Hi Golong OT
Early days . They need to run 2 P 3 trials in 2016 for their pain med ( alternative to opiates ) and will have data on their Acute heart failure drug mid 2016 . AGN has an option on their heart failure drug.
Their pain med drug is wholly owned by TRVN and is patent protected.
Alta Partners ( who backed ZSPH ) are major holders ( would need to recheck that but still believe so ) .
As you know I'm a fan of following Alta Partners . I think they took a major hit on ZFGN , but scored big time with ZSPH.
Alta Partners are usually in it for the eventual sale of the Co ...ala ZSPH
Have no idea on eventual price target but their pain med has the potential to replace SOC ( Standard of Care ) as its safer , faster acting and may facilitate earlier hospital discharge so save hospital $.
Do you know of competitors in the field and where they are in their trial ?
Do U see any red flags here . ???? .... they have $169m in cash end of 3rd Qt 2015.
Wife likes what she reads so far ( you know my wife : ) ..based on her experience in the ER / Hospital setting.
Anyway ..early days . probably a lot more action in RLYP over next 90 days .
I'm not in the camp that expects a BO offer this weekend.
I expect any Co interested would want to see the DDI ( drug / drug interaction ) results first.
Having said that tho , I'm sure RLYP would rather sell to some one like Sanofi , who already has a presence in the field , then try and launch Veltassa themselves with only a co marketing agreement with Sanofi.
So suggestions that other Co's are interested may force Sanofi to act.
I don't think RLYP really wants to go up against AZN in marketing spend for the HK market . A larger Co like Sanofi will do it so much better.
I think the market for Veltassa is bigger then what Berens ( MS ) is figuring ... but not as large as White Coat Mafia thinks . Actually the BAML survey may be fairly close .
Cardilologists seem to lean towards Veltassa , and Nephrologists towards ZS-9 ...for different reasons .
Anyway ..theres a market for both and the market for Veltassa may be bigger then I originally thought .
Hey Golong ...great day for you , congrats .
I don't currently have a position . ( took a quick 40% gain from $14 to $20 ).
May add on pull backs .
I'm less negative on RLYP then I used to be . ...the change ?...data on high blood pressure , the BAML ( Bank of America / Merril Lynch ) survey and Andy Biotechs post on Twitter .
Sanofi seems the natural for any BO.
Have you looked at TRVN ?
Alta Partners are big backers ( they also backed ZSPH ) and are known for guiding Co's thru trials to eventual buy outs . TRVN was just granted FDA Fast Track status . P 3 trial data on pain med in Q1 2016 .
Let me know if U take a look.
vme These are options that the CEO has that vest on a monthly basis .
This means that every month he can buy 20,000 shares for $7.40 a share and sell them at the current market price .
Expect him to do the same next month
Its a 10b5-1 trading plan
The shares sold are part of the CEO's 10b5-1 plan. He still has 737,877 options to buy the stock at $7.40 a share . They vest monthly ...so expect him to sell another 20,000 shares automatically , next month .
This is nothing to worry about for those of U long the stock .
While he can suspend his 10b5-1 plan he would be reluctant to do so , if there was potential BO offers, as it would smack of insider trading .
If Co gets bought , don't cry for the CEO ...he'll make out just fine.
I'm not impressed with the "non binding " supposed offer. I can make a "non binding " offer also ...don't mean a thing until penalty clauses are written in for non performance ( ie failing to close ) .
Anyway ...great day for all you longs .
Hope Golong et al are hoisting a few tonight .
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