more clarity on if / how the COVID19 decimation of EU budgets ...affects healthcare financing

I saw the EPA arm in Mori showed LDL-C increase.

Mitra response - vital - Mori remains a serious error of finding of fact by Du

Null shows, and "Mori states in his own words" that the effects on LDL-C by DHA against control compared to EPA effects on LDL-C against control, Null Hypothesis shows NS between the two agent's effects on LDL-C.

Yes this pretty much blows the conclusion; that Mori is obvious.

anda applications to use our nda to enter the market. If our nda(Marine) no longer existed then they can't do that. Patents are gone but so is nda.

NDAs for RLDs may be withdrawn voluntarily, at the NDA holder’s request, for reasons other than safety and effectiveness. … Where an RLD has been withdrawn, ANDA products that were approved in reliance on the withdrawn RLD may continue to be marketed, and new ANDAs must refer to the withdrawn RLD as the basis for ANDA submission (provided that there has been a determination that the NDA RLD was not withdrawn for reasons of safety or effectiveness) (see § 314.122(c) (21 CFR 314.122(c))).

Now if you want to claim DHA raises LDL more than EPA, you have to do a direct comparison. When this is done, there is no statistically significant increase.

So IMO, Mori ALONE does not teach, in an obvious way that EPA raises LDL levels less than DHA. But why not?

without substantially increasing LDL-C compared to second subject having fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition and concurrent lipid altering therapy

Null shows, and "Mori states in his own words" that the effects on LDL-C by DHA against control compared to EPA effects on LDL-C against control, Null Hypothesis shows NS between the two agent's effects on LDL-C.

the baseline TG between the EPA group and the DHA group in the Mori Study were so different that one couldn't draw any conclusion when compared to the olive oil group

The NULL HYPOTHESIS "proves" that the differences between DHA's effects on LDL-C and EPA effects on LDL-C is "NS"

Mori paper states the same conclusion.

However I understand now better than I did earlier that this case depends on the judges assigned to it.

I see zero value to arm102.

have emailed IR/Covington who actually sent me a thank you message surprisingly

The issue whether the Patent Office’s examiner considered Kurabayashi or not is irrelevant and not a fatal error

the appeal hinges on Du's procedural error negating one sec. cons. against the other. As Markman pointed out--AMRN should not be punished for not qualifying for some of the other sec. cons.

we have ENOUGH sec. cons. to win appeal

They do this type of calls once a quarter. The last one was on Jan 7.

This conference call is not intended to replace the regularly scheduled call Amarin plans to hold in connection with its reporting of first quarter 2020 results. During that quarterly call management plans to respond to additional questions from analysts and investors.

So...if Amrn sued medical insurers for infringement of RI patents when using gV longer than 12 weeks for the same patient(or maybe by using some other criteria to find the infringement) it may stop insurers from making the switch to gV from V.

If I'm not mistaken, length of use for Marine is 12 weeks and this was specifically addressed at the Reno trial.

Any generic V that is refilled for the same patient after 12 weeks could be considered as infringing on Reduce it patents

I believe the 10+1 EU exclusivity starts on EMA approval not marketing

is there a way for Amarin to slow walk the EMA approval as long as possible in order to preserve the 10+1 marketing exclusivity in EU?

Roth doing an attorney call next Wednesday. I’m guessing he will be on the side of Markman and Jefferies attorney and against the Leerink attorney.

have the generic completed the entire ANDA process ?

What are your current views on AMRN's % chances of winning the appeal

If USPTO found Mori obvious which to most onboard is not for many scientifically reasons, what makes all to believe that Kura decision will be any different?

However, I wouldn’t expect Amarin to abandon all the >500 trig arguments

FDA will interpret the term court as found in section 505(j)(5)(B)(iii)(I) and 505(j)(5)(B)(iv) to mean the first court that renders a decision finding the patent at issue invalid, unenforceable, or not infringed. When it is the district court that renders such a decision, FDA may approve the ANDA as of the date the district court enters its decision.

Since an appeal has already been made to CAFC by Amarin, the FDA will not delist the challenged patents from the OB.

Are you referencing the slidedeck figure I described above.

If Generic listed figure of $500 million is not projected, but instead listed as a known for prior 12 months, is it correct to say Generics are using Amarin's last 12 months data to demonstrate their version gV has an assumed $500 mill revenue gain to their bottom line?

the Mori aspect of her ruling also

the decision is final (no appeal is possible)