been bent over again guys. There must be a leak somewhere on negative NCE decision by Moss. Oh well, the more things change, the more they stay the same
Biobill
Original PDUFA date was 12/20/13
SPA rescinded on 10/29/13
Pretty sure the above are correct.
Kiwi - I think you need to answer raf's question. Who do you think is paying now?
Let's hope so!!
BB - that's my comment