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Parallels ?...hope not. ...1 for 30 reverse split
From IBD ..
RMB Gr8 data ...especially
Z. as U know ...Lupkynis targets T cells . AUPH has begun their own BAFF / APRIL program for treating LN ...just several years behind VERA
Inhibiting both BAFF and APRIL is thought to be ( based on the past several yrs of research ) , a more effective way of inhibiting B cell production which is a key factor in developing Lupus Nephritis
Event lines have clearly separated by 2 yrs ...overwhelming within 3 yrs .
Run a small trial with the same subgroup ( without the mineral oil placebo ) to confirm this data ...or at least a short trial with one cohort post MI on current SOC and a matching cohort post MI with current SOC plus Vascepa
NNT of 11 !!!!
Kiwi
RMB. Agree that Tang will be very proactive in getting a deal done . For one thing VERA is holding a KOL day on Oct 2nd where they may discuss their plans for advancing their P3 LN drug ( Baff /April combo ) which is expected to be better than AUPH's Lupkynis . So I'm sure Tang would want a deal done for AUPH before VERA's LN drug was approved . ( roughly 3 yrs out if they start their P 3 soon )
JMO
Kiwi
Well if Italy declines to reimburse for Vazkepa then it's even less likely that Germany and France will ....so there goes any meaningful EU revenues in any time frame .
In which case your plan becomes the Hail Mary throw ...way down field .
Hopefully Italy will follow Spain ...and keep that play alive ( to continue the metaphor )
Kiwi
We already have patent protection ( a solid patent moat ) in the EU until 2039
Interesting pts however
1) Even if AMRN announced today they were going to go forward with the bio equivalent in 2 cap a day form ....a year to design and get FDA approval for the trial ..possibly another year to recruit and run the trial ...then around 9 mths for the FDA to approve ...for the Marine indication only .
2) If you are already prescribed Vascepa for the R-IT indication ( as I am ) it's very unlikely an MD would want the liability of prescribing you an off label bio equivalent for the same indication. .
3) FDA won't approve the R-IT indication first on the condition that AMRN run a trial later ....This is not an unmet medical need .
If we are praying for anything ....pray of Italy to reimburse on generous terms
Kiwi
Any drug thats reformulated will need an FDA approved trial before being marketed .
The smallest trial would be a bioequivalence trial like UNCY ran on OLC which is a reformulated Fosrenol .
Even after that the FDA would probably want some kind of Outcome trial before authorizing for the reduction of cardiovascular event risk ...as opposed to simply lowering TG's
In that case ... several years and many millions of $ later .
Italy is basically make or break ....hopefully Italy will agree to reimburse
Kiwi
AUPH about to be "Tang'd "
Tang and AUPH
You shrink the size of the board to get better control to facilitate a sale ....this has Tangs MOA ( method of action ) all over it
https://www.insightia.com/tang-exits-la-jolla-in-buyout/
Kiwi
What do you make of this ? Tang is now on the BOD and wants this company sold ...thats what I make of it .
They finally got around to a BAFF/ APRIL drug ...first person dosed ....just years behind VERA who already have the same drug P3 ready .
Ernie. Raab has got ARDX from around 60c in mid 2022 to over $6 today ....he's earned his $ .
10,000 shares in mid 2022 would have cost you $6,000 .....thats now worth over $60,000 .
Be happy
Kiwi
FULC.
UGH. Trial fails
Well I do agree that if Vascepa was still patent protected in the US and owned by a BP in the cardio field ...we would see more scripts for secondary prevention R-IT profile patients
Kiwi
From poster RMB
Thx ...Yes probably no action till EOY .
I may copy and paste to the ARDX and UNCY boards
Safe travels
Kiwi
Capt Interesting study but there was also this
RMB. I listened to TLPH's presentation and my take was
1) This trial is going to take a lot longer to complete than I anticipated .
2) Even when approved their drug will be included in the dialysis bundle since its used during the actual dialysis process ...so it may be a hard sell as CMS caps each dialysis payment and dialysis co's get to keep the difference between what its costs to dialyze some one .....and what CMS pays .
I lowered my position and are now more interested in VERA, UNCY and ARDX in the CKD space .
Good luck
Kiwi
Capt. My friends main problem is uncontrolled high blood pressure
Normal range
Capt ...No that was a sincere comment . You are an expert on everything about Vascepa .
Kiwi
Thx ...you are obviously an expert on all things Vascepa .
As a side note ..do you know how many clinical trials have been run on Empaglifozin ( Jardiance ) ?
:
Well he is in his late 70's and apparently in declining health ( prior MI , High BP not well controlled , declining kidney function etc ) ...so on a risk / benefit analysis they wanted him to try Jardiance .
I know it'll come as a shock to you but unfortunately Vascepa does cure everything .
Kiwi
Capt. I think they were going off this
https://www.completecardiologycare.com/revolutionizing-heart-failure-treatment-how-jardiance-offers-hope-and-health
Kiwi
.38 c after hrs ...glad you didn't hold your breath waiting for sub .20c. :--)
Kiwi
His Cardiologist was concerned about controlling his high blood pressure better and his Nephrologist was concerned about his loss of kidney function ( eGFR ) so between them they decided Jardiance was the best add on for his most pressing risk factors .
Could he add Vascepa ?...probably , but his care team want to try Jardiance as the sole add on for a couple of mths..... to see if it improved the risk factors they were most concerned about .
Kiwi
RZLT. up 22% on the day with 4X normal vol
Kiwi
A friend ( secondary prevention now with 1 stent ) who I thought was a candidate for Vascepa ... was prescribed Jardiance instead .
His Cardiologist thought Jardiance treated a wider range of his risk factors ...which includes high blood pressure ...than Vascepa .
May be a trend
RZLT.
RMB. The LN video featuring a KOL using Lupkynis has been out for about 3 wks on the Healio Nephrology site ...a site my wife and other prescribers with CKD patients regularly visit. So I would expect an uptick in sales / scripts following this presentation.
Waiting in the wings tho are other drugs likely to enter P 3 trials and are probably more effective .
Chk this Sept 24 presentation from VERA
https://ir.veratx.com/static-files/469e722f-5da8-4dad-9a54-e52ba68596f7
VERA is currently focusing their efforts on IgAN with key data Q4 2024 ...see page 10 of their presentation re comparing to Benlysta
JMO
No position in AUPH ...altho I wouldn't sell it right now if I owned it . I'd like to see script data thru end of year
I do have a position in VERA
Kiwi