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c-
M-
I do not have a c.), because he is not a knucklehead.
Best,
G
g-
g-
I know that some of you are not interested in this post … it is for the others.
(i) Meanwhile I will continue my DD regarding the US, the patent case it is not likely I will conclude / opine anything during the next several weeks / months … since it is not relevant. 99+% (100% ?) likely the US situation could be changed in Q1/Q2 2021 as the earliest …
(ii) However the Co could not sit back … wait for the "new" outcome of the US …
(iii) EU will be approved by EOY 2020. I never had a strong feeling that Day 120 will be an Opinion - since none of the chart flow show it but a timetable - but one thing is 100% sure: EU will be approved … likely before EOY 2020.
Meanwhile June 1 gone … August 31 is still possible … likely ... since I could not imagine that EMA has serious questions in the Day 120 letter … =IF they will have a second round of questions: it will be more likely something like: " You answered the this … but could you detail further …?)
(IV) As US gone (currently), the EU has to be the focus … approval by Aug 31 (known by June 25) or Nov 23 (known by Sep 17) requires a deal in the near future, since approval is one thing: agreement with the relevant body, pricing, staff on the field in EVERY country are other … and none of them is a "one-day task".
(V) The IV is true for "uncovered" region / territories also … e.g.: Middle / South America, Russia.
My thinking / view (still): This story will be "ended" in Q2 2020 one way or the other:
(a) sale of a Co + CVR for the US
(b) partnerships / licensing agreements for the RoW … and let's see what will happen with the US
Note as a hope, but as a sense … I see a.) as a realistic / valid business decision.
Best,
G
A lot of pharmacist - who had a first hand knowledge - opined … so it is B&W
Vascepa: will have a Tier 2/3/4 … what it has in a given plan … listed as TG lowering and CVE lowering drugs
generic V: will have a Tier 1/2 (preferred or non-preferred generic) … listed as TG lowering drug
- gV price will lower - unless V will go below this price - than V … independently from indication … from Tier
- ALL plan will list gV as generic alternative for V (as a drug … not as a drug for CVE reduction …)
Prescriber write a sript … patient go to the pharmacy … will get the cheaper one (to avoid any doubt: is not the cheaper one for a indication but a cheaper one between identical - as a compound not as a label - drugs)
It is plain and simple … an ESL & accountant could understand it … but it is a rocket science for some.
Without the patents: US is done. (or the Gross Margin / Net Profit will be a fraction … which means the same).
SMH ...
Best,
G
K-
m-
M-
Not yet.
Best,
G
LOL … the marketing "wizard" (JZ) is behind the patents … Just sayin ...
T-
Nowhere … furthermore I posted the proof of the opposite ( (II) Patents )
Best,
G
c-
First of all: know the difference between COGS and OPEX is not a dream …
g-
Read this . (SECONDARY CONSIDERATIONS IN NONOBVIOUSNESS ANALYSIS: THE USE OF OBJECTIVE INDICIA FOLLOWING KSR V. TELEFLEX … I do not say it gives an answer but I think it worth a read.)
c-
It is simple (for a layman like me): intergroup differences, Apo A-I differences were not statistically significant.
Best,
G
ps.: save the picture and zoom in
M-
E-
Thx.
Top of (or before …) what Kurabayashi teaches I see more important that Kurabayashi was sawn or did not by the USPTO.
I tend to see it as:
- was
- the Judge made a wrong conclusion … her factual finding is wrong … based on Kurabayashi
(Furthermore, 7 of 10 Claims are independent from Kurabayashi
as no Apo-B reference in the Claim.)
Best,
G
g-
I do not say it is impossible … but the chance of to reach / gain anything is less than the statistically significant result of STRENGHT trial …
Best,
G
J-
M-
You could find everything that I have here
Best,
G
c-
Let's see what is in the appeal … do not be surprised if it is in … (without me).
Best,
G
so what?
"before the appellants brief is done" … it was done and no Hikma on the market
If you are posting with an aim to make fun: you are successful … LMAO on every your post.
g-
J-
g-
Nope. In this case the 11th try was obvious…
Best,
G
g-
P-
Nope … it is not about validation but about … "obvious to try".
Best,
G
Really … shut up and listen. All of your post trigger a new one where you apologize your misread / misunderstand / mis-etc.
Moron ...
g-
g-
Shorty (as doggy time): Obvious result is not necessary. See the 10 study as "obvious to try" the 11th.
Best,
G
g- (&Piyao)
Something like:
a- (and all)
A thought: I found '727 patent examination only (Doc 262).
- The Judge says: "the Patent Office issued the patents-in-suit, it maintained its finding from earlier rejections that the prior art rendered all of the claims prima facie obvious."
- 3 of the 10 Claims (only) "dealing" with Apo-B
… ergo (?) the Patent Office had to overturn (7 of the 10) the initial rejection based on something other than Apo-B (most likely based on Secondary Consideration).
Anybody has access to any other documentation of PO process<
Best,
G
P-
No dispute … as science … but it is legal. (To avoid any doubt: i do not say her determination was correct or wrong.)
Best,
G
D-
Meanwhile it was not a direct reply I posted my view about the label "issue". Shortly:
c-
j-
Legal hypothesis is less rigid than scientific. e,g.: