Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
N7. Thank Perplexity
Kiwi
Well he got this deal done
N7.
N7. BASF IIRC brought the IPE processing facility in the Scottish Isles and may be part of an O 3 facility in France .
U might want to chk BASF " fish oil " processing facilities
Kiwi
Congrats on your accurate diagnosis .
Hope alls well in LV
Kiwi
Re TLPH ...my guess is market's concerned theres no update on trial enrollment so theres a risk Co will need to raise more $ .
Sold most of my position some time ago as noted in a previous post .
How's the weather where ever U are ?
Kiwi
Pete's works for Tang now . Tang is on the BOD and
O. thx, good article
Kiwi
Whats on the table in PBM negotiations ?
Laurent. Thx for keeping us up to date on this process.
Kiwi
N7. thx for the update
Kiwi
N7. where are we in this process in Italy ?...as a reminder ...in the EU and other parts of the world, the dates are written day / mth / yr vs in the US mth /day / yr
Kiwi
And here's a list of the double blinded placebo controlled trials run on GLP-1 drugs
Re GLP's approval for heart health in the US
From the ARDX presentation re the Kidney Patient Act that...if it pass's ... will benefit both ARDX and UNCY
Frank
@justfactstruth
$ARDX -FROM CANTOR CONFERENCE
HR 5074 and S 4510
We have 24 Sponsors / Co-Sponsors and this is truly Bi-Partisan with strong support
It has already passed the House Ways & Means Cmte and the Energy and Commerce Cmte so waiting for a floor vote.
We have many avenues for this to be settled and are hopeful to hear something by the end of the year before patients lose access to this drug
This can happen by Stand Alone HC Bill, Omnibus Bill / Mini or in the CR inclusion
Kiwi
From the ARDX presentation that relates to UNCY
North. Apologies on my quick scan . Yes Naz Co's often get longer than the initial 180 days to regain compliance ...and we are near that 180 day pt now .
Don't know of any that have been given more than a year tho.
Kiwi
.44c after hrs Ernie . Still sticking to your 30/70 chance of PPS under 20c ?
Kiwi
Thx for the detail Capt
Kiwi
Hi North ...any examples of longer than 1 yr to regain compliance ?
Slow day Ram ? Actually a very good day thx to my position in EWTX
EWTX is also in the Cardio space and aims to treat a very common heart condition ...thickening of the walls of your hearts ventricles ...a condition I found I was developing after failing an echo stress test several years ago . And no Vascepa doesnt cure it ....and neither does a low or high carbohydrate diet :--)
Anyway we await Capts UK script data which sounds encouraging .
How many months does AMRN have left to get the PPS over $1 ......at most Co's get 12 mths from the initial delisting notice
Kiwi
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