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t-
I saw HDG actually make a prediction
M-
I did not say anything about Mori. I know ... I was short, so a little bit longer
TSM & OtT.
c-
It was before "expedited" was granted. Now:
Amarin’s motion is granted to the extent that Am-arin’s opening brief is due no later than May 12, 2020, Ap-pellees’ response brief(s) are due no later than June 16, 2020, Amarin’s reply brief is due no later than June 26, 2020, and the joint appendix is due no later than July 1, 2020. The appeal will be placed on the next available oral argument calendar once briefing is complete.
f-
TSM: teaching, suggestion, motivation
OtT: Obvious to try ... Acc. to the Supreme Court, in case of no TSM, OtT could be enough
Best,
G
K-
Seems crazy to me that such as small underpowered trial with NS data such as Mori is carrying so much weight in this trial.
r-
Mori only tested each versus baseline
m-
Does your probability of a victory change much with regard to who we get on our 3 judge panel?
m-
Why do you think there is such a higher probability of the case being overturned vs. remanded back to Du's court?
m-
My guess / view:
1. less than 25%
2. less than 5%
3. more than 80-85%
Best,
G
g-
I did not read all patents' doc. But according to one of them (NOTICE OF ALLOWANCE AND FEES DUE, Application No: 13=349,153; 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27)
The prior art teaches
The prior art does not teach the administration of ethyl-EPA to patients having TG levels between 500 and 1500 mg/dl (very high) as such there is no anticipation.
However the prior art teaches that:
96% pure ethyl-EPA has been administered to patients with TG levels between 50- 499 mg/dl (borderline high/high) in order to lower TG levels in amounts that range from 1.8 per day up to 4.0 per day and for periods of time ranging from few weeks up to two years (see non-final rejection dated 04/04/2012 pages 3 through page 6). In every case substantial reduction of TG levels was observed.
The prior art also teaches that the administration of mixture of ethyl EPA and DHA (also known as Lovaza or Omacor) to patients with TG levels above 500 mg/dl (very high). The results show dramatic reduction in TG levels (about 50%).
Based on these references it was concluded that it will be obvious to treat patients having TG above 500 mg/dl with 96% pure ethyl-EPA (see pages 6-9 of the non-final rejection dated 04/04/20).
However Applicant was able to overcome the above 103 obviousness rejection by showing
1- Unexpected results and
2- Long felt unmet medical need
Both treatments lower TG significantly (50-60%) however both treatments also raised LDL-C (the bad cholesterol) significantly (about 50%). (See Lovaza package and Triplix Package see also Table on page 13 of Applicants arguments dated 09/21/2011 appl# 12/702,889)
According to Dr Weintraub there is need for treatment for patients with TG above 500 mg/dl (very high) that not only reduces the level of TG but also does not increase LDL-C which is associated
The Court is persuaded that there was a long-felt need for a drug like Vascepa ... Thus, the Asserted Claims represent an improvement — albeit a prima facie obvious one — over the prior art. And this secondary consideration therefore weighs slightly in favor of finding the Asserted Claims nonobvious.
M-
As TTE replied to you it was about TG only.
btw: The TG reduction was obvious ... the USPTO used this(!) for prima facie obviousness ... Meanwhile - If I read correctly - Judge Du referred to USPTO prima facie determination as it was about TG reduction AND LDL-C (non) effect. ...
Best,
G
N-
If we can slow down
M-
unless you're still grasping for hairs to split.
At no point did I state FDA said anything about the patents.
fact findings of the two separate federal agencies that informed or ultimately approved Amarin's patents.
M-
FDA took >500 mg/dl trigs to be a meaningfully distinct patient population for reasons relevant to V's patents.
M-
fact findings of the two separate federal agencies that informed or ultimately approved Amarin's patents
m-
There is zero, literally zero evidence that the generics would not settle. Pure speculation.
However, the lawyer noted Dr. Reddy's has shown a proclivity not to settle over the past 18 months or so. This is in line with conversations with Dr. Reddy's mgmt who has suggested they are not willing to settle.
K-
BASF has a high quality EPA production facility in the Scottish Isles ( Equatech ) that they acquired thru their purchase of Pronova I believe. They are not under contract to AMRN.
Amarins Japanese supplier ( Nisshu ? ) has noted that Amarin does not use all their existing EPA producing capacity
C- (&rosemountbomber / 277352)
Ruling expected in Q4 2020 or Q1 2021: WHAT HAPPENED TO POSSIBLY first week of September ruling???
? Evaluating whether to launch in EU directly, via a partner or in a hybrid form with decision targeted for Q3 2020: IS EUROPE BEING SLOW PLAYED TO HAVE A US COURT RULING FIRST BEFORE MAKING THIS DECISION?
EU approval they indicate Q3 2020
z-
A Vascepa generic strategy is a loser, they do not have the agreements in place like the generics to get their supply as the preferred generic. An OTC strategy is better where the generics cannot use CVD risk reduction and lose insurance coverage.
C-
Well … I am expecting lower Q2 revenue (vs Q1 / $155M) … less than $145M … 50-60% chance of less than $140M.
Due to:
- < $1M revenue from Canada (vs $6.7M in Q1)
- lower wholesaler inventory due to C19 ($7-11M effect)
Best,
G
W-
(i) they sit on Series A for 5 yrs … and "suddenly" converted most of it
(ii) the new 23,771,368 common shares are more than 5% of the total common shares … it (maybe) should trigger an "extra" 13 report … but it was not done. Maybe they sold some in April already.
Best,
G
I- (& Bluensleepy / 277208)
If Baker Bros Now Have Greater Than 10% of Shares wouldn't we know before 8/15/2020 if they sold (or bought) any additional shares?
Would this info be found in Amarin investor relations?
H- (&K-)
BB are trying to transfer into ordinary shares for liquidity of trade and then increase voting rights also?
are these now all voting shares ...all 58M ( 15% of outstanding ? )
I'm just trying to ascertain if the Baker Bros may now become more active ..especially re any sale of EU rights or EU GIA discussions .
To All (about BB's holding) &
Invest83838 / 277177
I think that your great info that they obtained 23MM+ more common shares is a great sign
If the Baker Bros now own 15% of AMRN ( up from 9.8% ? ) does that now make them an "activist " investor or do they need a representative on the BOD.
I'm using simple language here so feel free to correct ...but from memory the reporting requirements are different once a fund owns more than 10% of the outstanding shares and 13 D ? filings need to be made to report any change in ownership ...vs the quarterly 13 F
Are the voting rights for Series A and common shares both the same? or is there an advantage for either one ?
Where do you find this data
K-
I did not take it personal, just LMAO …
As per HDG's post ...whose DD I trust ...re Baker Bros
HDG has posted that they have now converted preferred ? to common and now own 15% of the common outstanding shares .
Can you confirm this ?
I-
Are You Sure it was Baker Bros who obtained these 23,771,368 common shares?
If so, do you know at what price per share it cost them?
Also, doesn't this put them back over the 10% AMRN holder designation?
B-
They have an estimated average of $3.75 no point adding.
f-
For some reason BB increased its common shares holding by 23,771,368 in April.
During April 2020, at the request of certain holders, 237,713,680 Series A Preference Shares were consolidated and redesignated, resulting in the issuance of 23,771,368 ordinary shares. As a result, a maximum of 5,160,378 ordinary shares remain issuable upon future consolidation and redesignation of the remaining Series A Preference Shares, subject to certain adjustments for dilutive events.
c-
Fda need 6 mos to review a stupid dtc ad from amrn but finished review H ANDA package in 1 mo!
M-
decision on EU would be made by Q3
we and our advisors intend to continue the dual evaluation of direct versus partner commercialization of VASCEPA in Europe with a goal of finalizing a decision by Q3 2020
our anticipated Pan European recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year.
D-
Be real.
$1 bn MC ($20 / share) is more likely … all depends on next move. (More likely dilution.)
But Tuesday - most likely - will be a fun.
Best,
G
Nope. I am busy with EVFM (and other tickers) that has an event in a near future ...
M-
I read but did not analyze … far away from make a conclusion / summary.
Best,
G
m-
the Judicial Council may very well agree with you and reject the Complaint, nothing to see here.
But if they do, it will be due to the politics of protecting one of their own, and possibly protecting Judge Du as someone they are grooming for a higher position.
By voicing your conclusions the way you did, you are directly calling into question my personal integrity and professional judgment
By reaching your unmeritorious conclusions, you are demonstrating an abject failure to understand Canon 3A(6), an abject failure to understand the Comment to Canon 3A(6), an abject failure to understand the heightened scrutiny to which a judge's comments are subjected, and an abject failure to understand the facts.
your refusal to acknowledge the applicable legal standard as applied to Judge Du's position and comment.
If you continue to pursue that line of thought, you will continue to look foolish, putting the entirety of your credibility into doubt.
let me know the next time you take real action to help Amarin shareholders beyond simply commenting on a message board
M-
Nope. Does not exist.
Best,
G
Bingo? We will see ...
M-
What "benefits of fish oil" have anything to do with V's patents trial?
Why do you have an Akita Inu?
m-
Btw, what are your credentials in this arena? Have you ever tried a case? Have you ever written a Brief? Have you ever tried to disqualify a judge? Ever taken a course on legal ethics? What exactly from abroad makes you an expert in the ethical criteria applicable to judges in the United States? Do you have a law degree? Do you have a law license?
You are certainly an expert in many things Amarin, and your Relevant Events post is go-to reading, but none of that eradicates the combined arrogance and ignorance exemplified by your haphazard comment.
M-
It is mistaken and biased
M-
How about this--those subcategories are different, some lack V's benefits or even have adverse effects missing from V.