Golong ..quick follow up.
Is the shelf life 3 months and then Veltassa needs cold storage . Remember my wife saying that was a hassle in the Hospital setting . I believe RLYP have submitted for 6 mth shelf life ....going from memory here please correct if necessary.
The feedback I still get is that ZS-9 will be preferred for Acute use but RLYP may have an edge for Chronic use ,for all the reasons discussed before .
Feedback I get, is that the initial paper work is cumbersome .
Also is Veltassa covered by Medicaid in CA ?
Initiate P3 development of Olicerdine ...1st Qt 2016. Their final meeting on the P3 design with the FDA was scheduled for the last week of March . Hopeful they will start P3 in Q2 2016
The 620 patient p2b study BLAST-AHF is fully enrolled with data expected in Q2 2016
Allergan to decide whether to exercise their option for this drug in 3rd qt 2016
Presentation at Pain Med Conference in April
just a quick preliminary recap . Feel free to add or correct.
Bullystick 1 Its unlikely the CFO would buy stock on the open market AND THEN seriously dilute the stock ...think about that .
Antonio ..would you want to be short a Co where the CFO was buying in the open market ?
The CFO obviously knows more about the Co's finances then anyone .....first to see incoming order flows , monitors cash burn etc etc ( I was a CFO of a small Sub Chapt S Corp for several years )
IMHO they have made a deliberate decision to do a massive spend to grab market share ....not unlike high tech / social media Co's in the same area ...SF down to Silicon Valley.
Its a huge gamble but the CFO wouldn't be buying open market unless she felt confident in some success .
Silver .....OT.....that was a great call on Smith and Wesson .
My only new biotech position recently was RLYP at $13.50.
Golong , who posts here and on the RLYP board and I , spent most of 2015 debating ZSPH vs RLYP . I was anti RLYP but my view has changed at these prices ....their CFO made an open market purchase the other day. Its a high risk spec play ....as is all small bio tech's : )
Post me on that board if you want to discuss further .
Yes did add a little ....but anything in Biotech seems a tough hold these days .
My biggest win so far this year is FCX , much to my surprise .
How are U doing ?
Since you appear to be the resident bear re RLYP , let me correct a few of your posts .
1) RLYP is NOT AFFY ...it is very very unlikely anyone will die from taking Veltassa .
2) You cite the AMETHYST -RN trial . NO adverse events of worsening CKD were considered by investigators to be related to Patiromer . This was a high risk population to begin with ...CKD stages 3-5 as well as type 2 diabetes. Show me the data that links any deaths specifically to the use of Patiromer ( Veltassa )
3) Safety is a key FDA concern so ZS-9 will be questioned over their hypertensive finding according to Dr Mark Perazella Nephrologist at Yale University School of Medicine ...so don't assume ZS-9 will get a totally clean label.
By the way , my wife did CKD research at Yale .
4) Dr Glassock ..Prof at Geffen School of Med UCLA and Dr Lipicky ( former director of the FDA division of Cardio-Renal products ) have both warned that the high hypertension threshold in the ZS-9 trials will impact the label ZS-9 gets .
These are known KOL's ( Knowledgeable opinion leaders ) in the field. Suggest you do not ignore them
5) Medicare /Medicaid coverage is just kicking in . My wife's Dept was working on the Veltassa Konnect forms late last wk. . So I suggest you don't write off Veltassa until you see the script numbers for March-May .
6) My own take is that on balance ZS-9 will be preferred for CKD patients , but Velatssa may well have the advantage for CHF Chronic care patients .
Crestor is the best Statin for those with high LDL Cholesterol nevertheless theres's a market for other statins like Livalo, Lipitor etc etc .....in other words I suggest you don't assume that ZS-9 will takes the entire market.
7) RLYP is on a "land grab "mission at the moment to gain as much of the market as possible before ZS-9 is launched . They have a severe cash burn that will probably peak out over the next 2-3 mths.
I think its to early to write them off
Re ZS-9 ..No evidence of sodium load or DD interaction ( as least not reported in data so far ). Fast on set of action in Acute and sub acute care for CKD patients . Some concern over use for Chronic care because of the cases of Edema reported..
Re RLYP .. They won't file for a label change ...3hr window till the 2nd half 2016 and FDA won't decide to early 2017.. 6 hr window does limit scripts for Stage 4 CKD patients who are on multiple meds.
Best chance is in Chronic care especially the CHF market ...but uptake may be slower for those patients
Biggest problem for RLYP is the cash burn . They need to really ramp scripts in March / April and May and hope that the ZS-9 gets at least a Sodium warning on its label..
By the way , I expect scripts to ramp as patients hate Kayexelate and now we have Medicare and Medicaid coverage .......BUT cash burn is still a big issue
EU is I think a bigger market but there I believe they have a deal with Fresenius
The reports I read show that Veltassa was added to the Medicaid and Medicare 2016 formulary 's on Feb 11th
Expect a jump in March script numbers to be reported April 15th.
Medicaid coverage is important .
I expect Veltassa to rapidly replace the use of Kayexelate.
Lurker Most CKD patients end up in the ER because they binged on high Potassium foods ..often family gathering /parties . Taking Veltassa on a regular basis reduces this .
Do you have any updated data on Medicare and Medicaid coverage ...this is key
Get busy .
Most of my wifes patients are on Medicaid ...find out if Medicaid provides low cost coverage yet, and report back .
Oldtrader.... as per their CC they have $285 m in cash and short term investments . In addition they have $30m remaining in their ATM.
There is no imminent financing need .
Medicare /Medicare coverage may not show up in this mths script numbers but they should by April 15th -20th .
Suggest U wait till U see those numbers and ZS-9's label before posting about a need for "imminent financing "
Rob ..well a few reasons in no particular order of importance
1) The Nephrology Depts experience with Omonty ( Ceo Orwins last Co by the way ) . That drug was used about 20,000 times before the first fatality , unfortunately showed up. Velt is not absorbed so little chance of that kind of risk but still , new drugs are often approached cautiously in their first year out .
2) You need Medicare and Medicaid coverage established and the drug approved on hospital formularies ...all of which takes time . Then you often need the head of the Nephrology Dept to start prescribing for his/her patients ...which then bless's it for all those working under him / her.
3) There are existing treatments ...Kayexalate , IV Insulin in the ER etc ..
ZS-9 and Veltasssa are both vast improvements over Kayex and ZS-9 may be considered in some ER situations , in fact once serum K is lowered in an ER setting , ZS-9 or Veltassa may be prescribed for Chronic use.
Kayex is often prescribed but rarely used for longer then a wk . Patients hate it.
4) The best opportunity for Velt is probably in the CHF Chronic care market , to optimize the use of RAAS inhibitors . Cardiologist will be telling some patients they need to add Velt to make their existing med work better, which may not be the easiest "urgent " sell.
I think there's often an inflexion pt where enough KOL's start using it their practice and encourage those working under them to also use it ...and then scripts take off.
The question for RLYP is how much of their $285 m cash on hand / short term instruments , will they burn thru first. They are projecting a huge cash burn of $275 m for 2016 but still have $30m left in their ATM.
Your posts are always interesting and informative .
Little short on time , so may get back later .
My wife does not want to disclose anything about her position or which hospital , where .
She does not own stock directly in any company that supplies meds for her patients..
She has no position in RLYP and did not own ZSPH.
She did warn me about Omonty ( AFFY ) Ceo's Orwins previous Co and said her hospital ( one of the largest in our state ) would not use it for at least a yr.
Altho she prefers the over all clinical profile of ZS-9 for her CKD patients especially in Acute /sub Acute , she does think there will be a market for Veltassa in Chronic care especially if RLYP can get a 3 hr prescribing window
Her dept prescribed Velt for the first time last week .
@hsch ..not currently . Dialysis is usually 3 times a week . There has been some talk of using Velt or ZS-9 as a bridge between sessions for high risk patients.
The main interest right now appears to be with those patients described in the previous post ...those that binge on the wrong foods and just can't seem to change that behavior......which by the way can be hard to do as beans, potatoes , yam, avocados , bananas etc are all high in Potassium.
oo.giant Depends how they do . Diet is a big deal in controlling HK . Some of my wife's patients end up in the ER because of eating high potassium foods at weekend family gatherings. They become listless / lethargic and family drives them into ER and sure enough high serum potassium.
So if her patients are doing this regularly then I suspect Velt will be long term use .
Its a cautious start at her hospital . Velt reduces peak concentration of some of their key CKD meds such as Amlodpine ( blood pressure med ) if they are taken to close together. The PDF says ...6hr prescribing window which is not easy if your patient is on multiple meds as many stage 4 CKD patients are .
Getting a 3 hr prescribing window would be huge for RLYP.
ZS-9 will also have its challenges . There is some concern about the degree of edema ( swelling ) with ZS-9 and some wonder if thats related to the sodium in ZS-9 .....which would be a concern with Chronic use . ZS-9 still looks best for Acute use..
Bottom line ...if , and its a big IF , Velt gets a 3 hr prescribing window and ZS-9 gets a Sodium warning on the label ...its a huge win for RLYP