The next key driver is whether or not they proceed to P 3 trials .
Does anyone on this board know if the efficacy warrants it .
On my first glance , appears so especially since adverse events are same as placebo.
But a P 3 trial will be a major expense , probably over 1,000 in the trial and run over a yr .
Then the FDA will want an Outcome trial to be underway before approval .
So its a major commitment .
Are the results good enough to justify it ?
Appreciate informed comments
Well Golong ...I'm up almost 50% on my RLYP position ...who woulda thunk : )
Certainly not me .
But time to take some profits .
Not suggesting anyone else do like wise
First , thanks to all those that contributed informed comment ..you know who U are :)
It made for an interesting and challenging debate .
Re the trial data
I wrote a post on the RLYP board explaining the trial ( or at least my understanding of it ) , to the many there who didn't understand the presentation.
It was data from their long term ZS005 study . They have enrolled 711 of the 750 patients scheduled .
The key data can be found on the ZSPH Corp site .
Key pts being
1) 64% were able to maintain normalized serum K on 5gms , a further 30% on 10gms of ZS-9 ....meaning that 94% of those in the trial were able to maintain normalized serum K on at most 10gms of ZS-9
2) There were cases of Edema and hypertension ( 7%-8% each ) and those risks will certainly be on the label but my impression is that they are probably ZS-9 dose related ....ie found more with those taking 15gms
IMHO both Veltassa and ZS-9 will be used .
Who gets what share of the market remains to be seen but the bottom line ....ZSPH has been bt out for $90 a share ( approved by both boards ) .
Time to be moving on .
Good luck all
Thank you for finally recognizing that your pontificating on a 90% drop out rate was INCORRECT .
RLYP's long term P2 AMETHYST-DN had data on 306 patients ...submitted in their package for the FDA.
I do not know if the FDA will accept rolling data from ZSPH ...or data to a certain pt or not .
If they don't it will be a huge plus for RLYP.
ZSPH will however , have more long term data by May 2016 then RLYP had for their submission
So Lurker ..you think you have ...." finally worked it out "
Hope springs eternal .
Now be a pal and work out how many patients will have completed 52 weeks before the May 2016 FDA decision data ...and how does that compare with the long term maintenance patients number that PLYP had at the time of their approval/
Tia ( thx in advance )
Adam yes I largely agree with what you just posted ...which is why I still own some RLYP
Sold all my ZSPH shares on Friday . Both boards approved the deal ...its a done deal .
Thanks to Golong ...my wife is now out spending some of the proceeds :)
( She read his post that I should buy her some thing nice )
Well praise be that you aren't the FDA .
Neither ZS-9 or Veltassa are absorbed . They act in your intestinal tract or colon and are pooped out.
Theres's years of data on both and the main concern is DDI for both .
Meanwhile ....as I type this ..somewhere in the US right now some one is probably in the ER with very elevated serum K and at immediate risk of a heart attack..
This situation may have been averted if said patient had had access to either ZS-9 or Veltassa ...whichever worked best or what the MD was most comfortable with.
FDA will have more data on ZS-9 then they had on Patiromer ( Veltassa )
If The FDA approved Veltassa , they will also approve ZS-9 .
With stage 4 CKD patients ...most are on meds to treat edema or high blood pressure already .
Adam would know more about the CHF patients but most ( if not all ) will be on RAAS inhibitors ( blood pressure meds .
The problem with RAAS inhibitors ( blood pressure meds ) is that some patients ...may only be 10% of those on these meds , experience elevated serum K levels as a result . Veltassa or ZS-9 will allow the more optimal use of RAAS inhibitors with these patients .
I'm not an MD ...just the feedback I get nightly from my wife who treats very high risk CKD and dialysis patients
Long term maintenance data is better on ZS-9 then Veltassa .
94% of those in the ZS-9n trial maintained normalized serum K with 5gms or 10gms of ZS-9
86% maintain normalized serum K on Veltassa ...from data available to date
So maintenance data favors ZS-9
Some of you seem confused on this .
I will try and give a brief explanation ...or at least my understanding
1) This is data from their ongoing ZS005 long term trial that will enroll a total of 750 patients
2) Not all 750 patients are enrolled in day 1 ...this may come as a surprise to some of you but large trials enroll over months if not years
3) These are INTERIM results . They are reporting data from different periods in the trial.
4) They want each patient to have 12 mths of data . The trial will span over 2 yrs .
So 61 patients are enrolled in the first moth . Another 61 are enrolled in the second month . Another 59 are enrolled in the third month and so on
5) What the graph shows is that the longer you have been in the trial the more consistently serum K is normalized around 4.6. That OVER 90% maintained normalized serum K on 5gms or 10 gms of ZS-9
6) These are statistically strong numbers ... P values are less then .05 .. which means low risk results are due to chance.
The data , altho strong , also shows ZS-9 will probably not be used by all CKD or CHF patients ...for all the reasons constantly echoed on this board .
I should follow up re some off the cuff comments from my wife.
Many of her patients are on Lisinopril .
This med lowers blood pressure and reduces edema risk...so if those concerns are alleviated with Lisinopril , why should she not use the drug that maintains normalized serum K the best ( ZS-9 ) .
Going from memory here re some off the cuff comments
ZS-9 lowers high serum K levels the fastest and maintains normalized serum K better , for more patients then Veltassa .
So why would you not start a patient on ZS-9 ?
Almost all problems with edema , high blood pressure etc ...even if its only 4%-7% of those studied so far ...will show up in the first 90 days .
At which time you can switch them to Veltassa .
If they have a clear history of prior edema , start them on Veltassa first.
Please explain what wrong with this course of treatment
Prepare to be blown away .
The FDA will approve ZS-9 .
Those who treat CKD and dialysis patients ( such as my wife ) will immediately use it because of its fast on set of action and its ability to maintain normalized serum K on 5 gm and 10 gm doses for OVER 90% of the patients tested to date.
Those with a history of Edema or develop Edema will be considered for Veltassa
Cardiologists who are concerned about a sodium load may start their patients on Veltassa ...but from the trench's of a high risk dialysis floor ...ZS-9 will be the go to drug for most with CKD
I sold my ZSPH position on Friday and maintain a small position in RLYP
Both drugs IMHO will be used but more likely to be 80% ZS-9 and 20% Veltassa
Great post .
For the rest of you .
My wife and I briefly discussed the ZSPH results over dinner .
From a Chronic Kidney Disease / dialysis perspective ...from some one who is in charge of the dialysis floor ( everyone else is at Kidney wk ) and runs labs every 2 wks on her patients as well as running a stage 4 CKD clinic.
The fact that over 90% of those in the ZS-9 trial can maintain normalized serum potassium on either 5gms or 10 gms of ZS-9 is HUGE news.
Thats not to say that some patients may not do better on Veltassa and maybe Cardiologist will prefer it for those patients with a history of edema BUT ZS-9 appears to be the " go to " drug for most Kidney disease patients with elevated serum K levels .
Just telling you like it is . I sold my ZSPH and hold a small position in RLYP
Re the chronic market
Over 90% of those on 5gms or 10gms maintained normalized serum K
That is better then Veltassa
Patients that develop edema will be switched to Veltassa. Those with a history of Edema may never start ZS-9
Almost all patients with edema or high blood pressure problems are identified within the first 6 mths of treatment .
We know which drug maintains normalized K best ( ZS-9 at 5gm and 10gm dose ) so I would assume that will be the first drug tried with a warning for those with a history of edema on the label.
Both ZS-9 and Veltassa will be used .
How the market is split remains to be seen
Your posts are nonsense ....and to think I actually wasted time reading them.
This is an ongoing trial
These are interim results .......91% have not dropped out .
Its an ongoing trial that is enrolling patients . The trial will span over 2 yrs with patients being in it for min of 52 wks .
So you are seeing data on the 61 patients who have been in the trial for 52 wks , followed by data on 112 patients who have been in it 48 wks etc etc etc they keep enrolling patients so then they have data on 394 patients who have been in 24 wks etc
What it shows is that serum K is being normalized at around 4.6 the longer you are on ZS-9 AND importantly 90% of those in the trial can maintain normalized K on 5gms or 10gms of ZS-9
Better then the results from Veltassa.
Golong et al
These are interim results
The full trial does not end until mid 2016.
So what you are seeing is the 12 mth data on the first 69 enrolled
9 mth data on the next 216 patients enrolled
6 mth data on the next 353 patients enrolled and so forth .
What is important here is the low rate of HK recurrence and how well normalized serum K has been maintained on the 5gm and 10 gm dose.
There was a very low rate of GI adverse events ...Veltassa is higher .
Re Edema ...90% of those that reported edema HAD A PRIOR HISTORY of edema ...SO expect those patients to be on Veltassa . Only 4.2 % of the patients required treatment
Once daily 5gms of ZS-9 maintained normokalemia for 64% of those in the trial . .....only 5gms of ZS-9 Golong Thats impressive
JMO ...Both boards have approved the deal so I sold my ZSPH on Friday .
I still have a small position in RLYP , but this data tells me that ZS-9 will get most of the market
Which stocks may go up 40% ?? Frankly some of this is so random . Take your ZFGN . Alta partners who are big backers of ZSPH also are backers of ZFGN and all is looking good until out of nowhere a fatality ??.
I haven't followed it so I'm not sure what happened .
A warning sign for me tho would have been the CMO sales . Usually I won't own a Co where the CMO has sold his stake .
I am following PRTO . Its a small company that may be able to improve fistuala patency ( blood flow open ) for dialysis patients . Its a problem my wife deals with regularly ..the fistualas that connect the patient to the dialysis machine regularly develop blockages after a yr requiring a new fistuala . PRTO has developed as vasio dialator to reduce this risk and if successful will be a major cast savings for dialysis providers.
P3 trial was enrolled ahead of schedule and results will be out Nov/Dec 2016 .
I believe their program is also FDA fast tracked . So when the data comes out its a binary event ...stock will either soar or crash and burn . Risk only what you can afford to lose.