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Table saws ..oiy .....best to avoid . 2 friends have lost part of a finger each , using table saws
UNCY, TLPH and VERA are my current CKD / dialysis positions .
I just sold my SWAV ...the core position I'd kept since $40
Re UNCY. since this trial is open label , if stock goes south badly before results I'll probably bail ...at least most of position
Good luck
Kiwi
Thx Dew I've held a core position from around $40 to today's $325 ...bumpy ride at times.
Another win for SF / Bay Area biotech :--)
Kiwi
Marjac. re
Ex Agree. The buyback is a dumb idea. Co needs to spend the $ on increasing the level of evidence ( currently 2 b ) to get wider reimbursement in the EU .
With the patent extension they now have time to do that .
Hope they do
Kiwi
Their pivotal trial is fully enrolled and over half have probably completed the trial by now .
This trial is Open Labeled ...they know who is on the drug ..so can see how they are doing
RMB. sorry been doing some minor retrofitting in the house ...remind me to never do that again ..always costs more and takes longer then I planned for ..---)
Re TLPH .....This Co is very unlikely to sell this product . They will sell to a large Pharma in the Renal space.
This is a specialty drug / treatment simply trying to get FDA approval on a drug used for decades in Japan and Korea .
It's a niche drug that ICU MD's needing to dialyze patients ...especially those with trauma or bleeding risk.
Keep an eye on UNCY
Their pivotal trial is fully enrolled . Most have probably already completed .
Its Open Label ...so they know how the patients are doing re tolerability
I agree. With the 8 yr extension of patent protection in the EU it's worth a spec buy at these levels.
Now the Co has extra time to independently confirm ( raise the level of evidence rating ) at least for some of the R-IT results and get wider reimbursement in the EU
JMO
Kiwi
AMRN
ANNX. P3 data in Q2 ...anyone following this Co ?
Kiwi
Its random risk off in a down market . This Co will live or die on a successful trial before their money runs out.
JMO
Kiwi
Well my ploy was to get you to verify it .
So obviously I've failed in that endeavor :--)
Kiwi
Hi RMB. Well it's a ..".only risk what you can afford to lose " type situation .
OLC is the strongest phosphorous lowering drug for dialysis patients with the important convenience of being one small pill swallowed with meals.
The challenge will be tolerability .
How many report stomach upsets etc and if they are bad enough to stop taking OLC.
The Co has learnt from earlier trials and will start with a low dose , gradually increasing dose just enough to lower serum phosphorus to the desired zone .
The funds Nantahala and Vivo have some serious $ at risk here so I'm assuming they have done very extensive DD .
Something else for you to consider ...TLPH ...starting a short pivotal trial .
Chk with me on that board if interested .
Nantahala is a major investor with a seat on the BOD
Kiwi
How do you know if Chat GPT didn't summarize the key pts accurately ...unless you actually looked up the FDA doc. ?
You can't .
The value of this board , to me at least , is that generally posters will back up their pts of view with links supporting their opinion.
Kiwi
So how about getting the correct answer ...copy and pasting it for us so we can see how accurate ChatGPT was ...and the time it took you to find the answer.
I'm not saying ChatGPT is perfect ...its obviously a work in process ...and I'm biased as NVDA has been my 1/3rd largest position for the past 10 mths
Kiwi
Well the question was ...Market exclusivity following approval .
Where is that mentioned in your links ( copy and paste section ...thx ) and how much time did you spend finding it ?
Kiwi
Some more :---)
ChatGPT's answer
Yes ...Breakthrough designation if approved grants market exclusivity for ??? years ?
Kiwi
Dew. a more specific answer to your questions re TLPH
TLPH. Hi Dew ...understand that this is a layman's read . My wife who rounds dialysis clinics is loath to discuss her work / patients unless she initiates the conversation / vent.
The issue is primarily in the ICU dialysis setting . Heparin and Citrate have relatively long half lives and recirculate from the dialysis lines back into the patient . These patients in the ICU often have bleeding issues and may be intolerant to Heparin and Citrate.
Nafamostat has a very short half life so far less of it gets recirculated back into the patient. .
In non ICU dialysis its use may be for those intolerant to heparin and citrate .
My quick layman take
Believe its FDA designated as Breakthough and they agreed to device track for approval based on extensive history in Korea and Japan
Kiwi
Steve I just wanted to forward this on to you if another angiogram or procedure is being considered .
Don't know what your eGFR ( kidney function ) is but this is the latest on reducing kidney injury from the contrast typically used in angiograms .
Maybe forward to your interventionist if appropriate
https://www.practiceupdate.com/c/163795/1/2/?elsca1=emc_enews_expert-insight&elsca2=email&elsca3=practiceupdate_cardio&elsca4=cardiology&elsca5=newsletter&rid=NDE0ODg4MzcyNTk0S0&lid=20845029
Good luck
Kiwi
TLPH. Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
RZLT. DME P2 results in Q2
https://www.rezolutebio.com/for-patients/living-with-dme/
Kiwi
Ps. I've been selling some on the way up so I don't do a face plant on this if P2 fails
DME P2 results due Q2
https://www.rezolutebio.com/for-patients/living-with-dme/
Kiwi
Hi Steve. I'm spending more time on RZLT now ( been in it for awhile )
So come over to that board if you're interested..
I've had a core position in SWAV since soon after its IPO ...trading around it .
I'll keep that position until buyout ..or if no buyout ...just to follow the Co .
Kiwi
Hi Steve , I think IVUS imaging is now considered better then an angiogram but only used so far in about 20% of cases due to reimbursement issues.
IVUS is better at detecting calcification inside arterial walls that may be constricting blood flow and thus enables better use of IVL technology .
I suggest you ask your interventionist / Cardiologist his views on IVUS for imaging and IVL for below the knee applications.
If he doesn't use any of these procedures maybe he could recommend some who does for a second opinion.
Most of the major teaching hospitals ( like UCSF out here ) will be using IVUS for imaging and when appropriate IVL to increase blood flow or to prepare the artery for a drug eluting stent.
Not medical advice ...just my opinion
Best of luck
Kiwi
O Not sure what you are arguing .
Your original link is pretty clear
O. LDL is a risk factor like smoking . We all know someone in their 80's who smoked a pack a day ....but population wide analysis shows lower life expectancy from smoking . Same with LDL levels. Population wide ...those with high LDL ...like over 200 mg/dl have more heart attacks strokes then those with LDL under 100 mg/dl
But its not the only risk factor
Its what you eat that matters , as well as how much exercise you get , genes , etc etc
Kiwi
Yep we need something like MITIGATE or BRAVE showing stellar results to rock everyone.
Many expected R-IT to fail back in 2018 . I think we had a contest at the time and I was on the low end of risk reduction ....had sold my position and was holding an option straddle / strangle ?that limited my downside but put me back in the stock once it crossed $6.
JL, Raf , Zip, North et al. were stead fast . R-IT would succeed ...and far better than most expected.
Kiwi
Tuesday, Shockwave Medical Inc ( SWAV ) shares traded higher following a Wall Street Journal report suggesting Johnson & Johnson ( JNJ ) is reportedly in talks to acquire the company.
Shockwave Medical ( SWAV ) is a cardiovascular medical device.
In 2022, Johnson & Johnson ( JNJ ) acquired heart failure device-focused Abiomed Inc. for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion.
Piper Sandler says it has considered Johnson & Johnson ( JNJ ) a potential buyer due to its interest in expanding into cardiovascular devices and strong financial position.
Additionally, there were reports in May 2023 indicating Johnson & Johnson’s interest in acquiring Shockwave Medical ( SWAV ). However, the Piper analyst writes that Shockwave Medical ( SWAV ) could thrive independently, maintaining the Overweight rating.
Piper’s analysis suggests that acquiring Shockwave Medical ( SWAV ) would likely require a substantial offer due to its profile.
Compared with Johnson & Johnson’s acquisition of Abiomed, which was about 12.5x consensus 2024 revenue without milestones and closer to 13.7x with milestones, it provides a benchmark.
Shockwave Medical ( SWAV ) reportedly sought bids around the mid-$300s per share, Piper notes, citing a StreetInsider report.
While a Johnson & Johnson-Shockwave Medical combination seems suitable, other major players like Medtronic Plc ( MDT ) and Boston Scientific Corporation ( BSX ) , with their focus in interventional cardiology and peripheral vascular, could also be interested.
Both Medtronic ( MDT ) and Boston Scientific ( BSX ) had shown previous interest in acquiring Shockwave Medical ( SWAV ).
The absence of obvious FTC issues suggests regulatory clearance wouldn’t be a major hurdle. A competitive bidding process could emerge, with Johnson & Johnson ( JNJ ) viewed as a strong strategic fit for Shockwave Medical ( SWAV ).
Price Action: SWAV shares closed higher by 2.07% at $322.61 on Wednesday.
Thx but I remember AMRN trading higher before end of year 2018 ...can U post a chart .
So a note from those days ...at least my memory of it .
Raf ( a poster at the time ) had made a huge profit . 60,000 shares from around $2 to as I remember close to $17 at the time of his partial sale .
His sale was to fund his children's education.....which I thought was a very smart move despite most on this board at the time insisting on nothing less than $40 a share .
Capt may remember better then I
But a chart Sept 2018 to its high that year would be nice if U have time
Kiwi
PS there has to be something else out there proving the benefit of Vascepa ...besides R-IT . Its finding it thats the problem IMHO
FFS. since you are great at graphs ...instead of the day the R-IT results were announced. Chart that day to end of that year .
thx
Kiwi
Come on Ram. Chk how obesity and diabetes have exploded in the US population over the past 30 yrs .
https://www.cdc.gov/obesity/data/prevalence-maps.html
O This is outdated info . Chk Dr Bhatt . No one now thinks LDL levels between 100-130 mg/dl are normal ..or should be consider safe .
High LDL is not the only reason some people have heart attacks .
Most of my wife's dialysis patients die from heart arrhythmia that set off a heart attack. Heart arrhythmia caused by a spike in serum K
Hi Steve .....well the good news is that you were released the same day .
Sounds as tho you had IVUS ( or OCT ) for pictures down to your feet .
Chk out
https://shockwavemedical.com/clinicians/international/peripheral/below-the-knee/
This is assuming calcification in the walls of these arteries
https://shockwavemedical.com/clinicians/international/peripheral/shockwave-s4/
Definitely watch the video on the risks using a balloon in below the knee and why that hasn't been a problem with IVL
I suggest you forward this to your Cardiologist / interventionist and ask them if they use IVL and would it be of any benefit for your situation .
Chk the safety record for IVL below the knee . They have developed a very thin system .
Not medical advice but hope it helps
Kiwi
Capt. The one and done shot is at least 5-8 yrs away ...even for the high risk HeFH patients .
We need something ( RWE data etc ) for Vascepa well before then .
Kiwi